Medable advisory council works to amplify patient voice, inclusivity

Clinical research professionals increasingly are cognizant that achieving more patient-centric trials and increasing diversity in research are essential to effective results. Recently, Outsourcing-Pharma connected with two Medable representatives about the company’s efforts to step up patient experience and participant diversity, through initiatives like its Patient Advisory Council:

• Allison Kalloo--patient recruitment specialist, founder at Clinical Ambassador, iParticipate and CliniVIVRE (aimed at expanding minority access and impacting diversity, equity and inclusion in clinical research), and a new Patient Advisory Council member
• Reem Yunis, senior director of digital clinical science at Medable

OSP: Could you talk about the measures commonly taken to increase inclusion and diversity in clinical research?​

AK: The typical mechanisms used for broadening representation include selecting sites located in areas more densely populated by people of color, relying on referrals from physician databases, and reaching out to minority-focused community organizations, most notably, Black churches.

RY: Federal initiatives, such as the efforts of the NIH and FDA to require including demographic breakdown in clinical studies, are already in place. Any application for NIH funding, for example, for research proposals with clinical studies must include a table of enrollment target by race and sex. However, not meeting target enrollment does not affect release of funding or approvals of therapies. Sponsors and investigators are not held accountable for their shortcoming on diversity enrollment so it’s not surprising that diversity discrepancies continue to persist.

OSP: How might those measures fall short? What typically gets missed, or messed up?​

AK: These measures fall short because a) setting up a site in a location with a significant population of people of color does not translate into enrollees; b) physicians are an unreliable referral mechanism; and c) not all organizations want to work with researchers, even if a study addresses the healthcare needs of the community. The real problem is that these efforts are often deployed without any established relationships in place.

Barriers persist even in therapeutic areas where minorities are disproportionately affected. Diversity and inclusion suffer when exposure to clinical trials is scant, when the proper introductions have not been made, and when relatable, foundational information has not been shared with that community first.

Whether at the site level, the community level, or the protocol level, diversity shortfalls reflect enrollment processes being left to presumptions and chance. Fortunately, sound recruitment and retention measures are within reach — if planning takes shape early and includes the population the study needs to enroll. Don’t wait until you need rescue, don’t wait for regulations to require it, and remember that the best advice about how to reach people comes from those people.                   

RY: Lack of awareness by the research team and their eagerness to meet enrollment targets set forth by the sponsor to maintain a good standing relationship for future engagements is a major contributor to the diversity and inclusion problem.

The sponsor/CRO are working against the clock to enroll participants, as falling short of enrollment target is a well-documented problem. Thus, meeting overall enrollment as fast as possible is a priority over diversity enrollment.

Sponsors and research teams, unfortunately, do not consider a wider strategy of outreach to diverse communities in their study planning phase. Currently, social media campaigns are the go-to mechanism to widen enrollment to diverse communities but even with targeted campaigns, they fall short because of the historic distrust around clinical trials stemming from the infamous Tuskegee events.

OSP: Then, how does failure to ensure a fully inclusive, representational patient population lead to problems down the road, leading up to and including new-drug launches?​

AK: Failure to make studies appropriately representative has repercussions that negatively impact morbidity and mortality outcomes of minority communities. It has a direct impact on disease prevalence and on the future development and application of personalized/precision medicine. It also threatens the scientific integrity of studies across the board, leading to black box warnings and undermining the success of new-drug launches.

When compounds meant to treat conditions that affect minorities disproportionately spend years in the pipeline en route to commercialization but have inadequate inclusion of these populations in their clinical trials, the missed opportunities are substantial, and the implications are grave.

Medications are evidence-based only for those populations who participated in the studies that brought them to market. Period. Data is therefore missing on safety, efficacy, and appropriate dosages. Any unusual side effects occurring in special populations are also missed until they’ve been prescribed.

Further, promising interventions that may work better in certain subgroups can also fail to be identified and commercialized. All of these scenarios impact quality of life and prolong health disparities for minority communities, but they also negatively impact the bottom line in drug development.”   

