Planning for the unexpected: Strategies for maintaining a robust clinical trial program

Contemp Clin Trials Commun. 2020 Aug 20:19:100645. doi: 10.1016/j.conctc.2020.100645. eCollection 2020 Sep.

Abstract

During our entire history, Puerto Rico has suffered from being in the path of Hurricanes. The implications of these events during the conduction of clinical trials present a great challenge. On September 20, 2017 Puerto Rico suffered its most devastating hurricane in decades. We identified four main challenges faced as a result of the natural disaster: infrastructure damage, shortage of basic necessities, transportation difficulties and communication failure. By assessing the needs of each participant, we were able to aid with food, water and medicine. Protocols were resumed shortly after the disaster, participants were located and transportation to the research center was arranged for participants. Development of emergency plans within research protocols, allocation of emergency budgets, including transportation and communication costs, may overcome some of the challenges created by a natural disaster.

Keywords: Clinical trials; Emergency plans; Natural disasters; Protocol maintenance.