Allison Kalloo, MPH

Allison Kalloo, MPH

Allison Kalloo, MPH is a patient recruitment specialist. She is the founding partner and communication lead of Clinical Ambassador, iParticipate and CliniVIVRE aimed at expanding minority access and broadening diversity in clinical research across stakeholders. She has held a variety of positions in the private, public, and non-profit sectors that span public relations, freelance writing, marketing, patient education and public health, and worked in multiple laboratories as an undergraduate research fellow. She was ultimately compelled by the vast creative opportunities to address disparities in innovative, meaningful ways. With a mission to impact health equity, enhance transparency, bridge cultural divides, and break the engagement stalemate in clinical studies, Ms. Kalloo now leads a team to deliver culturally relevant, patient-centric solutions to make sense of science, support study participation from front to back, and sample the candid opinions of real patients and the research-naïve lay public. Her agency also works with industry to support their clinical sites and enhance protocol integrity from the patient point-of-view. She is now one of newest members of the Medable PAC (Patient Advisory Council). Ms. Kalloo is a graduate of The Madeira School, North Carolina Central University, and Yale School of Public Health. She can be reached at akalloo@clinicalambassador.com and followed on LinkedIn, Twitter, Instagram and Facebook.

Recent posts by Allison Kalloo, MPH

6 min read

Call Centers and Clinical Trials

By Allison Kalloo, MPH on Apr 16, 2021 7:59:52 AM

If I were not personally and professionally involved in clinical trials myself— if I lacked the experience and navigational knowledge to fall back on, and if I did not possess the wherewithal and determination to pursue answers to my questions— there is no way I would ever participate in clinical trials. I don’t have the patience. It feels cumbersome and is burdensome.

 Why?

 Like many of you, my experiences with external call centers have been underwhelming at best. Unfortunately, this includes my perspective as an advocate for enhancing diversity in clinical trials, as well as on my own behalf as a patient/participant. The obstacles encountered have led to a host of frustrations. (Here is what has been routinely missing with themes in bold):

  1. What’s the 411? Finding a number to call in the first place!
  2. Anybody there? Getting hold of a live human and instead, reaching a recording from an answering service requesting that caller’s leave their name and contact information for a callback that may or may not happen
  3. Just answer my question. Being able to get study-specific answers because the answering service is set up to only refer callers to the caller’s local clinical site for more information (and again reaching the coordinator’s voicemail at the site)
  4. Am I in or out? Being able to get pre-screened on the first try (first call) rather than at some later time
  5. Taking my sweet time. Being able to speak with someone who was 1) knowledgeable about the study in question, but 2) also courteous, engaging, and not in a rush to get a caller off the phone so they could move on to the next one
  6. Are you speaking from experience? Feeling comfortable and connecting with operators who demonstrate authentic interest and concern about the human component of participating (rather than merely the mechanics of enrolling patients)

 From the outside looking in, call center operations provide precious little encouragement to participate in the way of customer service, and too few early encounters people can genuinely feel good about. The most apropos comparison that comes to mind is trying to get through to the DMV, and that’s being generous.

Once, there was a time that I was placing a call to a clinical site to make some preliminary inquiries on behalf of a patient. ClinicalTrials.gov had listed the Principle Investigator as the point of contact. He actually answered the phone with impatience and outright hostility, annoyed that I had called, demanding to know why I was calling him, and how I had gotten his number. It was horrifying. I followed up and did not let it end there. But I digress.

 As a rule, it is entirely too difficult for the average person to locate studies or the call centers that support them. It is too difficult to identify and to grasp the inclusion/exclusion criteria (due to the medical jargon) that would precipitate making such a call. And it is too difficult to speak with a live person who can clarify early clues as to what’s involved and on which a caller will base decisions about participating.

The call center must be viewed as an integral component of the clinical trial experience. Not ancillary to it. From the end-user perspective, call centers have routinely been so problematic that I have come to believe that— done poorly— they actually do more harm than good.

The fact of the matter is that call centers often provide the first impression of any study. If attention to detail is lacking, call centers can actually turn candidates off before they’re even screened. If callers feel as if their time and interest are taken for granted... if callers don’t feel respected and heard during the call, this brief encounter can become the last and will be an indictment of the industry and clinical trials as a whole.

To emphasize this point, it is in response to these experiences that we began providing a call center feature for our Clinical Ambassador clients to enhance patient recruitment when we were contracted to provide. We understand first-hand how critical it is to connect with people on more than a superficial, mechanical level. We recognized just how much this first encounter can be their introduction to the clinical trial process, sets the stage for the patient experience, and for many people of color in particular, is a critical building block of trust.

The importance of offering expanded hours of operation cannot be overstated. Among underrepresented patient populations, a significant percentage of the communities we seek to engage happen to work second and third shifts. These callers can encounter strict rules at work regarding the use of their cell phones and where personal calls can take place. Being cognizant and accommodating regarding the times that people are able to reach out is important also.

We train our Ambassadors to be familiar with the parameters of specific studies and to be ready to have real conversations about what it’s like to participate in a clinical trial— from the patient perspective. We have used our call center to help manage expectations so that otherwise viable candidates don’t get inaccurate impressions about what’s involved and get frustrated or feel otherwise unprepared for study participation and drop out.

