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• W3200362012 abstract "The inflammatory bowel diseases (IBD), consisting of Crohn’s disease and ulcerative colitis, have historically been described predominantly in Western countries and in White populations, but there has been a steady increase in both incidence and prevalence across the globe and in varying racial and ethnic groups.1Alatab S. Sepanlou S.G. Ikuta K. et al.The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017.Lancet Gastroenterol Hepatol. 2020; 5: 17-30Abstract Full Text Full Text PDF PubMed Scopus (446) Google Scholar A study describing trends in incidence rates of IBD by race in the United States highlighted an increase in incidence of IBD of 134% in non-White populations between 1970 and 2010.2Aniwan S. Harmsen W.S. Tremaine W.J. Loftus Jr., E.V. Incidence of inflammatory bowel disease by race and ethnicity in a population-based inception cohort from 1970 through 2010.Therap Adv Gastroenterol. 2019; 12 (1756284819827692)Crossref PubMed Scopus (22) Google Scholar Furthermore, the incidence of IBD in non-White populations was 60% that of White populations between 2000 and 2010, an increase of 16% compared with the previous decade and a half.2Aniwan S. Harmsen W.S. Tremaine W.J. Loftus Jr., E.V. Incidence of inflammatory bowel disease by race and ethnicity in a population-based inception cohort from 1970 through 2010.Therap Adv Gastroenterol. 2019; 12 (1756284819827692)Crossref PubMed Scopus (22) Google Scholar IBD therapies have received regulatory approval based on preclinical and clinical studies in humans, and in the United States the approval and subsequent labeling comes from the US Food and Drug Administration (FDA). Of note is that although non-Hispanic, White Americans represent 60.1% of the US population and Black/African American and Hispanic people comprise approximately 30% of the population,3US CensusTable results. Available at:.https://data.census.gov/cedsci/table?d=ACS 5-Year Estimates Data Profiles&table=DP05&tid=ACSDP5Y2018.DP05&g=0400000US06Google Scholar non-Hispanic White people of European descent comprise over 90% of clinical trial participants across all fields of medicine.4US Census BureauCensus Bureau, United States. Oficina del Censo de EE.UU. Published 2000. Available at:.https://www.census.gov/quickfacts/fact/table/US/PST045219%0Ahttp://www.census.gov/population/international/data/idb/region.php?N= Results &T=4&A=separate&RT=0&Y=2014&R=–1&C=MXGoogle Scholar,5Ma M.A. Gutiérrez D.E. Frausto J.M. Al-Delaimy W.K. Minority representation in clinical trials in the United States: trends over the past 25 years.Mayo Clin Proc. 2021; 96: 264-266Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar As such, there are multiple limitations in applying the data generated from these clinical trials across all patients treated in clinical practice, including those with IBD. This imbalance may affect the ability to ascertain differences regarding drug efficacy, safety, and toxicity because potential differences in genetic makeup and thus pharmacokinetics are not taken into account, as has been shown regarding various medications used to treat cancer.6Collins F.S. Varmus H. A new initiative on precision medicine.N Engl J Med. 2015; 372: 793-795Crossref PubMed Scopus (2974) Google Scholar It is important to understand the meaning of the terms “race” and “ethnicity”; race is generally defined as physical traits common to a group of people with shared ancestry, whereas ethnicity is defined as the cultural identification of a person or group of people. Racial or ethnic inequality in clinical trials has consequences beyond the clinical efficacy of a particular medication. First, it highlights the inequality minorities face accessing high-quality health care, particularly in the United States.7Sealy-Jefferson S. Vickers J. Elam A. Wilson M.R. Racial and ethnic health disparities and the Affordable Care Act: a status update.J Racial Ethn Health Dispar. 