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

Kirsten L Johansen; Anjali Acharya; Borut Cizman; Alexander R Cobitz; Ricardo Correa-Rotter; Indranil Dasgupta; Vijay Kher; Renato D Lopes; Leonardo Matsumoto; Amy M Meadowcroft; Osvaldo Merege Vieira Neto; Marilu Okabe; Brian Rayner; Arnold Silva; Hilary Thomas; Ajay K Singh

doi:10.34067/KID.0006212021

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

Kidney360. 2022 Feb 10;3(4):728-733. doi: 10.34067/KID.0006212021. eCollection 2022 Apr 28.

Authors

Kirsten L Johansen¹, Anjali Acharya², Borut Cizman³, Alexander R Cobitz³, Ricardo Correa-Rotter⁴, Indranil Dasgupta^{5

6}, Vijay Kher⁷, Renato D Lopes⁸, Leonardo Matsumoto⁹, Amy M Meadowcroft³, Osvaldo Merege Vieira Neto¹⁰, Marilu Okabe⁹, Brian Rayner¹¹, Arnold Silva¹², Hilary Thomas⁹, Ajay K Singh¹³

Affiliations

¹ Hennepin Healthcare, University of Minnesota, Minneapolis, Minnesota.
² Jacobi Medical Center, Albert Einstein College of Medicine, Bronx, New York.
³ GlaxoSmithKline, Collegeville, Pennsylvania.
⁴ Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico.
⁵ Heartlands Hospital, Birmingham, UK.
⁶ University of Warwick, Coventry, UK.
⁷ Medanta Kidney and Urology Institute, Medanta-the Medicity, Gurgaon, India.
⁸ Duke Clinical Research Institute, Duke Health, Durham, North Carolina.
⁹ PPD Worldwide Headquarters, Wilmington, North Carolina.
¹⁰ Serviço de Nefrologia de Ribeirao Preto, Sao Paulo, Brazil.
¹¹ Groote Schuur Hospital, Cape Town, Africa.
¹² Boise Kidney and Hypertension Institute, Meridian, Idaho.
¹³ Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

Abstract

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.

Keywords: COVID-19; SARS-CoV-2; chronic kidney disease; clinical trial; dialysis; pandemics.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

COVID-19* / epidemiology
Clinical Trials as Topic*
Data Collection
Humans
Pandemics*