Should callers choose to enroll in a study, those who have opted in have access to Ambassadors who stand ready to act as their advocates and on whom they can call every step along their participation journey. And not only do our Ambassadors assist callers by pre-screening for contracted clinical trials, we also perform study searches for “outside” studies when the I/E criteria of the original trial are not a suitable match for them and have a list of additional resources ready to share.

The rapport created from the get-go means that callers also refer members of their families, coworkers, and community members to the call center. Our contacts have reached out to us to mitigate logistics such as transportation and daycare when they have technical difficulties with their diaries (we have helped troubleshoot issues with tech support as needed), when they have concerns about an upcoming procedure, and even when they wanted to report not being treated well during their last visit. Peace of mind and someone to speak to means the difference between someone staying in a study to completion versus being lost to follow-up.

Site staff and typical call centers have neither the time nor the finesse to hold hands with participants. Clinical Ambassador enjoys being relied upon to be a reassuring voice for our callers. We make a point of letting them know that they can discuss anything related to their participation with us and that they will get nothing but straight-talk in return. We also escalate issues to clinical site administrators on participants’ behalf so that sites can have the opportunity to address problems as early as possible before patients get so frustrated that they drop out.

At Clinical Ambassador, our remit is addressing disparities in participation and advocating on behalf of equitable access and representation in clinical trials. In the interest of cultural sensitivity, our boutique call center takes the time to nurture relationships and allow interpersonal dialogues that address issues ranging from basic education about clinical trials to historical distrust to specifics on a study-by-study basis. As a result, communities of color who experience disproportionate disease burden and underrepresentation in clinical trials in parallel come to better understand participation in the context of diversity, equity, and inclusion.

Being responsive to a broader spectrum of participating candidates and allowing all to feel greater comfort about the unknown— in what can effectively be a foreign environment— is critical. The best call centers are those prepared to field queries from callers with a range of familiarity, that only hire operators who blend being personable with professionalism, and those that can be most accommodating to callers with physical/health or technological limitations.

Of course, there are call centers set up to collect information about patient experience and side effects in particular. But if patients find that their call center encounters have been more mechanical and impersonal and less than pleasant to that point, potential data about drug reactions will likely be incomplete at best because it may go unreported.

The take-home message is that there must be attention paid to “the small things.” In my experience, “real people” respond most favorably and are more likely to enroll (or remain) in a clinical trial when they feel confident in the people and the process, in what’s expected of them, and when they have a solid understanding of what they can expect from those involved.

From my experience, people who use call centers are interested in knowing whether they qualify, they desire a better understanding of study requirements, may need help troubleshooting technical issues, and just need reassurance that they can trust what they’ve agreed to.

Bottom line:

If any call center is not prepared to implement exemplary customer service, to be accommodating and to meet callers “where they are” regarding their knowledge, attitudes, and beliefs, and if they are not actively pursuing the balance between the technology of decentralized clinical trials and humanizing the patient experience, then don’t bother.

 

Allison Kalloo, MPH

 

 

5 min read

Wrestling with ‘Fabulous’ - When Cancer Goes Against Your Image

By Allison Kalloo, MPH on Mar 12, 2021 12:06:29 PM

Gloria was my surrogate mom and a role model. For a time.

                                   

Upon even casual consideration, it was so clear that her name was the perfect moniker for such a force of nature. But then she amplified it. Gloria claimed a nickname for herself that would live in infamy. If you knew her, it would be neither surprising nor a bridge too far. “The Fabulous One” and mom were best friends. My mother was fun in a dignified, more conservative way, while Gloria was flamboyantly “living out loud” and boldly unapologetic about taking up space in the world. Long before any of us had access to easy-peasy genetic testing, Gloria had claimed her African ancestry proudly and loudly, and just in case anyone was confused by her light-bright complexion. The fact that she performed in community theatre was such a natural extension of her personality that it was redundant. Gloria was a character. She never, ever left the house without looking like she had a date with destiny.

 Gloria wasn’t the life of the party, she was the party. Her go-to style was festive but regal. She was consistently decked out in generously flowing kaftans made of bright colored fabrics and usually in African or Indian motifs. She didn’t just walk, she pranced and glided and promenade. Whatever she happened to have on would gather around her, flappling and flowing in joyous movement while trying to keep up with her. Accessories were all but unnecessary, but she was never seen in public or in her own home without wearing a pair of earrings likely acquired from a festival which some local artisan had handcrafted. She believed in supporting fellow artists. In all the years I knew her, Gloria also wore prominent headwraps at least fifty percent of the time. When her head wasn’t covered, she rocked a short ‘do’ that was dramatic in itself at a time when most women were trying to emphasize length. Her style consistently included statement bangle bracelets that made noise. Her hands, that were in constant motion if not in a dramatic pose, were always adorned with at least one ring each.

 Gloria Davis Hill had a distinctive way of calling the house and asking to speak to mother. And it always brought a smile and a snicker. And her cadence was “extra” also, making certain that Dad or I would be. The fact that we recognized her voice was beside the point. “This is ‘The Fabulous One. Is your mother available?” I fondly remember Dad and I laughing at all the drama, The “extra.” But we all had come to relish her effervescent eccentricity. To quote one of my favorite song lyrics, she brought the sun out to light our lives up. I can dedicate that sentiment to both my mother and her best friend. And ironically, both of them were Black women who taken too soon in the prime of their lives. My mother’s health problem was chronic and spanned decades. Gloria’s disease was apparently known only to her and hit the rest of us like a bolt of lightning.

