Decentralization of clinical trials in the era of COVID-19: Implications for rare disease trials

In March 2020, New York City became the epicenter of the COVID-19 pandemic, and “The New York State on PAUSE” executive order effectively closed all non-essential businesses statewide. In order to mitigate the public health burden, most ongoing clinical trials visits were suspended, or needed to rapidly shift to home visits only. Nationwide, between December 1, 2019 and July 1, 2020, 1473 clinical trials were suspended, terminated, or withdrawn with a reported reason that explicitly mentioned COVID-19.