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2 min read

Why I Joined Medable

By Dr Ingrid Oakley-Girvan on Dec 2, 2020 2:04:50 PM

Can you imagine waiting around in the kitchen for the phone to ring so you could do just one thing – talk to someone? Some of us remember when we had no choice because it was attached to the wall and we didn’t imagine all that a phone could be but then, that all changed. 

Smartphones untethered us and opened up incredible freedom with 3-D global video calls, digital maps and spoken directions, social and shopping apps, an embedded personal assistant, instant food delivery to our doors, endless internet searches no matter where we were, tagging and sharing of photos and information, calendars and health data at our fingertips, and so much more. 

This type of revolution is why I joined Medable.  When interviewing with the CEO Dr. Michelle Longmire and her co-founder Tim Smith, it was clear – we shared the goal of doing the same for clinical trials. Decentralizing operations, opening up freedom for patients and sites, creating digital therapies that could be delivered anywhere the patient chooses, enhancing robust remote data collection, cutting trial times in half, doing things so differently while maintaining scientific rigor – we were clearly aligned. In retrospect, I think when I joined many of my colleagues thought “wow, that is crazy, truly BHAGs, these guys are a bit nuts!” But now, as we watch vaccine development take place at an incredible pace and necessity forced regulations to facilitate Televisits and therapy development, our BHAGs hatched almost six years ago in the courtyard of a lively watering hole off Sand Hill Road don’t seem that nuts. In fact, they seem entirely achievable. 

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Our early recognition by NIH with two Small Business Innovation Research awards that I lead, work with multiple academic organizations and commercial customers to support their creative efforts to accelerate and provide better health care and trial experiences for patients and sites, and the belief in our goals and approach as documented by our recent $91 million in Series C funding bringing our total capital raised to over $136 million has been incredibly rewarding and validating.

As we work to continue to achieve our BHAGs this includes exquisite longitudinal ePRO, TeleCOA and digital data to help improve patient lives and deliver therapies in half the time, reduced paper and data burdens for sites, rigorous eSource and SaMD regulatory frameworks and metrics, delivery of interim endpoints and digital therapeutics, monitoring for early warning of simmering symptoms that warrant rapid clinical response and so much more all in a space where we re-envision the clinical trial experience. 

No two days in my life at Medable are the same with the exception of always being exciting and building on the team expertise and innovative mindset. I thrive off of being challenged to do more for patients and customers, creatively push harder, help solve disease disparities, and deliver validated solutions all while following our team ethos of Power Hour for self-care and Focused Fridays to thoroughly wrap up each week feeling I’ve made a difference and that my work is incredibly satisfying. The team spirit and energy is infectious and dynamic; we are empowered to have fun and move fast. If you are an expert in your area, hate being bored and share our BHAGs to do more for patients and help our clients deliver treatments sooner, I invite you to view our career opportunities.

Topics: decentralized trials remote trials careers life sciences
4 min read

A Visual Connection to drive Health Insights

By Dr. Reem Yunis on Nov 18, 2020 12:22:47 PM

The future is here.

For all its terrible consequences on humanity, COVID-19 has spurred a notoriously risk-averse life sciences industry to embrace a new clinical trial model along with the remote technologies that patients and clinicians have wanted for years. Today, researchers are suddenly conducting clinical outcome assessments (COAs) remotely through applications like Medable TeleCOA. Remote eCOA solutions and other technologies that allow a decentralized clinical trial model offer the potential to upend the current research paradigm.

According to a new PPD survey, nearly half (45%) of respondents cited eCOAs as having the most positive on trial performance. Also, remote eConsent (42%), televisits (41%), home healthcare (37%), direct-to- and direct-from-patient services (35%).

Of central importance is the potential for decentralized clinical trial (DCT) models and supporting solutions to enable a level of patient care and trial access that has never been possible before. Their adoption could close the clinical trial inequality and improve diversity. Telemedicine enabled eCOA solutions can open trial participation by enabling recruitment of patients who are no longer limited by proximity to the clinical site, an obstacle for recruiting minorities and people in lower socioeconomic environments.