But, when the long distance phone call came from her daughter, I thought she was using gallows humor and making a morbid joke. I teased back and basically told her it was . Understand the fuller context of who Gloria was, but understand that I was quite literally waiting for her to arrive in New Haven by train. That day. I was to be picking her up from Union Station so that she could lead a series of cultural storytelling the following day during my portion of the International Festival of Arts & Ideas for which I had been chosen as an artist-in-residence. Gloria was slated to be a featured artist in my installation celebrating New Haven’s Sister Cities program. But Kimberly was not calling to say that her mother was running late. She was calling to say that “The Fabulous One” was dead.

 Wait.... WHAT!?!

 No, there hadn’t been an accident. It was not foul play. She asked me if I’d known that her mother had breast cancer. Because she hadn’t even told her daughters. Did I know?

 Wait...WHAT?!?

 There was an investigation opened as a result of someone (I forget who) finding her lifeless body. Medical officials quickly theorized based on visual examination that she died of breast cancer that had likely metastasized. It appeared that she had not sought treatment. It also appeared to have been the more aggressive form of invasive breast cancer. She had rebuked all forms of standard medicine, anyway. As the information evolved, it was clear that Gloria had not accepted what would be considered standard insurgery, radiation or traditional chemotherapy that would seem almost obligatory for anyone who loved life as much as she did, and who had as many loved ones in her tribe as Gloria did. It will always be impossible to reconcile her decision to suffer in silence. The pain she must have suffered as the masses in her breasts grew is absolutely unfathomable. The fact that she did it her way is an absolutely classic Gloria move.

 I was accustomed to Gloria using essential oils, burning sage and using natural aminos in her food. None of those things would have been red flags. A couple of months earlier— which would be the last time I was fortunate to in her presence— we had visited with her in DC and I went in for a heartfelt good-bye hug, I kind of noticed in that moment that one of her arms came across her chest but she hugged me back with the other. At the time, I assumed she was just adjusting the extra fabric of her kaftan. In hindsight, I think she instinctively blocked her chest to buffer the heightened pain she would have endured. In hindsight, that moment was both a “tell” and a profound metaphor. She loved me fiercely, but at the same time, was not about to let me in on this horrific secret. She loved all of us, but she could not bring herself to be seen as vulnerable or sick or dying.

 There is something to be said about doing things your own way. She would not have embraced any pity parties or fawning over her out of sympathy. Ironic, but I reckon that she was impatient with the appointments and side effects that would have been disruptive to not only her lifestyle and schedule, but her very persona itself. Having cancer did not fit in with her sense of self, and living out loud— And whether she was in the deepest denial or her own version of full acceptance will remain a mystery.

 The fact that Gloria did not receive treatment creates more questions. Was she under care but opting out of treatment? Did she lack insurance coverage and was her unwillingness really indicative of her lack of access? Rather than refusal, was it really because she lacked medical coverage? Despite her customary bravado, was she in fact intimidated by white coats and navigating the medical system? Was she cynical about medicine because she had lost her own mother as a child? Was she fearful because of historical abuses that went by the names of Tuskegee and Henrietta Lacks? Was she embarrassed because she felt she could have preemted a late diagnosis had she acted sooner? Was it all about not appearing weak or refusing to play “victim?” So many questions.

 Also this: Was the possibility of enrolling in a clinical trial ever brought up? I’m thinking not. All of the poignancy surrounding this tragedy makes me resolute. You will hear from me. Believe that. I applaud Gloria for maintaining her own agency and respect her for making her decisions without interference. But there comes a time when suffering in silence begs purpose. It will never be my way.

 I am eternally grateful for the beautiful friendship “The Fabulous One” granted my mother. I revere her for the love she showered on me. And the example she set for claiming your space and speaking up. I have also decided that martyrdom is not a good look or a desirable legacy. Denying loved ones the opportunity to know you more fully and in a truthful, balanced way. To rally to your aid. To feverishly help you explore treatment options. To identify patient support programs, to be supportive, and to navigate the unknown waters of clinical trials. To deny loved ones the ability to spend precious time with you and — to hold your hand and express our love for you— is not fabulous. Not in the least. I have learned from that, too.

 

Topics: clinical trials Oncology Cancer
9 min read

Getting Her Say: The Immortal Legacy of Henrietta Lacks

By Allison Kalloo, MPH on Feb 18, 2021 9:32:45 AM

What follows is a collaborative blog that commemorates the life and legacy of Henrietta Lacks written by two women of color— both members of the Medable Patient Advocacy Council (PAC). We offer our observations here in two parts.

It seems unfair that so many are unaware of her - a woman responsible for saving countless lives and counting. However, in celebration of Black History Month, I feel privileged to educate our readers about the unforgettable story of a young black woman whose remains transcend mortality and quantifiable impact.

 She was only 31 years old when she passed away, after failing multiple treatments for cervical cancer. She left behind five devastated children, her husband, and parents. Her name was Henrietta Lacks.

 Unbeknownst to her, a sample of Henrietta’s cancer cells had been biopsied by Dr. George Gey, the Head of Tissue Culture Research at Johns Hopkins Medicine. The hospital lab frequently obtained specimens from cervical cancer patients but found that average human cells had a brief shelf-life which resulted in virtually ineffective samples, the vast majority of which only survived a few days outside their human host. In an ironic twist of fate, given her tragic end, the cells biopsied from Henrietta Lacks were found to be freakishly durable. Gey was able to consistently propagate these cells in tissue culture. Paying homage to Henrietta Lacks’ monumental contribution to science, Gey did the decent thing and named the cell line for her.

