Clinical trial diversity has been one of the most pressing needs in the healthcare industry for decades. For this and many other reasons, the Biotechnology Innovation Organization (BIO) created their BIOEquality Agenda, “a national effort in collaboration with our partners and member organizations in the biotechnology sector that aims to counteract the systemic inequality, injustice, and unfair treatment of underserved communities.”
The agenda’s three-pronged approach—which includes promoting health equity, investing in the current and next generation of scientists, and expanding opportunity for women and other underrepresented populations—recently took another step forward with the unveiling of the new Clinical Trials: The Power of Participation (CTPoP) website, as well as the recent white paper, “Improving Diversity, Equity, and Inclusion in Clinical Trials.”
The website and the white paper tackle the issue of clinical trial diversity in a holistic way to discuss the struggles associated with clinical trial diversity, develop solutions, and share resources.
“When clinical trials are diversified, everyone’s health improves,” says BIO’s board chair, Ted Love. “The culmination of the white paper and the guidance that will be available on the new CTPoP website will give patients the tools they need to get access to the clinical trials that might be the very thing they need to save their life.”
Collaboration for creation and lasting change
A product of BIO’s roundtable discussion on clinical trial diversity in January 2023, the white paper, “Improving Diversity, Equity, and Inclusion in Clinical Trials,” was created to address “the need to reduce barriers to patient care through collaborative efforts and broad alignment among stakeholders, recognizing that no single entity can achieve this on its own,” as the white paper’s executive summary explained.
“It is a call to action to take forward-leaning strides toward embracing insights gained from the roundtable, thereby advancing diversity in clinical trials,” continued the white paper’s executive summary.
During their roundtable, attendees observed the need for “a simple, yet effective approach involving patient-centered, physician-oriented, and system and policy-related change… essential for addressing disparity and inequity within this space” that “explored how solutions such as enhancing patient-family education, expanding peer-to-peer educational initiatives, promoting effective communication techniques to decrease barriers and foster trust, enforcing industry to engage patient advocacy organizations to better understand overall patient preferences, and support programs to facilitate greater engagement and participation from underrepresented populations.”
This is where the effectiveness of the collaboration in the roundtable really shone. It was not just a group from one area that was defining and dictating the goals, approach, and development of solutions, it was a group of people sitting at different points along the healthcare spectrum. Patient advocates and physicians were sitting around the table with the industry leaders and government officials (among others) who could respond to their ideas, answer questions, and point out flaws, and vice versa.
For example, “FDA representatives discussed their efforts in the areas of minority health and health equity, protecting and promoting the health of diverse populations. FDA’s Center for Drug Evaluation and Research (CDER) expressed its commitment to increasing involvement of underrepresented populations in clinical trials through the establishment of the Diversity Plan Implementation Committee (DPIC), in addition to issuing guidelines such as Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”
Similarly, “One panelist introduced a framework developed to quantify accountability and transparency,” the white paper explained.
“The discussion also included viewpoints from industry on inclusive research tactics aimed at improving patient diversity through a multi-channel approach.”
Approaches such as “expanding site locations, optimizing communication, and enhancing data collection and utilization,” as well as “better planning to adjust programs and community engagement includes optimizing early-stage design, analyzing patient cohorts, incorporating patient voices, identifying suitable countries and sites, and incorporating site feedback” were all explored, discussed, and fleshed out.
The roundtable soon realized a common breakthrough of thought: “there is no patient diversity without site diversity.” To reach patients, the healthcare industry has to meet them where they are at, both figuratively and literally. To do that, patient education needs to be a high priority.
Putting the power in patients’ hands
Where the development of the white paper aims to help healthcare leaders overcome barriers to clinical trial diversity on the policy and industry side, the new CTPoP website aims to answer questions from the patient side of things. As stated on the website, CTPoP “is designed to answer your questions about clinical trials,” including, “information on everything from how clinical trials work to where to join.”
Putting the power of clinical trials in the hands of patients, the website both defines what clinical trials are, and offers resources on why it is important for patients across the board to join clinical trials where needed, stating, “This will ensure that new medicines and treatments work for everyone.”
The website also helps patients learn what to ask their doctors when it comes to exploring the option of clinical trials, as well as understanding the many steps associated with participating in a clinical trial.
For example, the website explains to users the difference between the four stages of a clinical trial. From phase 1, in which researchers test a new drug or treatment in a small group of usually healthy people, all the way to phase 4, “when longer-term studies, conducted after medicine is approved, provide additional information on a drug or treatment’s risks, benefits, and best use.
More importantly, the website also offers a comprehensive series of directories on how to find a clinical trial through well-developed resources such as TrueTrials and BlackDoctors.Org (BDO), among others, all which list both specific and general clinical trials and patients can explore participating in.
“Kudos to BIO for their vision and commitment regarding Clinical Trial diversity,” said Reggie Ware, CEO of BDO. “BIO understands that the timing is perfect to engage Black consumers on a deeper level when it comes to Clinical Trials. Our audience is ready to hear and learn more. As a result, our BIO partnership is proving that when you meet the demand where it is, you can have meaningful impact and results.
“I am looking forward to continuing this incredibly important and thoughtful partnership,” Ware concluded.