A SPRINT to the Finish.
N Engl J Med. 2015 Nov 9;
Authors: Drazen JM, Morrissey S, Campion EW, Jarcho JA
Abstract
When investigators enroll patients in a clinical study, they make an implicit contract with each participant. Through the data and safety monitoring board (DSMB) mechanism, they fulfill the first part of the contract - protecting the participant from avoidable harm that might result from participation in the trial. They fulfill the second part of the contract - the commitment to honor the time at risk that the participant spent in the trial - by deriving the clearest and most clinically directive information possible from the data gathered during the trial. This task takes tremendous time and energy. The SPRINT (Systolic . . .
PMID: 26551058 [PubMed - as supplied by publisher]