 As it turned out, HeLa cells were unlike any other, both replicating and mutating under direction at a rate that provided ample cell supply for future, groundbreaking discoveries in a broad array of research conducted by scientists all over the world. In fact, growing HeLa cells quickly became a very profitable business that struggled to keep up with demand.

The beauty of it all? By utilizing the HeLa cell line, scientists have made significant advancements in medicine without having to resort to tying their discoveries in live human beings as their first step. Scientists could now pursue all kinds of novel treatments by testing in HeLa cells first.

 The uses for HeLa cells quickly expanded beyond cancer research. Most notably, the cell line played a significant role in developing polio vaccine and subsequently eradicating the disease. Additionally, Henrietta’s special cells have had an impact on a long list of scientific breakthroughs across a wide spectrum of therapeutic areas and applications including but not limited to virology, genetics, and even in ‘space microbiology.’

 The infinite contribution of Henrietta Lacks to science inspires me as a woman, a person of color, a patient, and an advocate. While it’s upsetting to think that she’ll never know the magnitude of her contributions, I feel privileged to share that out of Henrietta’s tragic story has come so much good. Her posthumous impact on the entire human species is one of the most fascinating stories I have ever heard and will forever be etched in my mind and heart.

 — Sumaira Ahmed, a member of the Medable PAC

 

As Sumaira outlined, the unusually robust HeLa cell line utterly revolutionized medical research. As a matter of fact, famed scientist Jonas Salk used the HeLa cell line to develop the polio vaccine, which sparked mass interest in these cells that lead to massive and commercial efforts to clone Henrietta’s cells starting in 1955. Since that time, registered patents involving HeLa cells have exceeded 10,000 (ten thousand). Researchers have consistently benefitted by using Henrietta Lacks’ cells to study disease en masse, and millions of living people (three generations to date) have benefitted significantly, mostly unbeknownst to them. It’s accurate to say that literally millions of human lives have been impacted by the knowledge derived from testing the safety and sensitivity of new products and substances on HeLa cells.

But the story of Henrietta Lacks is an object lesson in how betraying public trust impacts the entire scientific community. Adding more insult to more injury, Henrietta Lacks’ family were entirely clueless about her scientific legacy and the existence of HeLa cells until 1973. At that time, her living relatives were contacted not to finally extend an apology, an explanation, or compensation for what Henrietta had provided the world, but to further exploit her relatives in pursuit of extending their library of genetic samples. The family represented the potential to gather more medical insights from the people who carried the same unique genes.

Exposure snowballed when the BBC screened an award-winning documentary on Lacks and HeLa, which prompted Rebecca Skloot to author her very successful book titled The Immortal Life of Henrietta Lacks. The rest has become history, albeit a conflicting blend of medical miracle, systemic racism and patient abuse.

You see, the story of Henrietta Lacks is also a profile highlighting the lasting harm of medical mistrust based on historical abuses, unresolved accountability, and modern-day urgency to address disparities in the very patient community from which she came. All of these issues swirl around, but for people who look like Henrietta and my mother, the conflicting issues persist.

At the heart of this story lies the issue of trust— or lack thereof. As a community, we experienced the Tuskegee Syphilis Experiment through the lens of our grandparents who depicted the medical establishment as stone cold, self-serving and paternalistic. We then witnessed our parents’ palpable and righteous outrage at Henrietta’s demise. And for millennials who have now witnessed a barrage of injustices in real-time— sometimes up close— pursuing medical solutions to persistent health disparities against the backdrop of police brutality and other overt forms of toxic racism keeps eager participation at bay. Not surprisingly, simmering anger is the more likely response, and it is sometimes not even beneath the surface. Thus, is it any wonder that concerns about exploitation. on repeat,have become multigenerational in this environment.

 The exploitation of Henrietta Lacks took place in a void of medical ethics that has since been addressed in an official and regulatory capacity. But the reality is twofold: This story is sadly emblematic of a bigger history of immorality fueled by ongoing systemic racism, but is alive in our collective memory of how that feels and these issues cannot easily be teased apart. And yes, it is ultimately ironic that our distrust can itself be a barrier to better outcomes and is outright harmful to the very people most likely to benefit from medical progress. You will observe that “betwixt and between” results in a schizophrenic relationship with health and healthcare, yet we sit here at this intersection.

 Given the dark legacy of medical research conducted by virtue of sanctioned racial discrimination, it is entirely unsurprising that African Americans continue to report greater mistrust of physicians and medical researchers than any other groups. A 2006 study found that 44 percent of African Americans reported low trust in health care providers compared to one-third of white patients. When consistent, positive, or consistently positive interactions with physicians are scant, so too is the trust.

Don’t ask why Black people would not move swiftly toward providers made more accessible through Obamacare or toward interventions that would appear to suit our own best interest, or to participate in clinical trials. Instead, ask how minorities— and Black people in particular—would not be leery of medicine and all things related to it.

