Why diversity matters in clinical trials

When developing new medicines and therapeutic interventions, it is important to ask: "for whom are these medical innovations effective?" 

To answer that question, the safety and efficacy of novel interventions needs to be demonstrated among the entire population, as there is compelling evidence that the response to medication and treatment varies between different subgroups¹. Although the need for inclusion of all demographics such as gender, age, race, socioeconomic status and geography in clinical research has been recognized for over 20 years², large proportions of the population including women, ethnic minorities and people living in remote areas are still underrepresented in clinical trials. Furthermore, for a long time drug sponsors have presented limited data to enable the analysis on specific subgroups in their clinical trials³.

In the last decade more attention has been paid to enhance diversity in clinical trials. In the US, recent studies have shown that the inclusion of minorities differs highly from one trial to the other and even today at most 56% of all clinical trials reach consensus levels for African Americans and Hispanics while less than 16% reached census levels for Asian Americans and other minorities, with some trials not having any representation of these subgroups at all⁴. In addition, women are still underrepresented in clinical trials, including those for novel cancer therapies⁵. Underrepresentation of women may have important biological, and thereby clinical, implications as sex hormones are known to affect tumor growth, immune response and gut microbiome. As a result, disease progression and response to treatment differ between men and women, and therefore inclusion of women in clinical trials is of the utmost importance to improve treatment outcomes.

The lack of diversity is not related exclusively to ethnicity or gender. Also practical aspects pose major barriers including financial constraints due to the need to take unpaid leave from work, requirement of childcare when parents participate in clinical trials and translation of the study materials in the native language. In addition, more than 70% of potential clinical trial participants live more than 2 hours away from the study site, which leads to underrepresentation of people in remote areas⁷. These issues can be addressed by bringing study sites closer to the patient and the enhanced use of virtual technology to reduce the need to travel for the patient.

In order to enhance the quality of care for all patients, it is essential to take diversity into account from the very beginning, starting with the design of clinical studies. Due to the Covid-19 pandemic, the use of decentralized clinical trials (DCT) has increased tremendously from 28% to more than 76%. DCTs may aid in enhancing the level of diversity in clinical research as the trial will be conducted partially or completely virtual and the patients can be treated primarily at their homes. In addition, sites can be placed strategically in the vicinity of patients, instead of finding patients around the site. As such, geographic barriers will be lowered since patients do not need to travel to study sites any longer. Furthermore, the impact of socioeconomic barriers will be reduced since the number of clinical visits as well as traveling time can be reduced. Altogether, by removing barriers, DCT widens the participant pool and thereby enhances diversity.

At PatchAi we embrace diversity and our solutions aid in conducting clinical trials among a diverse population. We aim to engage our patients, no matter who they are or where they are from, every step of the way. Want to learn more? Click here.

 

1 Stronks et al., Trials, 2013 DOI: 10.1186/1745-6215-14-177  

2 NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research. 1994;59(Part VIII):14508–14513

3 Mak et al., Adm Policy Ment Health, 2007 DOI: 10.1007/s10488-007-0133-z

4 Rottas et al., Contemporary Clinical Trials, 2021 DOI: 10.1016/j.cct.2021.106421 

5 Mendes et al., The Oncologist, 2021 DOI: 10.1002/ONCO.13534

6 Digital R&D, Transforming the future of clinical development https://www2.deloitte.com/us/en/insights/industry/life-sciences/digital-research-and-development-clinical-strategy.html