2015; 2: 583-588Crossref PubMed Scopus (31) Google Scholar Second, it potentially hampers the provider’s ability to garner the trust of patients when offering various treatments and likewise may affect the acceptability of treatments from the patient perspective.8Corbie-Smith G. Thomas S.B. George DMM S.t. Distrust, race, and research.Arch Intern Med. 2002; 162: 2458-2463Crossref PubMed Scopus (715) Google Scholar Here we describe the racial and ethnic representation in IBD clinical trials, whether these changed over time, and provide suggestions for future improvements in clinical trial design, recruitment, execution, and interpretation. We systematically reviewed phase II, phase III, and open-label long-term extension trials investigating the efficacy and safety of FDA-approved therapies in IBD (details in Table 1). Each publication, supplementary material, table, and abstract was examined for race and ethnicity data. The proportion of trials reporting race or ethnicity and those reporting more than 1 racial group were calculated among all reported. The proportion of patients of a particular race or ethnicity was reported after exclusion of trials that did not report on race or ethnicity. Group comparisons was performed using the χ2 or Fisher exact test, the Student t test for parametric data, or a Mann-Whitney U test for nonparametric data, as appropriate. P values were considered statistically significant when <.05. Analysis was performed using IBM SPSS (version 26, Armonk NY).Table 1Details of Race and Ethnicity Reporting in the Clinical Trials of IBD TherapeuticsCategoryDrug (n = trials included)All studies combined (N=55)Infliximab (n = 5)Adalimumab (n = 6)Certolizumab pegol (n = 3)Golimumab (n = 3)Vedolizumab (n = 9)Natalizumab (n = 3)Ustekinumab (n = 7)Tofacitinib (n = 6)5-Aminosalicylate (n = 10)Race reported32 (58.2)4 (80)1 (16.7)1 (33)3 (100)6 (67)2 (67)6 (86)6 (100)4 (40)Ethnicity reported10 (18.2)0 (0)0 (0)0 (0)0 (0)5 (56)1 (33)1 (14)0 (0)3 (30)Increased breakdown of racial groups20 (36.4)2 (40)1 (16.7)0 (0)3 (100)5 (56)2 (67)2 (28)2 (33)3 (30)Mean no. of continents participating (±SD)2.9 (1.3)2.4 (0.9)2.2 (0.4)3.7 (0.6)4 (0)2.8 (1.4)2.3 (1.2)3.7 (0.95)4.5 (0.5)1.8 (1.3)Mean no. of countries participating (±SD)14.4 (10.8)9.6 (3.6)10.5 (4.3)19 (2.6)25.3 (0.5)17.9 (17.5)9.3 (7.6)20.1 (9.2)22.5 (5.8)4.8 (5.4)Race White, mean (±SD)85.8 (9.1)93.6 (5.9)889581.7 (1.6)90.3 (5.8)93 (2.8)81.7 (5.9)80.3 (2)81.8 (15) Black, mean (±SD)2.9 (3.3)5 (7)6NR1.3 (1.2)1.4 (0.9)3.5 (2.1)0.8 (0.4)3.5 (0.7)4.8 (4.2) Asian, mean (±SD)7.1 (7)0.7 (0.6)1.5NR13.7 (2.1)5.4 (3.4)0.3 (0.2)15.3 (0.4)13.5 (2.1)11.1 (10.3) Hawaiian/Pacific Islander, mean (±SD)0.03 (0.05)0NRNRNR0.1 (0.1)NRNRNR0 Native American/Alaskan, mean (±SD)1.2 (1.6)NRNRNRNR0.1 (0.6)NR0.1NR3.5 Hispanic - mean (±SD)5.2 (4.5)NRNRNRNR3 (0)0.32.5NR7.8 (1.83)Other, mean (±SD)3.2 (2.7)3 (2.9)4.552.7 (1.5)3.2 (3.8)2.5 (1.1)12.3 (5.9)13.5 (9.4)3.6 (2.14)Values are n (%) unless otherwise defined. NR, not reported; SD, standard deviation. Open table in a new tab Values are n (%) unless otherwise defined. NR, not reported; SD, standard deviation. The search yielded 641 publications. Of these, 55 publications of 9 distinct therapies with 24,315 participants met the inclusion criteria and were included in this analysis. The year of publication ranged from 1960 to 2020. Forty-four (80%) phase III trials and 11 (20%) phase II trials were included. The number of studies investigating each of the included medications was as follows: 11 5-aminosalicylate, 18 anti–tumor necrosis factor (6 infliximab and 6 adalimumab, 3 certolizumab pegol, 3 golimumab), 4 natalizumab, 9 vedolizumab, 7 ustekinumab, and 6 tofacitinib. Thirty-two trials (58.2%) included race demographics and 10 (19.6%) included ethnicity demographics. Of these 32 clinical studies, 12 (37.5%) clinical trials only mentioned the percentage of White participants and 20 (62.5%) reported increased breakdown of race demographics including a combination of White, Black, Asian, native Hawaiian or Pacific Islander, Native American, Hispanic and Other. Details of the trials can be found in Table 1. Of the 10 studies reporting on ethnicity, all were binary (ie, Hispanic and not Hispanic and in all studies over 95% of the study population were not Hispanic). There was no mention of race or limitations surrounding racial or ethnicity inclusion in the discussion section of any of the included publications. Among all studies detailing race or ethnicity, the proportion of White participants was 86.1% ± 8.4%. Because the number of trials reporting on the proportions of native Hawaiian or Pacific Islander, Native American, and Hispanic racial groups was low, we looked at studies describing the proportions of at least White, Black, and Asian racial groups (n = 21). Among these studies, the proportions of Whites, Blacks, Asians, or others were 85.8% ± 9.1%, 2.9% ± 3.3%, 7.1% ± 7%, and 3.2% ± 2.7%, respectively. Based on reports that the racial, ethnic, and geographic incidence and prevalence of IBD is changing in recent years, we then divided the