The impact of the global COVID‐19 pandemic on the conduct of clinical trials: Return to normalcy by considering the practical impact of a structured ethical analysis

Author:

Vissers Maurits F.J.M.1ORCID,Cohen Adam F.12,Van Gerven Joop M.A.23ORCID,Groeneveld Geert Jan12

Affiliation:

1. Centre for Human Drug Research Zernikedreef 8 Leiden CL 2333 The Netherlands

2. Leiden University Medical Center Albinusdreef 2 Leiden ZA 2333 The Netherlands

3. Central Committee on Research Involving Human Subjects Parnassusplein 5 The Hague VX 2511 The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference65 articles.

1. World Health Organization.Speeches. WHO Director‐General's opening remarks at the media briefing on COVID‐19. 11 Mar. Published 2020.https://www.who.int/dg/speeches/detail/who‐director‐general‐s‐opening‐remarks‐at‐the‐media‐briefing‐on‐covid‐19‐‐‐11‐march‐2020

2. Coronavirus shuts down trials of drugs for multiple other diseases

3. COVID‐19 will spur decentralized and hybrid trials – Novartis hails digital investment;McConaghie A;Scrip ‐ Inf Pharmac Intell,2020

4. US National Library of Medine.ClinicalTrials.gov. Interventional Studies COVID‐19. 20 Apr. Published 2020. Accessed April 20 2020.https://clinicaltrials.gov/

5. European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA).Guidance on the Management of Clinical Trials during the COVID ‐ 19 (Coronavirus) pandemic. Published online 2020.

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