Commentaries

Inclusion of Under-represented Racial and Ethnic Minorities in Randomized Clinical Trials for Inflammatory Bowel Disease

Diverse representation in clinical trials is an important goal in the testing of a medical, diagnostic, or therapeutic intervention. To date, the desired level of trial equity and inclusivity has been unevenly achieved.

Employing the US National Library of Medicine's Clinicaltrials.gov registry, we examined 481 clinical trials conducted - at least in part - in the state of New Jersey. These trials were initiated after the FDA-mandated Common Rule changes, i.e., between January 2017 and October 2022, were enacted, and had their results posted. We analyzed sex/race/ethnicity reporting as well as applicable enrollment. Using meta-analysis, we estimated group participation proportions of a subset of the 481 identified trials; specifically, the 229 studies that were conducted solely within the US (i.e., without international sites) and compared them to US census data.

Within the 481 clinical trials analyzed, over 97% reported on the race and/or ethnicity of their enrollees; all included information on sex. Reporting was not affected by funding source or therapeutic area. Based on the 229 solely US-based studies, the participants overall were 76.7% White; 14.1% Black; 2.7% Asian; and 15% Hispanic. Inclusion of Black participants did not differ from the 2020 US census data; in contrast, the levels of Asian and Hispanic participation were below the corresponding census percentages.

The past five years have seen an overall uptick in the equity of race/ethnicity reporting and inclusivity of clinical trials, as compared to previously reported data, presaging the potential acquisition of ever more powerful and meaningful results of such interventional studies going forward.

Support for this study comes from the Hackensack Meridian Health Research Institute and the Hackensack Meridian School of Medicine.

Evidence before this study

Clinical trials are a critical part of determining whether or not a medical (drug/device/biologic) or socio-behavioral intervention is safe and truly effective. Through their use, scientific understanding is advanced and, ideally, human health is improved. To gain the most impactful information from a clinical trial, it should be sufficiently representative, that is, should enroll an adequate number of participants, and include a diverse population. Without such inclusion, the study is of only limited generalizability. Efforts are underway by funders, sites, and other stakeholders, to enhance reporting and promote inclusive enrollment. The extent to which such attempts are yielding results - at least for clinical trials in the state of New Jersey - is the focus of this data-driven analysis. The ClinicalTrials.gov registry database was carefully mined for the information contained in this report.

Added value of this study

Our analysis of clinical trials initiated in the state of New Jersey and conducted there or elsewhere in the US reveals several positive trends. Our 5-year snapshot reveals that a very large percentage of trials report on race/ethnicity - and inclusivity is improving. While there is still some way to go to have the demographic numbers in these trials match US census values, our results suggest that recent efforts are having an effect.

Implications of all the available evidence

For myriad reasons, clinical trials have not enjoyed the public's universal trust over the years. In many ways, medicine moves at the speed of trust - without it, the promise of modern healthcare is brought into question. Clinical trials must include a commitment to diverse enrollment pools and equitable reporting under the law. Creating a legacy of trust - through greater inclusivity in clinical trials and more transparent reporting of results - will begin to heal the divide and engender faith in modern medicine and today's healthcare system. It would also allow for the desired far-reaching generalizability of results across patient populations. To better appreciate what needs to be done going forward, we must truly understand the state of clinical trials reporting and demographic inclusion. This report initiates such an analysis, by carefully documenting how New Jersey's clinical trials are performing. By virtue of its location (e.g., proximity to the cities of New York and Philadelphia) the state is part of a large biopharma cluster and healthcare nexus; it is critical that it performs well with respect to adopting/adhering to updated clinical trial guideline mandates. This report provides a glimpse - an important first look - into the state of clinical trials in New Jersey - from 2017 through 2022.

Low back pain (LBP) significantly affects global health, with associated detrimental outcomes such as physical impairment, emotional distress, and exacerbated mental health symptoms. This study evaluated the representation of marginalized groups, including racialized, gender minority, pregnant/lactating, and elderly individuals in randomized controlled trials for pharmacological interventions treating LBP from 2011 to 2020. We searched Embase, MEDLINE, and CINAHL in December 2021, and 139 studies were eligible. Most trials (n = 113, 81%) reported participant sex; however, no study collected data on sexual and gender minorities, and the majority (n = 99, 71%) excluded pregnant/lactating individuals. Most trials (n = 105, 76%) reported no data on participant race or ethnicity. We limited within-country analyses of race and ethnicity to US-based trials because US-based trials were more likely to report race and/or ethnicity (48%) compared to non-US-based trials (8%). Black participants were the only racialized group whose composition was comparable to US Census estimates. About half (n = 73, 53%) of all trials had an upper age limit for eligibility (range: 40–85 years old) and 24% (n = 33) excluded adults aged >65 years. Our findings confirm that trials for pharmacological LBP interventions underreport demographic data, and the trials that include this data have unrepresentative samples. There is an urgent need for more inclusive and representative patient samples to ensure generalizability and equitable benefits. Standardizing demographic data reporting and integrating community-based participatory research methods can help foster inclusive research practices. This review was registered with prospective register of systematic reviews (PROSPERO), ID 296017.

This systematic review investigates patient representation in pharmacological-based clinical trials for low back pain, LBP, the most prevalent pain condition worldwide. Improvements in reporting demographic data and recruiting diverse participant populations—across different racialized, gender and sexual minority, and age groups—will help clinical research generalizability and provide equitable benefits.

Inflammatory bowel disease (IBD) is now recognised as a global disease, with incidence rapidly increasing in newly industrialised countries in South America, Asia, and Africa. Trials in IBD, therefore, should adequately represent diverse groups with respect to gender, age, place of residence, race, and ethnicity to ensure the global applicability and generalisability of their findings. In this systematic review, we searched PubMed and Embase for randomised controlled trials (RCTs) published in English from Jan 1, 1995, to Jan 13, 2023, evaluating the efficacy of any pharmacological intervention in patients with IBD. Of 7543 records yielded in the search, we included 617 records reporting data from 627 RCTs and 108 986 participants. The results show a paucity of adequate representation of diverse groups in these RCTs. This finding was true for various groups, including racially and ethnically diverse populations, older (aged >65 years) and younger (aged <18 years) populations, those who identify outside of the gender binary, and people from South America and Africa. Also, some regions had an apparent scarcity of funding sources for trials. Pharmaceutical companies and clinical trial organisations should aim to ensure adequate representation of such under-represented groups in future IBD trials.

The cost of caring for patients with inflammatory bowel disease (IBD) continues to increase worldwide. The cause is not only a steady increase in the prevalence of Crohn's disease and ulcerative colitis in both developed and newly industrialised countries, but also the chronic nature of the diseases, the need for long-term, often expensive treatments, the use of more intensive disease monitoring strategies, and the effect of the diseases on economic productivity. This Commission draws together a wide range of expertise to discuss the current costs of IBD care, the drivers of increasing costs, and how to deliver affordable care for IBD in the future. The key conclusions are that (1) increases in health-care costs must be evaluated against improved disease management and reductions in indirect costs, and (2) that overarching systems for data interoperability, registries, and big data approaches must be established for continuous assessment of effectiveness, costs, and the cost-effectiveness of care. International collaborations should be sought out to evaluate novel models of care (eg, value-based health care, including integrated health care, and participatory health-care models), as well as to improve the education and training of clinicians, patients, and policy makers.