Letter from the editor: Diversity and inclusion in clinical trials

Abstract

In this issue of the Journal of the American Academy of Dermatology, Enos et al report similar responses to biologic therapy across racial and ethnic groups among patients with psoriasis enrolled in the CorEvitas Psoriasis Registry. Studies of this type are essential to determine the safety and efficacy of medications in various populations. The inclusion of women, pediatric, and minority populations in clinical trials is critical to judge responses and outcomes in these groups. However, the attempts to improve representation in clinical trials have had varied results, and large gaps remain.1Kwiatkowski K. Coe K. Bailar J.C. Swanson G.M. Inclusion of minorities and women in cancer clinical trials, a decade later: have we improved?.Cancer. 2013; 119: 2956-2963Crossref PubMed Scopus (99) Google Scholar, 2Gore S.M. Inclusion of women and minorities in clinical trials.Control Clin Trials. 1995; 16: 290-292Abstract Full Text PDF PubMed Scopus (8) Google Scholar, 3Oyer RA, Hurley P, Boehmer L, et al. Increasing racial and ethnic diversity in cancer clinical trials: an American Society of Clinical Oncology and Association of Community Cancer Centers joint research statement. J Clin Oncol. Published online May 19, 2022. https://doi.org/10.1200/JCO.22.00754Google Scholar Proactive measures are needed, and subgroup analysis must be carefully planned in advance to avoid the loss of important signals in a larger population and bias introduced by unplanned post hoc analysis. There are many factors contributing to the lack of diversity in clinical trials. Populations enrolled in trials may relate to disease prevalence, willingness to enroll, office location, and global geographic location of trials. However, the quality of science and generalizability of results depends on the inclusion of study participants who represent all populations among whom the treatment and prevention approaches will be used. Efficacy and risks in specific populations cannot be assessed unless they are included in clinical trials, and subgroup analysis is planned prospectively and performed with care. An ongoing issue is the lack of reporting of underrepresented populations in clinical trials.4Rees C.A. Stewart A.M. Mehta S. et al.Reporting of participant race and ethnicity in published US pediatric clinical trials from 2011 to 2020.JAMA Pediatr. 2022; 176e220142Crossref Scopus (4) Google Scholar In the absence of data, it is difficult to accurately assess the current status or judge improvement. Various groups have published recommendations aimed at increasing diversity in clinical trials. Some of these recommendations include the collection of accurate data on the racial and ethnic diversity of trial participants; allowing every person with a given disease the opportunity to participate; reducing barriers to participation during the design and implementation of clinical trials; formation of partnerships with patient advocacy groups and community leaders to promote participation; recurring education, training, and evaluation to maintain cross-cultural competencies and mitigate bias; decentralization of clinical trials to encourage broader participation; and addressing the complexities of language barriers, at-home medication delivery, and transportation. There are ethical issues related to the intentional or unintentional exclusion of populations.5Taylor H.A. Inclusion of women, minorities, and children in clinical trials: opinions of research ethics board administrators.J Empir Res Hum Res Ethics. 2009; 4: 65-73Crossref PubMed Scopus (13) Google Scholar Additional questions of safety, autonomy, and consent arise when treatment of pregnant women and children is considered. Unintended consequences of interventions must also be considered because attempts to improve a single element of inclusion have resulted in unintended outcomes in other elements.6Goodson N. Wicks P. Morgan J. Hashem L. Callinan S. Reites J. Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion.NPJ Digit Med. 2022; 5: 58Crossref PubMed Scopus (4) Google Scholar There is much work to be done, and it will not be easy; however, social justice demands that we strive for diverse representation to reflect all populations in which a treatment will be used. The Journal of the American Academy of Dermatology encourages the inclusion and reporting of underrepresented groups in clinical trials as important steps toward accomplishing this goal. None disclosed. Similar response to biologic therapy across racial and ethnic groups among patients with psoriasis enrolled in the CorEvitas Psoriasis RegistryJournal of the American Academy of DermatologyVol. 87Issue 5PreviewTo the Editor: Psoriasis impacts 7 million Americans of all ethnoracial backgrounds. Racial/ethnic differences in response to biologic therapy for psoriasis have been described in clinical trials1; yet, these findings do not reflect real-world outcomes.2 Data from clinical practice are needed to further our understanding of potential variability in the effectiveness of biologics. We used data from the CorEvitas Psoriasis Registry,3 an observational cohort of patients evaluated in dermatology clinics, to better understand the response to biologics across racial/ethnic groups. 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