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Challenges of Conducting Clinical Trials during the SARS-CoV-2 Pandemic: The ASCEND Global Program Experience.
Johansen, Kirsten L; Acharya, Anjali; Cizman, Borut; Cobitz, Alexander R; Correa-Rotter, Ricardo; Dasgupta, Indranil; Kher, Vijay; Lopes, Renato D; Matsumoto, Leonardo; Meadowcroft, Amy M; Merege Vieira Neto, Osvaldo; Okabe, Marilu; Rayner, Brian; Silva, Arnold; Thomas, Hilary; Singh, Ajay K.
  • Johansen KL; Hennepin Healthcare, University of Minnesota, Minneapolis, Minnesota.
  • Acharya A; Jacobi Medical Center, Albert Einstein College of Medicine, Bronx, New York.
  • Cizman B; GlaxoSmithKline, Collegeville, Pennsylvania.
  • Cobitz AR; GlaxoSmithKline, Collegeville, Pennsylvania.
  • Correa-Rotter R; Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico.
  • Dasgupta I; Heartlands Hospital, Birmingham, UK.
  • Kher V; University of Warwick, Coventry, UK.
  • Lopes RD; Medanta Kidney and Urology Institute, Medanta-the Medicity, Gurgaon, India.
  • Matsumoto L; Duke Clinical Research Institute, Duke Health, Durham, North Carolina.
  • Meadowcroft AM; PPD Worldwide Headquarters, Wilmington, North Carolina.
  • Merege Vieira Neto O; GlaxoSmithKline, Collegeville, Pennsylvania.
  • Okabe M; Serviço de Nefrologia de Ribeirao Preto, Sao Paulo, Brazil.
  • Rayner B; PPD Worldwide Headquarters, Wilmington, North Carolina.
  • Silva A; Groote Schuur Hospital, Cape Town, Africa.
  • Thomas H; Boise Kidney and Hypertension Institute, Meridian, Idaho.
  • Singh AK; PPD Worldwide Headquarters, Wilmington, North Carolina.
Kidney360 ; 3(4): 728-733, 2022 04 28.
Article in English | MEDLINE | ID: covidwho-1955524
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Clinical Trials as Topic / Pandemics / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Kidney360 Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Clinical Trials as Topic / Pandemics / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Kidney360 Year: 2022 Document Type: Article