Implications for Design and Analyses of Oncology Clinical Trials During the COVID-19 Pandemic

Author:

Moskowitz Chaya S.1,Panageas Katherine S.1

Affiliation:

1. Memorial Sloan Kettering Cancer Center, Department of Epidemiology and Biostatistics, New York, New York

Publisher

American Medical Association (AMA)

Subject

Oncology,Cancer Research

Reference5 articles.

1. Preserving clinical trial integrity during the coronavirus pandemic;McDermott;JAMA

2. Survival Analysis

3. FDA guidance on conduct of clinical trials of medical products during COVID-19 pandemic: guidance for industry, investigators, and institutional review boards. US Food and Drug Administration. Published May 2020. Accessed May 12, 2020. https://www.fda.gov/media/136238/download.

4. Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials. European Medicines Agency, Biostatistics Working Group. Published March 25, 2020. Accessed April 21, 2020. https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-implications-coronavirus-disease-covid-19-methodological-aspects-ongoing-clinical_en.pdf.

5. Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics Guidance for Industry. US Food and Drug Administration. Published December 2018. Accessed March 26, 2020. https://www.fda.gov/media/71195/download.

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