Preclinical efficacy in investigator's brochures: Stakeholders' views on measures to improve completeness and robustness

Author:

Haslberger Martin1ORCID,Schorr Susanne Gabriele1ORCID,Strech Daniel1ORCID,Haven Tamarinde1ORCID

Affiliation:

1. QUEST Center for Responsible Research Berlin Institute of Health at Charité – Universitätsmedizin Berlin Berlin Germany

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference40 articles.

1. Office of the Secretary, United States Department of Health, Education and Welfare: Protection of Human Subjects; Notice of Report for Public Comment;HHS;Fed Regist,1979

2. WMA.World Medical Association: Declaration of Helsinki ‐ Ethical Principles for Medical Research involving Human Subjects [Internet].2018. Available from:https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

3. International Conference on Harmonisation of Technical Requirement for Registration of Pharmaceuticals for Human Use.International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): Guideline for Good Clinical Practice [Internet].2016. Available from:https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf

4. International Conference on Harmonisation of Technical Requirement for Registration of Pharmaceuticals for Human Use.Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2A [Internet].1994[cited 2022 Apr 27]. Available from:https://database.ich.org/sites/default/files/E2A_Guideline.pdf

5. Preclinical efficacy studies in investigator brochures: Do they enable risk–benefit assessment?

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