| Title | Clinical trial diversity: An opportunity for improved insight into the determinants of variability in drug response |
| Publication Type | Journal Article |
| Year of Publication | 2022 |
| Authors | Gross AS, Harry AC, Clifton CS, Pasqua ODella |
| Journal | British Journal of Clinical PharmacologyBritish Journal of Clinical Pharmacology |
| Volume | 88 |
| Pagination | 2700-2717 |
| Type of Article | Article |
| ISBN Number | 03065251 |
| Accession Number | 156806392 |
| Keywords | age, CLINICAL pharmacology, clinical trials, diversity, Diversity in clinical trials, DRUG registration, ETHNICITY, government agencies, Patient Advocacy, PRESSURE groups, recruitment, SEX |
| Abstract | Although the number of countries participating in pivotal trials submitted to enable drug registration has nearly doubled over the past 25 years, there has not been a substantial increase in the diversity of clinical trial populations. In parallel, our understanding of factors that influence medicine response and variability has continued to evolve. The notion of intrinsic and extrinsic sources of variability has been embedded into different regulatory guidelines, including the recent guideline on the importance of enhancing the diversity of clinical trial populations. In addition to presenting the clinical and scientific reasons for ensuring that clinical trial populations represent the demographics of patient populations, this overview outlines the efforts of regulatory agencies, patient advocacy groups and clinical researchers to attain this goal through strategies to meet representation in recruitment targets and broaden eligibility criteria. Despite these efforts, challenges to participation in clinical trials remain, and certain groups continue to be underrepresented in development programmes. These challenges are amplified when the representativeness of specific groups may vary across countries and regions in a global clinical programme. Whilst enhanced trial diversity is a critical step towards ensuring that results will be representative of patient populations, a concerted effort is required to characterise further the factors influencing interindividual and regional differences in response for global populations. Quantitative clinical pharmacology principles should be applied to allow extrapolation of data across groups or regions as well as provide insight into the effect of patient‐specific characteristics on a medicine's dose rationale and efficacy and safety profiles. [ABSTRACT FROM AUTHOR] Copyright of British Journal of Clinical Pharmacology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
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