Diversity in clinical trials requires a multifaceted approach
Clinical trial sponsors should implement multiple approaches to boost diversity in studies, from ensuring collected data reflect participant diversity, to working with a diverse group of investigatorsBy Feb 5, 2024 on
Addressing diversity in clinical trials is critical for long-term commercial success, as study data will be a stronger reflection of how the investigational drug will likely perform in the real world. Clinical trial diversity can also indicate what socio-economic barriers exist that may prevent patients from accessing the drug once approved.
- Diversity-related data collection improves the quality of analysis: Allows for a more complete picture of patient profiles, thereby ensuring the investigational drug’s safety and efficacy
- During the study design stage, it is important to engage and seek feedback from patients and the wider community: To understand their needs and increase awareness. Clinical trial locations should be strategically located to bolster diversity
- Technology can assist with increasing diversity in studies: Service providers can provide advice on how technology can help lift diversity barriers
Diversity in clinical trials is receiving increased attention as it ensures that studies will better reflect real-world conditions. Diversity is key to testing if an investigational drug can meet a patient’s medical needs and that the drug’s performance would not be affected by socioeconomic factors.
Johnson & Johnson has a three-step approach to boosting participant diversity in its clinical trials. These steps focus on data collection, investigator diversity, and community engagement.
For richer analysis, the primary step is to ensure that data collection practices reflect diversity. When collecting data, information about race, ethnicity and geographic diversity should be included. This information is key to understanding the epidemiology of the disease, which is just as important as an investigational drug’s safety and efficacy profile.
To boost participant diversity in clinical trials, investigators should also be diverse. Investigators who reflect and understand the communities they serve are better equipped to engage with potential study participants, which in turn improves recruitment and retention rates.
The third step is community engagement. Gathering early feedback from the patient community on different elements of the trial – including the design, recruitment approach, and eligibility criteria – is crucial during the design process. The trial’s inclusion and exclusion criteria should allow leeway for comorbidities seen in everyday patients as these issues can exclude them from clinical trials. To allow more diverse voices to be heard, pharma companies should stage virtual meetings.
Thoughtful trial site selection is key to increasing patient awareness and reducing access barriers. Location choice is critical as it can influence the type of data collected. If a trial was to be staged in Scandinavian countries, for instance, collected data would not represent the racial diversity in the US.
Technology can be a tool to bolster diversity. Technology service providers can help pharma companies select digital approaches that would maximize diversity in trials. When implementing technology in studies, pharma companies should solicit feedback from a variety of stakeholders (such as patients and academic institutions) to ensure the technology meets needs and standards. Diversity of thought from relevant stakeholders will enable better use of technology to decentralize clinical trials.
Clinical trial sponsors should find ways to lift barriers to using digital devices. Some communities may not have access to certain technologies – such as reliable internet reception, and access to computers or smartphones – which can impact diversity in studies. When choosing auxiliary materials, such as medical devices used to administer drugs, it should be with diversity in mind to not interfere with participation.
Cloud-based systems have the potential to boost geographical, socioeconomic, and epidemiological diversity in clinical trials. Nonetheless, the study platform should be device and cloud-agnostic. In patients who are unable to use certain technologies directly, the digital approach should be adapted to their needs; caregivers could function as a proxy. In hard-to-reach areas, call centers can be used to interact with patients remotely.
Industry Experts Who Contributed:
All contributors are senior leaders within the pharmaceutical industry
- Jasna Tholens, Global Director Clinical Trial Management, Johnson & Johnson
- LaShell Robinson, Director, Diversity, and Inclusion in Clinical Trials, Takeda Pharmaceutical
- Michael Zaiac, Head of Medical Affairs Oncology for Europe, Novartis
- Dr Mert Aral, CMO, Hume
- Moderator: Craig Lipset, Advisor, and Founder, Clinical Innovation Partners
See the full webinar here.