New from PhRMA: Diversity in clinical trials — principles summarised
The Pharmaceutical Research and Manufacturers of America (PhRMA) recognise that achieving diversity in clinical trials is an ongoing challenge, just like we do. And the good news is, they have taken action to address the challenge.
In November 2020, PhRMA announced the first-ever, industry-wide principles on clinical trial diversity. The principles were approved by the PhRMA Boards of Directors and will take effect in April 2021.
A new chapter for diversity in clinical trials
PhRMA have taken the existing principles a step further by adding a new chapter — Commitment to Enhancing Diversity in Clinical Trial Participation.
What does the addition of this chapter mean? Well, these new principles will enable PhRMA members to stay committed to their goal of improving diversity:
“It is with these core principles in mind that we commit to continuing to work with patients, patient advocacy groups, regulatory authorities, healthcare practitioners, academics, and policymakers to define the systematic and impactful approaches that we will take to enhance the diversity of clinical trial participants and help reduce healthcare disparities.”
The finer details of the PhRMA diversity in clinical trials principles
The new principles focus on four main areas. Each of these areas aim to address the different barriers that lead to lack of diversity and inclusion, provide examples of how PhRMA will be committed to tackling the issue, and include guidance for biopharma companies who choose to adopt these principles. So, let’s take a closer look.
1. Building trust and acknowledging past wrongs
The PhRMA principles begin by explaining the reasoning behind mistrust throughout communities, and how this can lead to lack of clinical trial participation. More specifically, they highlight the historic mistrust of clinical trials within Black and Brown communities. To address this, PhRMA will be committed to:
a. Enhancing education and diversity among clinical investigators
They will conduct outreach to the medical community in communities that have been underserved, and support trial sites with comprehensive education on medical product development. They will do this in a culturally competent manner and will be developed in partnership with the communities they seek to serve. They will also seek to further encourage the recruitment and retention of clinical trial personnel with diverse backgrounds, as a pool of diverse investigators can serve as a trusted and knowledgeable source of information for underrepresented diverse populations.
b. Increasing clinical trial awareness and diversity by improving individual health literacy and community outreach
When conducting clinical trials, PhRMA are committed to using approaches that address all health literacy backgrounds and different levels of clinical trial awareness. They also commit to conduct community outreach, such as partnering with health and community advocacy groups, to increase clinical trial awareness and potential opportunities for participation.
2. Reducing barriers to clinical trial access
PhRMA highlights that biopharmaceutical companies who are following these principles should employ strategies and encourage use of practices which are meant to reduce the barriers to participation, by:
a. Adopting enrolment and retention practices that enhance inclusiveness and make trial participation less burdensome for participants
For example, identifying sites where diverse patients with a particular disease or condition may be located, identifying healthcare providers that treat underserved orunderrepresented populations, and collaborating with investigators to address the goals of enrolling a diverse population in a clinical trial. Plus, sponsors should consider recruitment challenges and enrolment barriers that may occur as a result of factors such as planned visit schedules, location, financial implications, and how these might be addressed.
b. Considering the needs of diverse populations in clinical trial design
PhRMA reinforces the importance of using a patient-centred approach. For example, incorporating the patient perspective and considering burden on patients’ and caregivers’ lives, and addressing these at the design stage. Inclusive study protocols should be developed by closely involving people from Black and Brown and other underrepresented groups, including patients, patient advocates, and caregivers.
c. Broadening eligibility criteria when appropriate
PhRMA commit to adopting practices that will help to determine study eligibility criteria and reflect the diversity of patients who will use the drug if approved. They do this by using: information on populations who are at risk for a particular disease, data from earlier trials, the therapy’s mechanism of action, any available post-approval data, and/or real-world evidence to enhance understanding of the heterogeneity of treatment effect, or lack thereof, for selected subgroups. This information should allow medical product development programs to broaden the inclusion and exclusion criteria and improve diversity in the trial populations.
3. Using real-word data to enhance information on diverse populations beyond product approval
The principles highlight that collecting clinical real-world data during the post-approval phase, in compliance with local laws and regulations, may serve as an effective and efficient means to enhancing understanding of drug effects in diverse patient populations.
4. Enhancing information about diversity in clinical trial participation
Finally, PhRMA encourages biopharma companies who choose to adopt these principles to establish policies or practices that address the previous points outlined in this chapter. The policies should be specifically focused on enhancing diversity of clinical trial populations. They also suggest that companies could post materials that describe the efforts they are making to enhance diversity, based on these principles.
There’s still a long way to go to truly improve diversity in clinical trial populations. But it’s great to see that organisations such as PhRMA are taking a step in the right direction towards positive change and this comes hot off the heels of the FDA guidance launched in November 2020.