Ironically, it’s a simple idea – by conducting patient assessments remotely, fewer in-person visits are needed. As a result, more rural patients, busy single-parent patients, and patients with less access to health care may be more willing to participate in trials that allow for more remote interactions with site teams.

TeleCOA can also eliminate healthcare burdens such as the stress of taking time off from work and lost wages, and long commutes to and from the site. A Harvard School of Medicine study, in fact, showed that an in-person doctor visit in the U.S. takes about 121 minutes – and only 20 minutes of that time is spent face-to-face with a doctor. This amounts to 1.1 billion wasted hours each year and $25 billion in lost productivity from employed adults!

Utilizing TeleCOA in clinical trials also has the potential to better capture the natural history of disease, and enhance recruitment and retention of patients with rare diseases by offering remote access to specialized medical care. For instance, a recent study was designed to test the utilization of Televisits and TeleCOA for patients with narcolepsy, a rare underdiagnosed disorder that requires a multidisciplinary approach for its diagnosis, monitoring, and management, allowing more patients to participate in the study. Remotely managing patients at their home eliminates the need to travel to seek consultation at the scarce number of sleep centers and allows a longer monitoring period compared to the limited one conducted at sleep center visits. It also provided a better understanding of the disorder within the patients’ natural environments for collection of richer real-world data.

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TeleCOA provides an extraordinary opportunity, too, to capture longitudinal data that allows for more precise and rapid assessment to changes in health. With this data, trial teams know more about how patients are doing in real time because visits are less likely to be missed (due to travel or work issues) and assessments can be done with greater frequency. More frequent assessments also provide better insight into interim outcomes and provide patients with that gold level of care.

Take, for example, cancer patients in the COVID-19 pandemic: concerned about their safety, many avoided office visits, impacting their performance assessments and, subsequently, their treatment plans. When clinics adopted televisit models, clinicians were able to conduct TeleCOA by remotely observing their patients and asking them to complete specific physical activities live and on-screen, allowing in-home clinical assessment of patient’s physical capability and better informing clinical decisions and treatment plans.

Having their clinic visit from the comfort of their home, patients are likely to be more relaxed and, as behavioral health literature suggests, more accurate data may be captured for some measures versus in-office visits when many patients experience high blood pressure (BP) due to the anxiety from the “white-coat” effect. White coat hypertension increases the risk for cardiovascular diseases and overall mortality as was found in a metanalysis by Cohen et al (2019).

Monitoring and recording BP at home between clinic visits is also becoming an integral part of a patient’s care management plan for many chronic diseases, and it must be correctly captured. In another example of better data capture and care, if there is a concern that an Alzheimer's drug may increase or decrease BP, a patient could easily be provided with a remote BP cuff and participate in more frequent assessments than would normally be done through office visits. In a TeleCOA visit, visual assessment of the BP measurement process could be observed and if the patient is improperly conducting the measurement such as incorrectly placing the BP cuff, standing up, or crossing their legs, this could be instantly addressed and fixed. Moreover, TeleCOAs might drive early insight into previously unexpected symptoms such as dehydration prompting doctors to offer rapid advice – improving patient care and preventing patients from dropping out of a trial unnecessarily.

Additionally, it is commonly understood that patients may provide a rosier picture of their health when meeting doctors in person and are reluctant to provide more sensitive data. TeleCOAs could reduce these effects and instead allow patients to feel more comfortable providing a more realistic picture of health concerns. For example, if early data suggests an oral chemotherapy may cause sexual dysfunction, patients might provide a true accounting of this information over a televisit but not in person. Regular longitudinal critical data could also reveal these early health concerns during a time period in which they can be easily addressed rather than when the situation is either acute or entrenched and then requires significant intervention or causes the patient to drop out of the trial.

It is impossible to know what the future still holds, but one thing is for certain – remote clinical trial technologies like TeleCOA have permanently changed how research is conducted. Now, regular clinical outcome assessments can be easily done from the comfort of the patient's home, which improves the quality of data captured to expand trial participation and indications. It enables a wholesale improvement on the patient experience, real potential for increased diversity in enrollment, increased trial efficiency, fewer trial dropouts, and ultimately shorter trial timelines. It’s a win, win, win, win.

