Race, ethnicity, age, and sex can all impact how different people respond to the same medicine or vaccine. This is why diversity among clinical trial participants is so important. The more diverse a group of clinical trial participants, the more we can learn about the safety and efficacy of a potential medicine or vaccine for people who have characteristics like those of the participants.
When individuals choose to participate in a clinical trial, they will represent people like themselves and from their local communities — in age, race, ethnicity, and gender. Participation in clinical trials by people of all backgrounds can make a difference by reducing health disparities among underrepresented populations and improving the development of medicines and vaccines for everyone.
Historically, some communities have been underrepresented as participants in clinical research. There are barriers that exist to clinical trial participation. As part of the healthcare community, we must work to expand access to clinical trials by lowering barriers that may have stood in the way of more inclusive participation. Some of these barriers may include:
Lack of trust in the medical community due to discrimination and mistreatment of ethnically diverse groups in clinical research throughout history.
Financial challenges that might come with a lack of, or inadequate, health insurance, study-related travel expenses, or the time commitment a clinical trial might require.
Lack of awareness of clinical trials because the trials are not available in all areas, people may not be given information about trials, and there may be language and cultural barriers.
Overcoming these barriers won’t happen overnight. But we know the work that must be done. As clinical research sponsors, we are committed to doing our part to help take down as many barriers as we can.
Protections for clinical trial participants
Historic mistreatment and human rights violations in research throughout the world have inspired changes in the law to ensure that clinical trials are conducted ethically and participants come first. Today, all clinical trials must follow Good Clinical Practice, an international ethical and scientific quality standard for designing and conducting clinical trials.
As part of Good Clinical Practice, institutional review boards (IRBs) or independent ethics committees (IECs) oversee clinical trials, with a focus on protecting the participants’ rights, safety, and well-being. An IRB or IEC is an independent group that:
- includes scientists, doctors, and lay people.
- reviews a clinical trial’s design and any updates to it, as well as any information provided to participants.
- has the authority to approve, ask for changes, or disapprove clinical research.
IRBs and IECs also review a clinical trial’s informed consent process. During informed consent, prospective participants are given all details about the study they are considering, including the potential risks and benefits. They can ask any questions they have before deciding whether they would like to participate.
Our commitment to equity in clinical research
At Pfizer, we are committed to creating change for the better by doing our part to make a more inclusive future for clinical research and by building trust within diverse communities. 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. Pfizer is committed to addressing both informational and practical barriers to clinical trial participation.
Ensuring diversity in clinical trials is a matter of equity. Everyone deserves a chance to raise their hand and participate, contribute, and ultimately benefit patients in their communities.