New PhRMA Guidelines Aim to Improve Clinical Trial Diversity

The Pharmaceutical Research Manufacturers of America (PhRMA) recently announced the release of industry-wide principles on clinical trial diversity.

The principles focus on four areas, including building trust and acknowledging the historic mistrust of clinical trials within Black and Brown communities and reducing barriers to clinical trial access.

Additionally, the principles aim to use real-world data to enhance information on diverse populations beyond product approval, as well as boost information regarding diversity and inclusion in clinical trial participation.

“The industry’s new clinical trial diversity principles are an important step toward greater health equity,” Stephen J. Ubl, president and chief executive officer of PhRMA, said in the announcement. “We are addressing issues of mistrust and working to reduce systemic issues that deter communities of color from participating in clinical trials, so that those patients who want to participate, can.” 

Diversifying clinical trials is crucial to provide information about drug response and measures of safety and efficacy to populations that have been historically under-represented and under-studied, PhRMA said.

Additionally, enhancing diversity in trial populations may also reduce healthcare disparities by increasing access to clinical trials. 

In addition to the four key principles, the guidelines also call on biopharmaceutical companies to also commit to: 

• Boosting education about the role of clinical trials throughout the medical community
• Increasing clinical trial awareness and diversity by improving health literacy and community outreach
• Adopting enrollment and retention practices that enhance inclusiveness and make trials less burdensome for participants 
• Broadening eligibility criteria to increase diversity enrollment 

A September Health Affairs study showed that Black patients were five times more likely to be hospitalized for severe COVID-19 than White patients and six times more likely to die from the virus.

Although CDC said that race  was a major risk factor for the coronavirus, early research on COVID-19 vaccine candidates mainly focused on White populations. 

Because of these major disparities, Black patients were less likely than their White counterparts to get a coronavirus vaccine if readily available and safe, according to an October Kaiser Family Foundation (KFF) report. 

Safety concerns (39 percent) and distrust (35 percent) were cited as the top reasons. But a majority of Black adults also had little to no confidence that the vaccine development process was taking the needs of Black people into account.

Health equality is critical for Black communities and clinical trial diversity better targets populations that require different medicine and therapeutic treatment options. 

PhRMA stated that adoption of these four industry-wide principles by member companies will help to address the systemic issues that dissuade people from participating in clinical trials.

“Enhancing diversity in clinical trial populations will lead to studies better reflecting the patient populations most likely to use the product under study if it achieves regulatory approval,” PhRMA said. 

“We strive to create a clinical development strategy representative of the intended population and encourage the inclusion of individuals from a diverse range of backgrounds including, but not limited to race, ethnicity, sex/gender, and age in clinical trials through broad eligibility criteria and novel site placement and recruitment approaches,” the company continued.

Generally, the objective of eligibility criteria to exclude individuals from clinical trials is to protect patient safety. 

But last week, FDA released final guidance to enhance the design and execution of clinical trials of drugs and biologics in order to encourage inclusivity. 

The guidance, Enhancing the Diversity of Clinical Trial Populations--Eligibility Criteria, Enrollment Practices, and Trial Designs, now includes both demographic characteristics of study populations, including sex, race, ethnicity, age, and location of residency, as well as non-demographic characteristics, such as patients with comorbid conditions or disabilities.

FDA stated that overall, sponsors should consider trial design approaches that will ensure a broader population. The approaches include characterizing drug metabolism across differing populations, establishing a broader pediatric development program, and including pharmacokinetic sampling to establish dosing in women who become pregnant during a trial.