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.
DOIAbstract
The coronavirus disease 2019 (COVID-19) pandemic has had an unprecedented effect on health and health care. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has strained health care systems and caused disruption to non-COVID-19-related health care. Although the premature interruption or disruption of clinical trials is less well recognized, it has the potential to threaten the development of new non-COVID-19-related therapies (1⇓–3). Study disruptions need to be rapidly identified and addressed to preserve the integrity of ongoing studies and the design of new ones. Here, we describe the challenges that arose in three global phase 3 trials and the strategies undertaken to maintain and adapt the conduct of the studies safely d...
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