A key requirement for clinical trials is to understand the effect of potential treatments on the patient populations that will benefit most. Despite this, many studies find diverse patient recruitment challenging and this can have major implications. In a recent webinar, our Founder and Chief Executive Officer, Kate Shaw, was joined by Jane Thurston, Senior Patient Recruitment Lead for Parexel, and Sandra Amaro, Global Clinical Trial Diversity Team Lead for Pfizer, to discuss the challenges of recruiting people from underrepresented communities and what can be done in practice to tackle this.
The pharmaceutical sector has struggled with the issue of diversity for several years. Initiatives to recruit more women, differently abled people and those from racially and ethnically diverse backgrounds into the industry are starting to make progress, but there is one area where a diversity gap remains – clinical trial patient recruitment.
Why patient diversity matters
Diversity in clinical trial patient recruitment matters. Without it, questions will remain over a potential treatment’s safety and accuracy regardless of how large the trial itself was. “We want patients in the trial that are representative of that disease,” Kate said. “If we’re not including everybody from diverse ethnicities, some ages, pregnancy status, once the drug actually is approved, we might find some adverse events are actually seen in patients who ultimately weren’t included in the trials. It could also have an effect on dosing.” Sandra Amaro from Pfizer agreed: “We recognise that in order for us to make better medicine that is fit for all, we need to recruit those that ultimately could benefit from those medicines once they’re available.”
Current barriers to achieving representation within clinical trials include:
- Differences in language and communication
- Attitude and beliefs
- Access to clinical trials
- Lack of knowledge about clinical research and what it entails
- Eligibility criteria
- Lack of trust in the therapeutic being investigated or in the medical and/or pharmaceutical industries as a whole
- Logistics
The impact of COVID-19 on clinical trials
Historically, public awareness of clinical trials has always been low. During the webinar, Kate estimated that only about one in 10 people know what a clinical trial is and what it involves.
However, we know that COVID-19 has helped shift the dial in regard to clinical trial awareness. The pandemic also forced the industry to rethink how trials are delivered and highlighted how important diversity in clinical trial patient recruitment is. “No one was essentially protected from COVID-19. However, our communities of color carried the highest-burden when it came to Covid and still do…so we need to make sure that there is representation in all of the clinical trials,” Sandra said.
The COVID-19 vaccine trials have subsequently been among the most ethnically and racially diverse we have seen. The result? Confidence that these vaccines are safe and effective for many different groups of people across the world. We must capitalize on this increased awareness of clinical trials and the lessons we, as an industry, have learned to support more inclusive clinical trials from now on.
Promoting inclusivity in clinical trials
Kate spoke about the importance of understanding the patient perspective to ensure inclusivity. For example, the nature of some conditions may make it more difficult for patients to attend early appointments. Childcare and transport costs can also have an impact. Jane Thurston from Parexel agreed. She said: “Many people forget that even in this day and age, not everyone has access to the internet or public forms of transportation…We have to meet patients where they actually are. They may not be in a medical center. You may have to go to a community center, a religious organization, or local barber shops.” Both Jane and Sandra discussed the commitment by Parexel and Pfizer to support greater diversity in clinical trial patient recruitment, and the ways in which they are redressing the balance. Solutions ranged from the decentralization of clinical trials to smaller, practical ideas such as prepaid debit cards to help people with transport costs.
However, while these ideas will help to retain participants in clinical trials, other tactics are needed to recruit them in the first place. Kate spoke about the need for comprehensive outreach – through online communities, patient advocacy groups, networking with healthcare professionals, and wider community engagement – to achieve a broad range of patients participating in clinical trials. Meanwhile, Jane from Parexel revealed how Innovative Trials’ Clinical Enrolment Managers provide invaluable support to increasing diversity. “We find that many times, sites don’t have the resources or bandwidth to do any community or physician outreach. So to provide diversity support service, we’ve been using Clinical Enrolment Managers, who are seasoned and knowledgeable, to be ‘boots on the ground’ for sites. This has truly been a game changer…”
All speakers acknowledged that increasing diversity in clinical trial patient recruitment is likely to mean more time and money required for studies, but that this is necessary to ensure treatments that are brought to market are safe and effective for everyone who needs them most. Otherwise, what’s the point?
Do you want to increase patient diversity in your clinical research? Download our free white paper for six ways to improve diversity in clinical trials.