No One Left Behind: Our Vision of Clinical Trial Accessibility

I’d like to take a moment to shine a humanistic light on clinical research.

Good Clinical Practice sets clear standards to protect the “rights, safety and well-being of trial subjects” and ensure data quality. But the description as “trial subjects” misses the human element from the people participating in clinical research. They are mothers, fathers, sisters, brothers, sons and daughters…. Their lives and that of their families may be altered, most likely more difficult, because of their illness. Participating in a clinical trial may improve their quality of life, possibly even prolonging life.

Now, let’s put a “face” to the people who seek out clinical research. If we looked at participants in clinical trials today, we would see that they generally don’t represent society, either in the composition of ethnicity or gender. And more concerning, the patients don’t necessarily represent the intended beneficiaries for the treatment being investigated.

What if we consider other characteristics of the people who could participate in clinical trials? For example, what is their level of education? What is the literacy rate? How many are hourly wage earners who don’t receive sick pay? How many have adequate – if any – medical insurance? How many live in rural or remote areas with limited medical facilities?

If we looked at participants in clinical trials today, we would see that they generally don’t represent society, either in the composition of ethnicity or gender.

It is against this backdrop that we ask: how can clinical trials be more accessible to more people? This led to our recent webinar "No One Left Behind: Addressing Clinical Trial Access and Issues Blocking Physician Participation.”

We oriented this session from the perspective that making clinical trials more accessible to more physicians opens opportunities to build awareness and trust among a broader patient population.

In perhaps the most engaging – and entertaining – panel discussion of my career, I had the privilege to moderate a discussion with a distinguished group:

• Ken Getz of the Tufts Center for the Study of Drug Development (CSDD), who is a leading industry expert in clinical research trends
• Cassandra Smith of Janssen R&D, who is a thought leader in clinical trial diversity and inclusion
• Brendan Buckley, Teckro Chief Medical Officer, who is an advocate for the site perspective as an investigator/physician himself

I won’t give everything away, but here are a few highlights of each presenter:

• Cassandra presented the case for more awareness of racial diversity in clinical trials, citing research that indicates Blacks, Asians and Latinos are underrepresented in clinical trials, making up only 24% of the participants in key clinical trials over the span of a decade.
• Drawing on a wealth of Tufts CSDD research, Ken painted a picture of the increased complexity of clinical trials, with 86% more endpoints and 183% increase in overall protocol data over the last 10 years.
• And Brendan shared his perspectives on the ethical considerations, as well as the scientific perspective that a more diverse population will improve research on how different ethnic groups may react to a given treatment.

The panelists then debated a few topics in a free-form discussion:

• How does improving access to trials increase diversity?
• How can sponsors manage the potential risk associated with new research sites and/or new investigators?
• Given protocol complexities, how can we reduce the burden on investigative sites?
• How can research staff and investigators get away from referring to paper copies of the protocol or PDFs locked on their desktop computers?
• What will the impact of COVID-19 be on future protocol execution?

As part of Teckro’s ongoing focus on clinical trial accessibility, we sponsored this webinar as a way to be a champion for those who can’t be champions for themselves. With heightened awareness of clinical research and the disproportionate impacts of COVID-19 on minority populations, now is as good a time as any for the industry to take a new approach to clinical trial participation.

Kelly Brown

Guest