RY: Lack of diversity in clinical research results in ineffective therapies in real-world practice. Many therapies used in clinical practice do not provide the same effectiveness reported in the study. In practice, patients are demographically diverse, their comorbidities vary, and their disease(s) can be clinically heterogeneous.

When clinical trials are completed on just a subset of the population, they miss that variability and consequently, the variability in response, which leads to suboptimal therapies in a real-world setting.”           

OSP: Why are inclusion/diversity advocates like you needed, and how do you help drive productive discussion and real change in the industry?​

AK: Advocates, provocateurs, and disruptors like me and Reem are essential. We exist to provoke change, push the limits, and challenge the status quo. But we could not do what we do if we could not see beyond the current fray into the promised land of what can be, and that also makes us eternal optimists.

Some of us are insiders who refuse to accept complacency within our organizations, and in other cases, we push and prod from the outside. Either way, though, change is inevitable.

RY: Diversity and inclusion are the world’s blueprint for success. As a geneticist, I like to say that diversity is in our DNA and evolution has promoted it to secure our survival as a species. Diversity in thinking, in approaches, in work also leads to innovation. In healthcare, it will result in better health outcomes for all, and fewer product failures in market.

OSP: Courtesy of your mom’s research work​, Allison, struggle with chronic health issues, discrimination in seeking care, and trial experience, you’ve got a unique perspective. Could you please share how her work and experiences impacted your family, and how it’s informed your own life’s work?​

AK: My childhood memories are joyous – full of laughter, art, music, travel, books. My mother is my hero. She dealt with a lot, but she had a dynamic, effervescent personality and friends all over the globe.

A scientist to her core, she was doggedly solution-oriented with intellectual curiosity both in and out of the laboratory. The fact that she forged a career in science in Washington, DC during the 1960s as a Black woman also speaks to her perseverance and moxie. 

Mom was my model disruptor and taught me to question everything. She, not my father, taught me how to drive a stick, change a flat tire, and fix minor household plumbing and electrical issues. She shielded us from her health struggles until it was impossible to hide. In everything, she exhibited remarkable grace, character, and a dedication to causes bigger than herself. Her example inspires everything I do.  

OSP: Could you please share some of the ways Medable seeks to help clients ensure they achieve inclusion and diversity in their studies?​

RY: Medable has developed a patient-centric decentralized clinical trials (DCT) platform, which enables remote clinical activities, including televisit, eConsent, and eCOA among others. DCT technologies increase accessibility by a larger and more diverse patient population by removing barriers to participation in clinical trials and lowering the burden on patients. They proved to be lifesaving during the height of COVID-19, and post-pandemic, will revolutionize how clinical research is conducted forever by making trial participation possible for all.

Medable also formed a diverse patient advisory committee, the PAC – of which, Allison Kalloo is a new member. The PAC brings the voice of patients and their unique perspectives to each product design and implementation.

Medable also launched the DEI committee, an employee-based initiative, which tackles diversity, equity, and inclusion issues both in our workplace and extends to the design of our products. It will ultimately improve patient accessibility and retention in trials – big challenges in drug development today.”                      

OSP: Allison, could you please talk about why you joined the Medable PAC, and what your goals are in the position?​

AK: When I was invited to join Medable’s PAC, I instantly saw the opportunity to bring diversity and inclusion awareness to yet another table. I enjoy exploring the many ways we can evolve industry accountability and solutions that patients can feel. I love working on these issues with this team of dedicated people from broad backgrounds.

OSP: Is there anything you’d like to add that we didn’t touch upon above that you’d like to share about trial inclusivity, patient-centricity, anything else?​

AK: Accountability, accessibility, and advocacy benefit all stakeholders. From their inception, clinical trial protocols should be designed with an open acknowledgment of disease prevalence and known disparities, and then focus on learning how best to achieve representative patient recruitment. Start with the end game first.