Clinical trial diversity: An opportunity for improved insight into the determinants of variability in drug response

Author:

Gross Annette S.12ORCID,Harry Anya C.3,Clifton Christine S.1,Della Pasqua Oscar45ORCID

Affiliation:

1. Clinical Pharmacology Modelling & Simulation, GlaxoSmithKline R&D Sydney NSW Australia

2. Sydney Pharmacy School, Faculty of Medicine and Health The University of Sydney Sydney NSW Australia

3. Global Demographics & Diversity, Global Clinical Sciences and Delivery GlaxoSmithKline R&D Upper Providence PA USA

4. Clinical Pharmacology Modelling & Simulation, GlaxoSmithKline R&D Brentford UK

5. Clinical Pharmacology & Therapeutics Group School of Pharmacy – University College London London UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference105 articles.

1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.ICH Harmonised Tripartite Guideline. ICH E5 (R1): Ethnic Factors in the Acceptability of Foreign Clinical Data.1998. Accessed August 5 2020.https://database.ich.org/sites/default/files/E5_R1__Guideline.pdf

2. International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.ICH Harmonised Guidelines. General Principles for Planning and Design of Multi‐Regional Clinical Trials. ICH E17.2017. Accessed October 6 2020.https://database.ich.org/sites/default/files/E17EWG_Step4_2017_1116.pdf

3. Diversity in randomized clinical trials of depression: A 36-year review

4. Ten‐Year Trends in Enrollment of Women and Minorities in Pivotal Trials Supporting Recent US Food and Drug Administration Approval of Novel Cardiometabolic Drugs

5. Under‐representation of elderly in clinical trials: An analysis of the initial approval documents in the Food and Drug Administration database

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