Challenges of Conducting Clinical Trials during the SARS-CoV-2 Pandemic: The ASCEND Global Program Experience.

The coronavirus disease 2019 pandemic has had an unprecedented effect on health and health care and posed challenges to the conduct of clinical trials.Targeted mitigating strategies, on the basis of early and continued data collection from site surveys, limited disruption to the ASCEND trials.Flexibly allowing hemoglobin assessment at local laboratories to inform randomized treatment dosing was key to limiting the discontinuation of treatment.

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Copyright © 2022 by the American Society of Nephrology.

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A. Acharya reports consultancy fees from GlaxoSmithKline. B. Cizman, A.R. Cobitz, and A.M. Meadowcroft are employees of and stockholders in GlaxoSmithKline. R. Correa-Rotter reports scientific consulting and financial support for participation in clinical trials: AstraZeneca DAPA-CKD trial steering committee, GlaxoSmithKline for ASCEND Investigator and National Leader, Novonordisk FLOW national leader and investigator; is an advisory board member for Amgen, AbbVie, Boehringer Ingelheim, and Medtronic; and is a speaker for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Janssen, and Sanofi. I. Dasgupta reports research grants from Medtronic and Sanofi-Genzyme and is an advisory board member for AstraZeneca and GlaxoSmithKline. K.L. Johansen reports consultancy fees from GlaxoSmithKline and Akebia. V. Kher reports local INDA consultancy agreements with AstraZeneca, Biocon Pharmaceuticals, GlaxoSmithKline, Intas Pharmaceuticals, Novartis, Panacea, Roche, RPG Life Sciences, Sanofi Aventis, and Torrent Pharmaceuticals; research funding from Astellas India, Novartis India, and Sanofi Aventis India; honoraria from Astellas India, Intas India, JB Pharmaceuticals India, Novartis India, Reddy’s India, Roche India, and Torrent India; is a scientific advisor for Biocon India, Medtronics, Novartis India, Reddy’s India, Roche India, Sanofi Aventis, Torrent, and Wockhardt India; participates in a speakers’ bureau for AstraZeneca India, Biocon India, Intas India, JB Pharmaceuticals, Johnson and Johnson, Novartis India, Panacea India, Pfizer, Roche India, and Sanofi Aventis India. R.D. Lopes reports grants and personal fees from Bristol-Myers Squibb and Pfizer, personal fees from Bayer AG and Boehringer Ingelheim, and research grants from Amgen, Inc., GlaxoSmithKline, Medtronic plc, and Sanofi Aventis. B. Rayner reports honoraria for CME talks from AstraZeneca, Boehringer Ingelheim, Merck, Novartis, Sandoz, and Servier, and has served on a Servier Advisory Board. A.L. Silver reports research funding from Akebia, Ardelyx, Boehringer Ingelheim, Bayer AG, DiaMedica, Fibrogen/AstraZeneca, GlaxoSmithKline, Goldfinch Bio, Novartis, ProKidney, Reata, and Retrophin; consultancy fees from Ardelyx, Boehringer Ingelheim, Novartis, ProKidney, and Reata; and participates in a speakers’ bureau for Amgen, AstraZeneca, and Aurinia. A.K. Singh reports consultancy fees from GlaxoSmithKline. All remaining authors have nothing to disclose.