Topics: remote trials RareDisease DCT TeleCOA
2 min read

Apple Watch and Research Kit May Accelerate Digital Endpoint Adoption

By David Swanger on Sep 16, 2020 4:49:14 PM

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Yesterday, the Washington Post recapped Apple’s fall product launch event:

Apple’s New Watch Draws Attention To Its Health-Care Play: Apple Watch takes the spotlight usually reserved for new iPhones at the September event

The article summarizes Apple’s shift toward services with a focus on the healthcare vertical, especially clinical research through Apple’s Research Kit:

“The Apple Watch is the physical manifestation of the company’s health-care play, and perhaps the most important but least understood prong of the company’s new business model anchored around services rather than gadget sales. The announcement also comes during the peak of a global pandemic in which the conversation about health and technology has accelerated.”

“Apple’s ResearchKit has been used for clinical trials, some of which it was announced to great fanfare. Last year, the company announced three major studies on women’s health, heart health and hearing. In terms of the massive amount of research constantly being conducted by drug companies and in academia, Apple isn’t much of a player.”

“In addition, ResearchKit isn’t a full-service offering. Companies that aim to use ResearchKit for trials still must have the resources to create customized software, and companies such as Thread Research and Medable have sprung up to meet that need. Large drug companies tend to opt for bespoke software with actual medical devices for traditional trials, industry experts say, rather than rely on ResearchKit.”

Medable views the collection of measurable data, direct from patients, in real-time as a key enabler of decentralized clinical trials and effective remote patient oversight. Being able to integrate data, such as ResearchKit, with other contextual data such as Patient Reported Outcomes, enables Medable to offer sites, patients and sponsors a modular suite of data in real time for actionable decisions and patient care management. Use of this data powers patient care initiatives that are now a part of the Medable Decentralized Trial Platform. These patient care initiatives range from enabling HIPAA-compliant workflows, interactions, and televisits between patients, doctors, and study managers using Apple, Android, and just about any mobile or desktop browser.

At Medable we are also excited to see Apple’s continued investment in utilizing the iWatch and iPhone to generate digital endpoints that perform as well or better as devices (like pulse oximeters) that are traditionally used at physician sites or medical labs. While the article notes that there is work to be done in ensuring that the veracity and reliability of these digital biomarker measurements meet or exceed traditional devices and measures, we at Medable are excited about the progress being made across the industry with digitally-enabled devices and measures.

The future is bright for bringing the clinical trial experience closer to a patient’s home and in the meantime helping to bring effective therapies to patients faster in our post pandemic world. If you’d like to learn more about Medable’s Decentralized Trial Platform, feel free to sign up for a demo.

 

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Topics: decentralized trials remote trials
3 min read

Zookeeper Living with Rare Disease Advocates for Change

By Medable Patient Advisory Council on Jul 23, 2020 10:54:11 AM

Being a zookeeper comes with a lot of surprises – late nights waiting for a rare birth, small animals displaying unexpected feats of strength, and watching a warm-weather animal loving the snow. However, there are some surprises that aren’t quite as fun, like learning the occupational hazard is acquiring a rare disease.

Michael Illig, now age 66 and living in an idyllic Oregon community, discovered he had sarcoidosis a few years ago. Sarcoidosis is a rare inflammatory disease that affects multiple organs in the body, but mostly the lungs and lymph glands. Abnormal masses or nodules (called granulomas) of inflamed tissue can form in certain organs of the body. One of the most common side effects is difficulty breathing – a symptom that would dramatically change Michael’s life as an outdoorsman who hikes nearly 200 miles a month in the lush green mountains near his home.

Like so many rare diseases, there is no cure. Some people walk around with sarcoidosis for years without ever becoming symptomatic while others experience massive organ failure. Michael’s own doctors call it a ‘mysterious’ disease. It typically manifests itself with shortness of breath, wheezing, chest pain, and persistent cough. Treatment often starts with corticosteroids to reduce inflammation followed by other medications such as methotrexate (Trexall) and azathioprine (Azasan, Imuran) that work by suppressing the immune system. Additional medications are used to treat specific symptoms.