studies into those conducted and completed before the year 2000, those between 2000 and 2010 and those conducted and completed after 2010 to assess for any time trend changes in study enrollment. There was a statistically significant increase in both participating continents and clinical trials in the decade 2010–2020 compared with the prior decade (continents, 3.8 ± 0.6 vs 2.3 ± 1.2 [P = .006]; countries, 25.1 ± 9.4 vs 8.1 ± 5 [P <.001], respectively). No studies reported race or ethnicity demographics before the year 2000. Of the 25 studies conducted between 2000 and 2010, 10 (40%) reported race or ethnicity demographics, and from the year 2010 there was a statistically significant increase in the number of studies reporting race or ethnicity compared with the previous decades with 20 studies (80%) reporting race demographics (34% vs 80%, P = .001). Among studies detailing White, Black, and Asian participants, there was a significant increase in the proportion of Asian participants (10.5% ± 5.1% vs 2.7% ± 6.8%, respectively; P = .009). In this analysis and commentary, we identify that the reporting of race and ethnicity and the inclusion of diverse and under-represented populations the clinical trials of therapies for IBD have been poor. Almost 40% of the studies had no report of race at all, and a further 23% reported only the proportion of White participants without mention of other races. Furthermore, the participation of Black/African American and Hispanic populations was very low across all the clinical trials in contrast with the increased incidence of IBD in these populations during a similar period. All trials of investigational agents included in this analysis led to approval and subsequent use across the diverse US population at large and, usually later, in many other countries of the world. As such, the lack of racial or ethnic representation in these trials is disappointing and concerning. In the United States many groups of people and particularly under-represented minorities are disproportionately burdened by negative health indicators including chronic illnesses and shortened life expectancy, in particular in diseases such as asthma, diabetes, obesity, mental illness, and cardiovascular disease.7Sealy-Jefferson S. Vickers J. Elam A. Wilson M.R. Racial and ethnic health disparities and the Affordable Care Act: a status update.J Racial Ethn Health Dispar. 2015; 2: 583-588Crossref PubMed Scopus (31) Google Scholar,9Price J.H. Khubchandani J. McKinney M. Braun R. Racial/ethnic disparities in chronic diseases of youths and access to health care in the United States.Biomed Res Int. 2013; 2013: 787616Crossref PubMed Scopus (77) Google Scholar Under-represented minorities also have disproportionately poor access to medical insurance and as an extension adequate healthcare resources.10Sohn H. Racial and ethnic disparities in health insurance coverage: dynamics of gaining and losing coverage over the life-course.Popul Res Policy Rev. 2017; 36: 181-201Crossref PubMed Scopus (119) Google Scholar These health disparities have been previously defined as health differences that are closely related to systemic and structural racism,11American Public Health AssociationStructural racism is a public health crisis: impact on the black community. Policy Number: LB20-04. Published 2020. Available at:.https://www.apha.org/policies-and-advocacy/public-health-policy-statements/policy-database/2021/01/13/structural-racism-is-a-public-health-crisisGoogle Scholar implicit biases of healthcare providers, and social, economic, and environmental disadvantages.12Blair I.V. Steiner J.F. Havranek E.P. Unconscious (implicit) bias and health disparities: where do we go from here?.Perm J. 2011; 15: 71-78Crossref PubMed Google Scholar As such, a multifaceted approached to diminishing factors associated with these disparities is required. The field of clinical trials in medicine, both those funded by private industry and those funded by the National Institutes of Health, has been wrought with racial disparities.13Loree J.M. Anand S. Dasari A. et al.Disparity of race reporting and representation in clinical trials leading to cancer drug approvals from 2008 to 2018.JAMA Oncol. 