5 min read

January 2021 Pulse Check on Decentralized Clinical Trials: Looking back on 2020 and at What Lies Ahead in 2021

By David Swanger on Feb 5, 2021 11:10:12 AM

Throughout 2021 we’ll take a look at the latest developments in the realm of Decentralized Clinical Trials. Read this monthly roundup to discover the latest trends, insights, and modalities of decentralized clinical trials.

2020 was a pivotal year for those of us who work in clinical development. Covid-19 threw the ultimate curve ball to patients, investigators, CRA’s, and just about everyone else who contributes to ensuring that clinical trials are reliably executed. Suddenly the status quo of asking patients to visit a clinical site for the lion’s share of scheduled assessments was no longer tenable. And as a result our industry turned to Decentralized Clinical Trial (DCT) methodologies for both the continuity and rescue of existing studies as well as the design of new ones.

As we entered 2021 we’ve observed a subtle and important shift in the thinking of many of the stakeholders we interact with on a daily basis. Rather than asking “why” a DCT makes sense, individuals have moved beyond this, now asking “how” to implement one. 

Medable started the month by sharing lessons learned in how we successfully deployed DCT’s in 2020. We also started to look forward to how clinical trials could be reimagined with DCT’s serving as a new foundation. We covered these topics in depth at JPM’s Annual Healthcare conference by  leading five different sessions at the conference. You can view each of the sessions here:

The Digitalization of Clinical Trials

Michelle Longmire Founder and CEO,  Medable,  Maria Fotiu Executive VP of Decentralized Solutions, Syneos Health, Cathy Gao – VP, Sapphire Ventures, Juliet Moritz – COO, Illingworth Research - 

Hindsight is 2020: Lessons learned from DCTs and 2021 predictions

Alison Holland Head of Decentralized Trials, Medable and Craig Lipset Advisor & Founder, Clinical Innovation Partners 

Interview with Rasmus Hogreffe

VP Decentralized Clinical Trial Innovation at Medable 

 Rerouting: How Real-Time Patient Data Will Drive the Future of Healthcare Michelle Longmire with guests: Andy Coravos, CEO, Elektra Labs, Maria Fotiu, Executive VP of Decentralized Solutions, Syneos, Thomas Switzer, Digital Health Scientist, Genentech, Priyanka Agarwal, Director and Head of Digital Health, Myokardi

And finally, you can read VP of Decentralized Clinical Trial Innovation, Rasmus Hogreffe’s overall thoughts and reactions on this year’s JPM’s conference here, on his blog. 

In January of 2021 we also welcomed two important leaders to Team Medable:

Andrea Valente joined Medable as our new Chief Operating Officer to scale the global delivery of Medable Decentralized Clinical Trials. As research and patient care move from the controlled environment of the clinic to the home, focus on operational excellence is paramount. Valente is a proven expert in operationalizing patient technologies in clinical research. She played an early role driving adoption and scale of electronic Clinical Outcome Assessments (eCOAs), one of the first technology categories to interact directly with patients outside of clinical settings. She most recently led development and launch of Oracle’s public health platform to address COVID-19 pandemic response and vaccine trials in the U.S., UK and several developing nations. You can read more about Andrea joining Medable here. 

Parag Vaish joined Medable as our new Chief Product Officer to transform the clinical trial experience for patients and clinicians. As Medable continues to expand its product portfolio, Vaish brings valuable expertise creating products that are intuitive and enjoyable, removing friction from the user experience. During his tenure as head of digital product at Tesla, Vaish led a team of 43, dramatically changing how people buy the Tesla Model 3 through advance deposits, paperless transactions, and personalized home delivery. His team also built a payment system for in-car upgrades. At StubHub, Vaish and team led development of the award-winning StubHub mobile app, featuring a personalized, seamless experience that enabled users to buy tickets in just three taps. At Epocrates, Vaish evolved its mobile app from a 1.0 forms-based product to a modern 2.0 experience to help doctors minimize drug-to-drug interaction dangers. You can read more about Parag joining Medable here.

January 2021 also marked Martin Luther King day. And with this special day in mind, we partnered with Allison Kalloo of the Medable Patient Advisory council to explore the very real disparities in diversity and inclusion in clinical trials. 

Allison was kind enough to share her visceral experiences of growing up and coming of age in the healthcare field dating back to her mom’s experience as a participant in the Civil Rights Movement and her subsequent career as a virologist focused on infectious diseases. This shaped Allison’s experience and led to her becoming one of the foremost thinkers in how to improve Diversity and Inclusion in clinical development. 

You can read Allison’s posts and watch her video interview with Dr. Michelle Longmire here:

 

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

Blog from Medable PAC member Allison Kalloo

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

Blog from Medable PAC member Allison Kalloo

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

Video interview with Michelle Longmire, Founder and CEO of Medable, and Medable PAC member Allison Kalloo

In the coming months Medable will be focusing on how to get started with a decentralized trial approach from both a strategic and operational perspective and then turn to looking at the benefits of launching a DCT platform that standardizes how systems, processes, people and data can come together in a predictable way to drive even greater efficiencies in this exciting new realm. 

Stay tuned!

Topics: decentralized trials remote trials PAC medable MLK eCOA
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