 It’s an undeniable fact that minority groups have been touched by racism and discrimination in the health care system. However, so is the harm that comes from withholding our trust in the medical sphere. Medical distrust (not “mistrust” because in this case, lack of trust is based on actual observations or experiences) has dangerous, even lethal consequences for those withholding their confidence in the context of health. Numerous studies found an association with lower health care engagement, compromised medication compliance, and (surprise!) less participation in research meant to address disparities and with the intention and potential to enhance health outcomes.

 As contentious relationships within the clinical care environment persist, it cannot help but feed stereotypes of Black patients being "difficult" or disagreeable, which can ultimately result in some providers justifying the suboptimal care still documented by some Black patients. Not surprisingly, this feeds a vicious cycle of unsatisfactory clinical encounters and patients who respond with more distrust and a reluctance to engage in practices that can ostensibly protect against the need for more aggressive medical interventions. And so, it goes.

 Reluctance on the part of African Americans and other minority groups to participate in medical research risks significant harm to the health of our communities. When medical treatments like cardiovascular disease, diabetes or cancer drugs are derived from exclusively white research participants, they've been found to be less effective for minority groups. Or, at the very least, adjustment of dosages was required in order to be more effective in some cases, and less toxic in others.

While the most basic common sense says that equal inclusion in research trials for people of all races and ethnicities is essential to finding the best treatments for all patients, it doesn’t address the issues of trust.

 Racism, paternalism, deception, exploitation and injustice permeated both clinical care and clinical research during Henrietta’s lifetime. It is true that the world is not quite the same as it was 70 years ago, ethically or medically. But, it must also be said that just coming to grips with medicine's past is not enough. We have to acknowledge the many ways those antiquated attitudes have been stoked, reignited, and reinforced under the deplorable guidance of recent administrations. Progress has experienced a setback. Much must be addressed again as if for the first time. However, we cannot let the grip of the past and the psychosis of white supremacist ideology be a barrier to delivering on the promise of medical ethics, health equity and doing what pragmatically serves everyone's health today.

 Henrietta Lacks was singularly responsible for ushering in better screening tools, diagnostics, and treatments across the spectrum and beyond the speculum, if you will. The advent of pap smears and the HPV cervical cancer vaccine are but one area of impact by HeLa cells. Henrietta’s legacy is, at once, invisible and undeniable, both microscopic and telescopic. Her epic cells have reduced pain and suffering and extended life of millions of human beings. The irony that she would never know this always catches me in the throat.

 I don’t have all the answers, but I do have perspective. As someone who is also a Black woman, who is a scientist by training and who was raised by a Black woman scientist, who is now an entrepreneur who has carved out a niche in patient recruitment and inclusion, and who also remains a cautiously enthusiastic participant in clinical trials, I will tell you that the answers must be bathed in a solution of transparency and allowed to germinate in a basic acknowledgement of the larger social construct in which we operate. The answers probably require that you continue to endure more venting about these things on the patient and community side. There will be no avoiding that. The catharsis demands it, actually. Just pledge to be better listeners moving forward, in both structured and casual settings. It should also go without saying that the solutions we seek should include regulatory policy that actually possesses ‘teeth’ and consequences for our industry’s lack of compliance diversity standards that are still lacking in many areas. Enough is enough.

 And, as someone who very easily sees her own mother in the profile of Henrietta Lacks, her story sits a little differently in my spirit. The obligation to address this chasm is definitely personal, so you’ll have to forgive my impatience.

— Allison Kalloo, MPH, a member of the Medable PAC

 

Source:

https://www.hopkinsmedicine.org/henriettalacks/

Topics: D&I Diversity Henrietta Lacks, HeLa Cells
9 min read

You Believe in Diversity, Equity and Inclusion? Okay. Show Us.

By Allison Kalloo, MPH on Jan 18, 2021 12:10:30 PM

We are excited to announce the addition of Allison Kalloo to Medable’s Patient Advisory Council. She is the founder of Clinical Ambassador and iParticipate, and is a passionate advocate for diversity in clinical research.

It is my hope that you will read this over and over again. 

The fact that minorities (and African Americans in particular) are over-indexed in measures of poor health outcomes is nothing new. The coronavirus crisis has simply highlighted persistent disparities in both disease prevalence and the underrepresentation of minority populations in clinical trials. The fierce urgency to find real solutions to combat this deadly virus means that longstanding inequity may finally be getting the exposure it has needed. Hooray for silver linings and tipping points. This surreal period in human history confirms for me that there is no better time to dream than in the darkness. 

Imagining the possibilities translates loosely into dreaming of dynamic public awareness campaigns, diversity-tailored programs, patient-centric campaigns, and more culturally sensitive protocols overall, and maybe even new interventions based on cutting-edge precision medicine initiatives that would allow medicine to take better care of its most vulnerable populations. Imagining the possibilities in the age of COVID also means being bombarded by news coverage from all corners discussing this need for diversity and the scientific community’s newfound dedication to achieving it. But if my hope and excitement are tinged with irony and incredulity, there’s a litany of historical reasons for that.

Industry stakeholders are appropriately acknowledging the need to be deliberate about recruiting participants of color. Attention here is long overdue. But sponsors are also more than familiar with the challenges they have faced with doing so. Failing to recognize pharmacogenetic and drug metabolism differences aside, being Black in America and being made to deal with systemic racism has proven to be its own risk factor. There is zero doubt that America’s unseemly past has managed to make African Americans fearful of stepping up to take advantage of participating in the very research that has the promise to save lives. Ironically, too few people know that the heinous Tuskegee Experiment had its own silver lining in being singularly responsible for the advent of informed consent. 