2019; 5: e191870Crossref PubMed Scopus (132) Google Scholar,14Berger J.S. Melloni C. Wang T.Y. et al.Reporting and representation of race/ethnicity in published randomized trials.Am Heart J. 2009; 158: 742-747Crossref PubMed Scopus (36) Google Scholar The reasons for such disparities are multiple and include physician and investigator biases and perceptions, patients factors, and structural factors relating to access to medical care, expertise, or clinical trials. Physician and investigator biases include the likelihood of harboring negative impressions (such as lower degree of education or intellect) of Black/African American patients compared with White patients as well as preconceived ideas regarding which of their patients are more likely to comply with medical regimens, which may lead to the under-recruitment of minorities into trials.15Van Ryn M. Burke J. The effect of patient race and socio-economic status on physicians’ perceptions of patients.Soc Sci Med. 2000; 50: 813-828Crossref PubMed Scopus (979) Google Scholar Patients factors include the harboring of certain degrees of suspicion of clinical trials because of prior exploitation, particularly in the Black/African American population, who are more likely to feel experimented on.8Corbie-Smith G. Thomas S.B. George DMM S.t. Distrust, race, and research.Arch Intern Med. 2002; 162: 2458-2463Crossref PubMed Scopus (715) Google Scholar,16Corbie-Smith G. Thomas S.B. Williams M.V. Moody-Ayers S. Attitudes and beliefs of African Americans toward participation in medical research.J Gen Intern Med. 1999; 14: 537-546Crossref PubMed Scopus (768) Google Scholar Finally, structural issues including the economic, educational, and social ramifications of structural racism such as requiring multiple jobs to earn a living, transportation difficulties in getting to appointments, language barriers hampering a clear understanding of IBD, poorer access to medical care than their White counterparts, and limited access to medical care due to resource-poor hospitals and clinics where clinical trials may not be available.17Hasnain-Wynia R. Baker D.W. Nerenz D. et al.Disparities in health care are driven by where minority patients seek care: examination of the hospital quality alliance measures.Arch Intern Med. 2007; 167: 1233-1239Crossref PubMed Scopus (244) Google Scholar In this analysis, we demonstrate that despite an increasing number of participating clinical sites, countries, and continents included in clinical trials of therapies for IBD, the proportion of Black/African American and Hispanic participants remained very low. This may be due to an increase in the number of White- and Asian-predominant countries participating in the trials, because the proportion of Asian participants significantly increased over the same period. Although this occurrence may reflect a greater generalizability of clinical trial results on a global scale, it does not translate well to issues in the United States, which has the largest number of patients with IBD of any single nation in the world and in which most therapies have been developed and subsequently prescribed. There are many reasons why medicine as a whole and clinical trial recruitments in particular need to strive for greater equality and access among minoritized groups. First, patients with different genetic makeups may have differences in inflammatory pathways driving disease, drug pharmacokinetics, and drug metabolism that affect effectiveness and safety in different populations. Second, the physician–patient relationship is a vital cornerstone of medical practice. The establishment of this bond allows for the successful implementations of therapeutic strategies and increases the chances of success and compliance.18Goold S.D. Lipkin M. The doctor-patient relationship: challenges, opportunities, and strategies.J Gen Intern Med. 1999; 14: S26Crossref PubMed Scopus (171) Google Scholar A lack of representation in clinical trials can make it difficult for the physician to engage minoritized patients in treatments that have not been tested on patients of similar backgrounds. Greater representation in clinical trials (and of providers) will increase trust between providers and minoritized patients, and positive trial experiences may translate to greater trust in the medical system as a whole. Third, and no less important, all people regardless of race, ethnicity, religion, gender identity, or socioeconomic circumstance should have equal access to all levels of health care. The FDA has attempted to improve racial disparity by developing an action plan to prioritize the reporting, participation, and transparency of minorities in clinical trials. This is due in part to the realization on the FDA’s behalf that inadequate representation or data analyses from clinically relevant subpopulations can lead to insufficient data