Michael first experienced symptoms in his mid-40s when he was admitted to the hospitals with kidney stones but didn’t think much of it. It wasn’t until years later while hiking with his sister that he experienced severe chest discomfort and difficulty breathing. He was sick for weeks and finally went to the doctor when a CT scan found multiple nodules on his lungs. He was immediately prescribed the steroid prednisone, which helped, and then prescribed two inhaler treatments – a routine he continues today to relieve the heaviness in his chest.

Sarcoidosis, untreated, can lead to permanent scarring of the lungs, inflammation of the eyes, kidney stones and reduced kidney function, granulomas on the heart, and even nervous system problems.

Michael attributes the disease to environmental factors after decades of breathing in animal dander, feather particles, zoo cleaning aerosols, and other irritants but he is not bitter in the slightest. He reminisces fondly of his years working with numerous species of animals. Michael worked at various zoos, but spent the bulk of his career at the Oregon Zoo where he cared for hundreds of animals and worked from sun-up to sun down. He now advocates for improved safety measures for zookeepers today. “You used to have to wear a mask only when working with primates because they are biologically so similar to humans, but since COVID-19, zookeepers will need to start wearing protective masks when working with all animals,” said Michael. “That is long overdue.”

There are an estimated 150,000-200,000 people in the U.S. living with sarcoidosis, and while some don’t experience symptoms, others require medical treatment like Michael. Even so, Michael insists that nothing can stop him – and he may be right! Where Michael used to huff and puff walking up just slight hills, he now flies up 25-degree inclines with a 30-pound pack on his back, thanks to the dual-inhalant treatment regimen.

Michael is one of the ‘lucky’ ones living with a rare disease. Unfortunately, 300 to 400 million patients suffer from nearly 7,000 different rare diseases and 95% do not have a single FDA-approved drug treatment, leaving more than 30 million people in the U.S. with few to no options. There are many reasons for the lack of rare disease research – small patient populations, heterogeneous disease characteristics, lack of scientific knowledge, and absence of historical data – but one of the biggest hurdles is the prevailing clinical trial model that makes it difficult to recruit enough patients to generate statistically meaningful results.

The good news is that the technologies needed to improve patient access and trial experiences are here like Medable’s new mobile application called Trial-Fit TeleVisit which allows patients to connect virtually with research sites. These technologies, including wearables and site-facing apps, can overcome barriers to trial execution and improve data sharing and process efficiency across organizations conducting rare disease research. 

Another benefit of virtual or decentralized trials is that they provide more and higher quality data. Trial participants that track progress using a diary or recounting specific events that are pertinent to the trial at their next office visit create retrospective bias and inaccurate data capture. Decentralized trials enable patient reporting in real time for increased accuracy. For example, if the patient had an adverse event like a headache, she can capture the event at that specific moment while experiencing it. Patients can also capture a broader set of contextual data, such as their location when they had the episode or whether they were sleep deprived, hungry, or light-headed with digital tools. Researchers can use the contextual data to better understand the triggers around the adverse event. 

Decentralized trials allow researchers to continuously collect data about a treatment over time – this is particularly important with rare diseases since so little is known about their etiology, like with Michael’s sarcoidosis. Remote technologies including wearable devices, in conjunction with mobile health applications, can track symptoms automatically and without pause. 

Every six months, Michael takes a pulmonary function test that shows his oxygen exchange rate diminishing by just a point or two each time but he is feeling great. In fact, he says that he lost 30 pounds, is eating healthy, and happier than ever. We wish Michael – all those living with rare disease – good health and continued happiness. Thanks to decentralized clinical trial technologies, the future looks bright to discover life-altering new treatments for rare diseases.

 

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Topics: decentralized trials remote trials
3 min read

Mobilize and Decentralize

By Allison Holland- Head of Decentralized and Remote Trials on May 12, 2020 11:29:18 AM

Taking Action to Ensure Clinical Trial Progress During COVID-19

Why does it take so long to get new vaccines and medicines to market?