COVID-19’s growing toll on all Americans, but the wide disparities by race reveals that the heaviest losses among Black and Indigenous Americans nationwide—more than twice as high as the rate for Whites and Asians. Attention is now on getting Black and Brown people to participate in clinical trials in numbers that reflect disproportional disease burden.

The industry needs help communicating about what vested interest in research really means, and the pandemic is poised to drive the point home. There has to be a reconciliation of these facts with all stakeholders— that when studies do not reflect the diversity of the real world, not only will modern medicine continue to be complicit in perpetuating disparities, but those minorities who categorically refrain from participating in research will be complicit in less than favorable health outcomes and our own demise. This is no time to sugarcoat the facts. I tell people as often as possible that we simply cannot afford to sit this out. Frankly, we should consider inclusion in clinical research as much a social justice issue as protesting against police brutality. 

While I am a staunch advocate for diversity in clinical trials and stepping up to participate (and I have, in more than a dozen studies over the years), there has been an elephant in my headspace taking up room when I sat down to coalesce my thoughts on the matter. Regardless of our tone of voice, body language, or facial expression and regardless of whether we might have been justifiably angry enough to “burn [edifices] down” there is a collective acknowledgement that we have to be able to estimate the blowback to speaking truth to power. These mental gymnastics have themselves caused trepidation and exist as a source of justifiable anger. These communication challenges inherent to issues of diversity, inclusion, equity, social determinants, historical injustices and so forth — whether real or imagined— bring about additional obstacles downstream when trust and collaboration must be negotiated. But here is where we must start:

Whether it’s a matter of hiring Black staff, recruiting Black executives, asking Black community members to join your community advisory boards, contracting with Black-owned companies, or asking a member of your patient advocacy group to lend some perspective to publications calling for more diversity in clinical trials, I can guarantee that we all do some form of this calculus in our heads:

Are you really ready for the truth? Can you handle it? And if you can, will there be tangible evidence of the changes we recommended? And what will we be the price for making the establishment uncomfortable or disrupting the status quo?

We— Black and Brown people— are not inspired to believe you when you say that diversity is important to you if you don't put skin in the game. Making public statements that include the phrase “Black Lives Matter” will fall flat without adequate follow through. What will your ethos matter if you don’t actually DO something? It is no longer acceptable to say that this is not acceptable. We have no use for your anger. We need your action. 

Epic, concrete and systemic changes are needed and will be the only context under which real clinical trial diversity will transpire. We call bullshit on any minority recruitment endeavors that coexist alongside any of the following. Wherever the shoe fits, consider the cognitive dissonance you bring about when you allow these scenarios (and in no particular order):

  • Whenever you treat Black and Brown communities as monolithic groups who have the same life experiences, backgrounds, income, education, language, customs, interests, attitudes, and opinions in common. We don’t. 
  • Whenever you pile people of color into presumptive stereotypes and shallow narratives, not the least of which is that Black people can only be reached through the church. Wrong.
  • Each time your approach to minority inclusion is to treat unwillingness as cliche and to presume that distrust among Black people is tied only to Tuskegee, Henrietta Lacks and the infamous atrocities of the past. Today’s racism is more relevant to reluctance.
  • Every time you fail to factor in relevant disease prevalence data— or to acknowledge patterns of participation disparities in those areas— when designing protocols or planning recruitment initiatives.
  • Whenever privilege allows you to ignore the NIH mandate for inclusion and you complete enrollment without adequate minority representation; AND, whenever the NIH allows you to continue to receive federal funding in spite of your noncompliance.
  • Every single time you do “just enough” to comply with the FDA for approval of your NDA, and when you have spent more time crafting the explanation for your shortfalls than you have investing in a real plan to prevent them.
  • Each time you use mere familiarity or convenience as your site selection criteria when these sites possess no actual history with— or cultural connection to— the communities of color you seek to enroll.
  • Whenever you presume a team approach or collaborative mentality and rely heavily on physician referrals to fill your study’s patient rosters.
  • Whenever physicians are neither provided accessible education about clinical trials, challenged to embrace medical research as a viable treatment option, nor expected to broach the topic in consultations with their patients.
  • Whenever your study goals and timeline so blind you to the humanity of your target patients that you fail to properly introduce yourself first, or invest in establishing a relationship and a foundation of trust.
  • Whenever you implement the strictest (and least realistic) inclusion/exclusion criteria for participating in your clinical trials, creating de facto barriers to diverse, equitable and inclusive participation at the study gate.
  • Each time you slash a patient recruitment budget, minimize its importance, fail to make patient recruitment a priority, or allow it to be an afterthought.
  • Whenever you complain that diversity is “too expensive” or decide in advance that minority recruitment is too complicated. 
  • Whenever the IRB or any regulatory body alters the language that consultants have suggested related to anything patient-facing, including marketing, education or outreach— as if authority alone is synonymous with transparency or drives engagement.
  • Whenever you don’t make space, set aside resources or allow time for an external task force to review and assess cultural sensitivity and patient-centricity of study protocols and to identify biases and barriers.
  • Every time you default to doing business with majority-owned (read: White) marketing firms to resolve minority representation simply because they seem “safe” and familiar.
  • Whenever fear of change forces you to default to using status quo recruitment and retention activities simply because they seem “safe” and familiar.
  • Whenever you fail to establish quantifiable recruitment expectations for recruitment brokers based on demographics that reflect known data about the therapeutic area.
  • Every time you second-guess the pricing, professionalism, scalability and ability to deliver the goods and services from a small minority-owned business when you would be less likely to treat a larger business of privilege with comparable scrutiny.
  • Whenever you solicit feedback from consultants (whether professionals, study participants, patients, or members of the community) and fail to implement their recommendations— or fail to give them credit and compensation for their time.
  • Whenever your perception of expertise is cloaked in whiteness first.
  • Whenever you rely on study participants to take risks while you remain risk-averse in every possible way.
  • Whenever you set high conference fees that are functionally exorbitant to attendees of color [often classified as historically underutilized businesses (HUB) and/or certified minority- and women-owned businesses], thereby making their attendance cost-prohibitive and effectively shutting out competent and competitive collaborators and doubling down on disparities.
  • At the points where you compensate keynote speakers to address diversity, equity and inclusion, and that person is not Black or Brown; conversely, whenever you expect minority experts to provide that expertise pro bono.
  • Whenever your website’s homepage lacks a “DIVERSITY, EQUITY & INCLUSION” section— or it is difficult to find readily— it belies corporate DEI policies and the stated priorities of your organization. 
  • When your public overtures regarding dedication to diversity, equity and inclusion (DEI) — whether at the corporate, HR or patient recruitment level — are not matched with adequate resources or a timeline of changes for which you’re also willing to be publicly accountable.