regarding the effectiveness and safety of medications across all patient populations.19US Food and Drug AdministrationFDA Administration Safety and Innovation Act (FDASIA), Section 907 action plan. Published 2012. Available at:.https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/%0AFDASIA/ucm389100.htmGoogle Scholar Although it is unclear exactly how to implement these recommendations and what penalties will be incurred for lack of compliance, this is a step in the right direction and may be responsible, in part, for the increased reporting in this last decade. In Table 2 we propose action items we believe are needed to truly correct these inequities. Separately, we would encourage investment into understanding the barriers and cultural and socioeconomic challenges to the delivery of high quality and available care to all.Table 2Priorities for Improved Engagement and Recruitment of Under-represented Individuals in Clinical Trials for Therapies in Patients With IBDPhase of studyProposed action itemDesignDesign studies with adequate power to examine efficacy and safety in under-represented groupsRecruitmentDevelop recruitment strategies aimed to enroll under-represented groups and to address trial hesitancyReportingConsistent and standardized requirements for reporting of race and ethnicity data across clinical trials and description of methods used to ascertain race/ethnicityAnalysisA priori subset interpretation of clinical trial data should include minoritized groupsPostregulatory approvalDirected and dedicated communication and follow-up of therapies in under-represented groups in post marketing (phase IV) studiesOutside of clinical trialsStudies investigating and reporting disparities of care in IBD and racial inequalities in health outcomes Open table in a new tab There are limitations to the interpretation of these data. Most of these studies were conducted on a global scale and thus alter the relative proportions of the races accordingly, as noted above with greater participation of Asian countries. Furthermore, clinical trials do not provide subgroup data detailing racial demographics per country, which in turn limits our ability to understand recruitment practices in countries with more racially diverse populations, such as the United States. Having said this, the FDA approves therapies for the US population based on these worldwide clinical trials, so it is indeed fair to criticize the racial and ethnicity disparities noted. Another limitation is that the prevalence of IBD in minority populations, although on the rise, is still significantly lower than the prevalence in the White population, and thus the racial disparity, although present, is not as large as that noted in other fields of medicine.20Mak W.W.S. Law R.W. Alvidrez J. Pérez-Stable E.J. Gender and ethnic diversity in NIMH-funded clinical trials: review of a decade of published research.Adm Policy Ment Health Serv Res. 2007; 34: 497-503Crossref PubMed Scopus (69) Google Scholar Additionally, potential implicit bias is difficult to assess because retrospectively it was difficult to accurately determine the race and ethnicity of the contributing investigators and authors. Furthermore, protocols of most studies are unclear as to exactly how race or ethnicity was determined, whether provided by the patient questionnaires or determined by the primary investigator or researcher, which limits interpretation. We have described a significant racial disparity and a very low proportion of racial minorities in phase II and III clinical trials of therapies for IBD and limited reporting of ethnicity data. These disparities are likely due to multiple factors, and we propose that greater effort be made at multiple levels for the appropriate participation of all racial and ethnic groups in clinical trials and that there should be multiple stakeholder investments to address these challenges in the phases of development of therapies. We believe these initiatives will enhance equitability of clinical trials in IBD, build trust between providers and patients of diverse backgrounds, further our understanding of disease processes and response to treatment in different patient populations, and ultimately improve the quality of life for all people living with IBD." @default.
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• W3200362012 title "Inclusion of Under-represented Racial and Ethnic Minorities in Randomized Clinical Trials for Inflammatory Bowel Disease" @default.
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