دورية أكاديمية
Clinical trial diversity: An opportunity for improved insight into the determinants of variability in drug response.
| العنوان: | Clinical trial diversity: An opportunity for improved insight into the determinants of variability in drug response. |
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| المؤلفون: | Gross AS; Clinical Pharmacology Modelling & Simulation, GlaxoSmithKline R&D, Sydney, NSW, Australia.; Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia., Harry AC; Global Demographics & Diversity, Global Clinical Sciences and Delivery, GlaxoSmithKline R&D, Upper Providence, PA, USA., Clifton CS; Clinical Pharmacology Modelling & Simulation, GlaxoSmithKline R&D, Sydney, NSW, Australia., Della Pasqua O; Clinical Pharmacology Modelling & Simulation, GlaxoSmithKline R&D, Brentford, UK.; Clinical Pharmacology & Therapeutics Group, School of Pharmacy - University College London, London, UK. |
| المصدر: | British journal of clinical pharmacology [Br J Clin Pharmacol] 2022 Jun; Vol. 88 (6), pp. 2700-2717. Date of Electronic Publication: 2022 Feb 17. |
| نوع المنشور: | Journal Article; Review |
| اللغة: | English |
| بيانات الدورية: | Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 7503323 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2125 (Electronic) Linking ISSN: 03065251 NLM ISO Abbreviation: Br J Clin Pharmacol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Oxford : Wiley-Blackwell Original Publication: London, Macmillan Journals Ltd. |
| مواضيع طبية MeSH: | Pharmacology, Clinical*, Humans |
| مستخلص: | 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. (© 2022 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.) |
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| فهرسة مساهمة: | Keywords: age; diversity; ethnicity; recruitment; sex |
| تواريخ الأحداث: | Date Created: 20220128 Date Completed: 20220517 Latest Revision: 20220731 |
| رمز التحديث: | 20221213 |
| مُعرف محوري في PubMed: | PMC9306578 |
| DOI: | 10.1111/bcp.15242 |
| PMID: | 35088432 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1365-2125 |
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| DOI: | 10.1111/bcp.15242 |