While the system has long been broken— and addressing it will require more than  publicity statements and grandiose gestures— I recognize the value in framing these issues in such a way that you will know that solutions are within reach. 

Let’s discuss this in an open manner that benefits the greater good. Let’s take a deeper dive and embrace the powerfully positive approaches we can cue up that will make the most difference. 

In the blog series that will stem from this, I plan to explore dynamic recommendations from multiple sources (yes, more than just my own), and to showcase a tantalizing variety (read: diverse array) of people, organizations, policies and clinical interventions poised to change the landscape for the better over time. I hope you will stick with me for the ride. 

But in the meantime, know that It will take much more than throwing a fistful of money at a rescue rather than planning better from the beginning. 

Start by taking a hard look at the invitation list you inadvertently created with your protocol design. Who are you inviting to your party?

If you are sincere about filling the studies of tomorrow with a broader spectrum of individuals, implementing the tools of transformation will require the guts to be honest with yourself

One can’t expect to tease apart attitudes about participating in a clinical trial from how a person feels the system treats them. And this absolutely cuts across socioeconomic class. Even African American professionals and other high income earners openly express concerns about participating, and others of us harbor misgivings that still linger in the back of our minds. 

Reconciling these issues is fundamentally a matter of perception. Getting to a better place in DEI work will demand significant outreach going forward— both broad and deep. Lamenting lack of diversity in studies while not doing the work to get out of your own way is disingenuous at best.

As an industry that uniformly proclaims how dedicated it is to diversity, you will want to pay attention to this pivot point in time. This is your opportunity to actually rise to this occasion to DO something. Make it profound. 

Now is not the time to hold back.  

Industry will need to address head-on the hesitancy of many who came by theirs honestly. But building trust is not rocket science. It's about building relationships and employing trusted messengers outside your direct influence. 

Reaching out and across effectively is hinged on those in charge of clinical trials being more trustworthy. In other words, you first. Show us what you’re working with.

As for me, nobody is more interested to see how this goes.

—Allison Kalloo, MPH



Topics: D&I Diversity Inclusion Equality
5 min read

Fit for a King: Bending the Arc of Legacy Toward Action

By Allison Kalloo, MPH on Jan 18, 2021 12:07:19 PM

We are excited to announce the addition of Allison Kalloo to Medable’s Patient Advisory Council. She is the founder of Clinical Ambassador and iParticipate, and is a passionate advocate for diversity in clinical research.

More than ever, I am convinced that anyone who does anything has got to hold a deep and abiding belief that one person can actually make a difference in the world. Dr. Martin Luther King, Jr. clearly believed that. My mother believed that. I believe that also. I had little choice.

My mother was a spitfire who radiated warmth and grace, and she very deliberately instilled in me that I alone am enough to have an impact. That my unique talents and passion are actually supposed to be of service to the world. 

Both Dr. King and my mother had an abiding commitment to civil and human rights that stemmed from their fundamental belief that we are all called to take action…each of us. That being “created equal” also confers an equitable obligation—no matter who we are, where we’re from, or “what” we’re from—to use our talents for the greater good. 

My mother grew up in the racially hostile south, coming of age during the 50’s and 60’s where not having access to equitable health care easily set into motion poor health outcomes. My mother was class Valedictorian and the first to go to college in her family. She’d been an avid reader from early childhood and became enthralled by science. GIven her chronic health struggles exacerbated by discrimination and lack of access to health care, the fact that she did go to college was remarkable. 

I was recently granted a copy of her college admissions essay, which she wrote longhand in 1959 at the age of seventeen. My mother’s essay ends with the following passage: 

“In light of the above facts, I feel that North Carolina College is the institution which will prepare me adequately to adjust myself to the various situations of life as well as equip me in such a manner that I might make a definite contribution to society.”

