Open Access BASE2017

Data monitoring committees: Promoting best practices to address emerging challenges

Fleming, Thomas R; DeMets, David L; Roe, Matthew T; Wittes, Janet; Calis, Karim A; Vora, Amit N; Meisel, Alan; Bain, Raymond P; Konstam, Marvin A; Pencina, Michael J; Gordon, David J; Mahaffey, Kenneth W; Hennekens, Charles H; Neaton, James D; Pearson, Gail D; Andersson, Tomas LG; Pfeffer, Marc A; Ellenberg, Susan S

Order using Access(Open Access)

Abstract

Data Monitoring Committees (DMCs) are responsible for safeguarding the interests of study participants and assuring the integrity and credibility of clinical trials. The independence of DMCs from sponsors and investigators is essential to achieving this mission. Creative approaches are needed to address ongoing and emerging challenges that potentially threaten DMCs' independence and effectiveness. An expert panel of representatives from academia, industry and government sponsors, and regulatory agencies discussed these challenges and proposed best practices and operating principles for effective functioning of contemporary DMCs.

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