Pfizer’s Call for Clinical Trial Diversity: But How do We Get There?

Pfizer’s Call for Clinical Trial Diversity But How do We Get There

American Pharmaceutical company Pfizer has recently published a call to action to diversify clinical trials participation.  They are addressing so-called “underrepresented” populations, ranging from communities of color to the elderly, rural populations, or other socioeconomic categories negatively correlating with clinical trial participation. Clinical trials are incredibly important: they represent a fundamental basis for the founding of TrialSite News and the media platform’s mission to help bring more transparency, and associated accessibility to research, to more people around the world. That requires trust, which necessitates as much objectivity as humanly possible. It’s working; our traffic has grown in such a short time and will approach 1 million per month sometime in 2020. But that’s just the start. As Pfizer identifies, distrust runs deep and often is associated with health systems themselves. Socioeconomic and cultural forces interplay to influence social and health care outcomes: hence the emergence of social determinants of health as a broad-based conversation.

Why is Diversity Needed in Clinical Trials?

Because the development of new drugs and therapies may impact different people in varying and differing ways. If in the research and testing process this isn’t identified and figured out, then those that didn’t participate are essentially left out of the process of the production of medicine. The COVID-19 pandemic is just the latest of examples as certain groups have been far harder hit than others. It isn’t rocket science to understand that the social determinants of health greatly impact outcomes in this pandemic. And the outcomes aren’t fair, equitable or even—those already struggling will only struggle more.

Tens of millions of Americans (hundreds of millions to billions worldwide) don’t have access to regular health care, and an emerging clinical research as a care movement can change that by intelligently matching trials to specific patient need and, in doing so, ensure more people receive health care while in parallel improve quality and extend life spans where and when possible. All people deserve access to good health care. Clinical trials aren’t a panacea for an important set of activities and a tool set as part of a more holistic and comprehensive health care strategy in the pursuit of health care for all.

According to Rod MacKenzie, Chief Development Officer with Pfizer, “Ensuring diversity in clinical trials is a matter of equity. We’ve made a commitment to design clinical trials so that enrollment can reflect the racial and ethnic diversity of the countries where we conduct clinical trials and the epidemiology of the diseases we intend to treat or prevent.”

African Americans and Research Distrust—Latinx Just not Participating

Pfizer addresses this unique challenge in the American healthcare system, noting, “Many in the Black community still remember the syphilis study conducted with Black men in Tuskegee, Alabama. The study ended 50 years ago, but the sentiments of betrayal and exploitation felt by many remains to this day.”

Pfizer highlights the fact that although 13% of 330 million Americans are identified as Black, only about 5% of clinical trial participation is so. The disparity is even more pronounced for Latinx (nearly 20% of the population now and only 1% of trial participation). That one of the largest ethnic populations in the United States barely even shows indicates serious disconnect between the interplay of health systems, pharmaceutical companies, and communities and consumers themselves.

Systemic Underlying Challenges

Pfizer should be commended for taking such a direct stance. But the problems can’t be solved by pharmaceutical companies, although they can contribute to solutions. Although the fact that institutional review boards (IRB)s today ensure studies are conducted in a safe and ethical way, this hasn’t changed a basic fact that tens of millions of Americans don’t really trust big health care systems, government or pharmaceutical companies for that matter. The reasons for the lack of trust are complex, myriad and endemic and beyond the scope of this piece. But suffice to say: with vision, direction, leadership, and action, positive transformation is not only possible but feasible.

TrialSite News’ Take

Some of TrialSite’s principals have extensive experience in patient recruitment. In fact, one of the media platform’s founders spent time working for the largest patient recruitment company in the United States during that time. It was acquired by a large holding company. TrialSite observes that social media engagement opportunities aside, many of the same factors and forces relevant twenty years ago are in full effect today. Single campaigns and one-off initiatives won’t work. Rather, more systematic transformation of the health system itself must be the answer. TrialSite’s African American Clinical Research Disparity Survey raises just some of the systemic considerations.

Presenting on the TrialSite Podcast, Dr. Jayne Morgan, Director of Innovation at the prominent Piedmont Healthcare, presented some of the challenges and obstacles to equity in clinical research.

Progress is possible and some answers to these questions exist, at least partially, in programs today. SWOG reported that publicly financed clinical trials recruit more African Americans than industry-sponsored ones. Yale’s Cultural Ambassador program yields greater participation from both African Americans and Hispanics in New Haven Connecticut. 

Bristol Myers Squibb is working to raise the bar for involving minority and unrepresented populations with a commitment of $300 million to start more systematically addressing inequities in healthcare.

And many more initiatives are ongoing and unfolding around the country, and world.

Its Comes Back to Basics

A foundational societal commitment to health care access for all underlines a multifaceted strategy for participation in research.  Access to healthcare in the United States has declined since the pandemic as many companies have either cut back or even gone under.  Most new jobs in the U.S. are with small companies—this is how a majority would gain back access to health—that or Medicaid and Medicare. 

Many small businesses don’t have the financial wherewithal to offer health coverage, especially given the expense of today’s health insurance products. Medicaid programs change from state to state. Calls for pure “free market” reform are more fantasy than reality, given the legal framework for health insurance—with it being regulated on a state-by-state basis. For Americans, it’s a wake up call to all people that there must be seamless and efficient access to basic, high-quality health care; with rationale and sound direction and the use of  technology as well as disruptive process and workflow, intelligence can be infused into the system so that those accessing health care programs can be paired with the appropriate research for research as care options.  

In general, higher levels of trust will increase research participation, especially if the local providers, embedded in communities, do the patient to study matching. Many of the building blocks, technologies and processes exist to make this happen, they just haven’t been brought together in a cohesive and compelling way. That takes political vision and leadership, which unfortunately is in short supply across the board.