 

It is not a new question. But as governments, communities and medical professionals around the world focus their energy and resources on containing the COVID-19 pandemic, it’s being asked with increasing urgency. It deserves – in fact, it requires – our collective attention and effort.

The good news amidst so many troubling headlines is that the technologies we need to improve patient access and experience are here now. The smart application of those technologies can overcome barriers to trial execution and improve data sharing and process efficiency across organizations. Most urgently, those technologies can be used immediately to ensure progress for thousands of clinical trials in an environment where patients are expected to stay at home.

 

Decentralized and hybrid trials – the time has come

At a recent congressional hearing, NIAID director Anthony Fauci gave a frank assessment about the shortcomings of the U.S. system for coronavirus testing: It’s “not really geared to what we need right now.”

The same can be said for our traditional clinical trial model. Limiting trials to a handful or two of physical sites inherently limits patient access, while limiting interaction to in-person visits is not only grossly inefficient in many cases, but it also limits data frequency and quality. And during a crisis like the COVID-19 pandemic, it’s simply infeasible.

By contrast, decentralized clinical trials look more compelling than ever. The Clinical Trials Transformation Initiative (CTTI) defines decentralized trials as those trials executed through telemedicine and mobile/local healthcare providers, using procedures that vary from the traditional clinical trial model. In layperson terms, the trial is conducted remotely with the participant remaining at home.

The industry has been looking to decentralize trials for years. Now, as health authorities worldwide struggle to contain the COVID-19 outbreak, there is a renewed push to rapidly implement remote healthcare delivery capabilities.

There are currently more than 55,000 interventional clinical trials actively enrolling and providing care for participants worldwide. In light of the current outbreak, it is critical that we continue to deliver high-quality healthcare to research participants, while also continuing to advance clinical drug development programs.

Decentralized trials are largely “geared” for exactly this type of situation. Of the 55,000 trials in flight, some are good candidates for a fully decentralized model — while many others can be managed in a hybrid model. Patients can be recruited and consented remotely. Physician “visits” can be conducted remotely via telemedicine. Data can be captured remotely (and frequently) via medical devices and mobile technology.

All of this expands our ability to conduct research by “untethering” it from physical sites — critical when people around the world are being told to “stay home” due to the COVID-19 pandemic. It reduces the risk of pathogen exposure to research participants, while potentially accelerating drug and vaccine development.

Shifting to decentralized or hybrid trials often requires changes to study design or regulatory approvals. While that’s no small task, it’s an urgent one for many clinical trial leaders right now. We need to take collective action as an industry — including regulators — if we want to ensure productive client trial progress and avoid significant loss of patient participation.

 

Let’s mobilize

With all of this in mind, there is an immediate opportunity for decentralized and hybrid trials to help us through these challenging times, using digital and mobile technologies to improve patient access, experience and outcomes. Let's work together as a community to drive forward faster, whether it’s streamlining trials for COVID-19 vaccines, reducing timelines for other therapies, or initiating new trials to address the 7,000 rare diseases that have no therapies on the market.

 

The COVID-19 outbreak has made it crystal clear: Decentralized trials are no longer a nice-to-have. Reducing trial timelines has to be a long-term industry imperative, and digital technology can help valuable research continue to move forward while keeping participants safe. Let’s start now, and let’s move faster together.

 

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If you want to join us in this effort, please contact Covid19@medable.com or reach out to anyone on the Medable team at www.medable.com. We’re working closely with regulators, pharma sponsors, biotech sponsors, clinical research organizations and other tech companies worldwide in an effort to mobilize and accelerate decentralized trial adoption. We welcome everyone’s participation and feedback, and we look forward to working with you.

 

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Alison Holland is the head of decentralized and remote trials at Medable. Ali has more than 30 years of clinical trial experience, most recently as Global VP & General Manager for General Medicine at Covance, a leading global clinical research organization. Ali has managed more than 300 clinical trials, working successfully with biotech organizations as well as global pharma on some of their most critical initiatives.

 

Topics: telemedicine decentralized trials remote trials