—Marian Suitt

Among hundreds of other young, gifted and Black students who attended HBCUs and who remained somewhat insulated from the outside world, they were fully cognizant of navigating the segregated south. She and her classmates felt duty-bound to participate in the lunch counter sit-ins later credited with being catalysts of the civil rights movement. She would also attend the March on Washington in 1963, the summer she graduated. 

The civil rights struggle was not just an abstract captured in grainy black & white news footage. It was a vivid first-person experience that my mother lived. When she retold the stories, it was in riveting detail. For me, the earliest and most compelling images of who Dr. King was and what he represented came straight from my mother’s mouth. 

Armed early on with the prospects of not having a lot of time, my mother possessed a sense of urgency and decisiveness about everything. She would become a lead scientist for the District of Columbia Bureau of Laboratories as an expert on swine flu, rabies, and smallpox. My mother was a trailblazer and scientist and the context for my first superhero being depicted in a white coat.

In the wake of the coronovirus pandemic, not only have I thought of my mother for the scientist she was, but ironically, I’m reminded of her every time Dr. Anthony Fauci is mentioned or interviewed. You see, Dr. Fauci is my mother’s peer and was a colleague. My mother was a virologist, too. They attended the same scientific conferences and Dr. Fauci’s name was often the topic of dinner table conversation. 

When her health began declining further, my mother made the bold decision to participate in a clinical trial. She signed up for a trial at the National Institutes of Health— led by Dr. Fauci. As she shared with the family, she knew participating would not save her life. Her participation would help somebody else, and that’s what mattered to her. And she was uniquely equipped to recognize how important representation was— even in the long shadow of the Tuskegee Experiment. 

It’s impossible to look around and not be taken aback by how far we’ve come in the last thirty years since my mother’s enrollment in that clinical trial, but also how far we still must go if we are to make good on Dr. King’s dream of equality. 

Despite profound medical and technological advances that have occurred even recently, racial and ethnic minorities have failed to achieve equal health outcomes. By virtually every measure, minorities experience higher morbidity and mortality rates than the general population— even when income, education, and other socioeconomic variables are controlled for. One doesn’t have to wonder what Martin Luther King would have thought about the disproportionate burden of disease among certain groups. He actually said it: “Of all the forms of inequality, injustice in health care is the most shocking and inhumane.”

Exactly a year ago on Dr. King’s birthday, I was leaving a study appointment for a trial I was participating in. As I walked through, I locked eyes with an elderly Black woman seated in reception. We both did ‘double-takes.’ I smiled at her. She smiled at me. (We could see each other smiling because it was pre-COVID and neither of us were wearing masks). Turns out, she wanted to accompany her niece to her study screening. She told me that while she had been a bit leery, they decided to show up anyway. I remember telling her that I thought minority participation in clinical trials is about  health equity and social justice. That on a personal level, I think of participating as an issue of awareness, empowerment and exercising options which include access to cutting-edge healthcare. I’ll never forget her response. She said, “You know, you're right. I hadn’t thought of it that way. It is important that we participate. I'm glad you took the time to speak with me.”

I felt emotional walking back to my car. It hit me that my encounter was infused with Dr. King’s spirit. I had also experienced validation that in our increasingly digital, tech-driven world, face-to-face connections (and virtual ones for these times) remain the holy grail of connecting with people and we need to make sure we give this brand of magic its due.

It’s hard to imagine that any of our high-tech modern conveniences could possibly have enhanced Martin Luther King’s profound impact on the world any more than he did. His movement was simply about connecting people. 

My mother and Dr. King both lived by an edict that we are all beholden to do something significant. That we all carry an obligation to do more than just dream. 

I’ve come to realize that the concept of legacy is not only something that remains of you after you have gone. Legacy is actually what you create daily. It’s what you’re actively building, and all of what you do pays homage to those who’ve invested in you. 

So, may it be for us today and always, that the best way to show respect for Martin Luther King’s principles—and that of our ancestors—is to DO SOMETHING of service to humanity.  Do something that MATTERS. Pay it FORWARD.

“Now, therefore,” wrote Barrows Dunham, “since the struggle deepens, since evil abides and the good does not yet prosper, let us gather what strength we have, what confidence and valor, that our small victories may end in triumph, and the world awaited be a world attained.”

Happy Martin Luther King Day 2021!  

Allison Kalloo, MPH



Topics: life sciences D&I Diversity Inclusion MLK
1 min read

Q&A With Medable PAC's Allison Kalloo On MLK Day

By Allison Kalloo, MPH on Jan 18, 2021 12:06:10 PM

We are excited to announce the addition of Allison Kalloo to Medable’s Patient Advisory Council. She is the founder of Clinical Ambassador and iParticipate, and is a passionate advocate for diversity in clinical research.

Each year, on the birthday of Dr. Martin Luther King Jr., the nation takes a moment to pause, reflect and think back on the life and impact of his work. 

Today, our own Patient Advisory Council member Allison Kalloo sat down with Medable CEO and co-founder Michelle Longmire to incite a moment of pause and reflection, by discussing the very real and continued issues and challenges that African American communities face in our own industry.

 

Allison has had a remarkable life shaped by the work of Dr. King, her mother, and trials and healthcare in general, and she presents the industry with a number of challenging thoughts and questions that should make us all stop, pause, and reflect on the work that we do everyday, as well as the lives we lead outside of Medable.

Topics: life sciences D&I Diversity Inclusion MLK