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. 2021 Aug;11(8):1881-1885.
doi: 10.1158/2159-8290.CD-21-0850. Epub 2021 Jul 21.

Rethinking Cancer Clinical Trial Conduct Induced by COVID-19: An Academic Center, Industry, Government, and Regulatory Agency Perspective

Keith T Flaherty  1 , James H Doroshow  2 , Susan Galbraith  3 , Antoni Ribas  4 , Paul G Kluetz  5 , Richard Pazdur  5 , Marc R Theoret  5
Affiliations

Rethinking Cancer Clinical Trial Conduct Induced by COVID-19: An Academic Center, Industry, Government, and Regulatory Agency Perspective

Keith T Flaherty et al. Cancer Discov. 2021 Aug.

Abstract

The COVID-19 pandemic brought about major changes in cancer clinical trials. In its aftermath, the community has an opportunity to incorporate some of these changes as part of the future of trial conduct to make it more patient centered.

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Conflict of interest statement

Conflict of Interest Disclosure:

K.T.F serves on the Board of Directors of Clovis Oncology, Strata Oncology, Kinnate, Checkmate Pharmaceuticals, and Scorpion; Scientific Advisory Boards of PIC Therapeutics, Apricity, Tvardi, xCures, Monopteros, and Vibliome; consultant to Lilly, Takeda, and Boston Biomedical; and research funding from Novartis and Sanofi.

J.H.D. No conflicts to disclose.

S.G. is a full time employee of AstraZeneca; is a member of the board of directors of BB Biotech; holds stock in AstraZeneca.

A.R. has received honoraria from consulting with Amgen, Bristol-Myers Squibb, Chugai, Genentech, Merck, Novartis, Roche, Sanofi and Vedanta; is or has been a member of the scientific advisory board and holds stock in Advaxis, Apricity, Arcus, Compugen, CytomX, Five Prime, Highlight, Lutris, ImaginAb, Isoplexis, Kalthera, Kite-Gilead, Merus, PACT Pharma, RAPT, Rgenix and Tango; is a member of the board of directors of Arcus, Lutris and PACT Pharma; has received research funding from Agilent and from Bristol-Myers Squibb through Stand Up to Cancer (SU2C).

P.G.K. No conflicts to disclose

R.P. No conflicts to disclose

M.R.T. No conflicts to disclose

Figures

Figure 1.
Figure 1.. Change in the clinical trial conduct accelerated by the COVID-19 pandemic.
A) The clinical trials enterprise had evolved over decades to have the clinical trial site as the center of the action, where patients would need to go for consenting, clinical trial procedures and experimental therapies were provided, regardless if they were oral or infused. Also, monitors and auditors performed their work onsite. B) Accelerated by the need to adapt to the COVID-19 pandemic, the patient was put at the center of the clinical trials activity, allowing remote consenting without having to go to the clinical trial site, being able to do laboratory tests at home or at a local facility, having drugs delivered at home, and having monitoring and auditing remotely.
See this image and copyright information in PMC

References

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