Data monitoring committees: Promoting best practices to address emerging challenges

Abstract

<p class="first" id="P1">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. </p><p id="P2">Prospective DMC members need better training. Options could include didactic instruction as well as apprenticeships to provide real-world experience. DMC members should be protected against legal liability arising from their service. While avoiding breaches in confidentiality of interim data remains a high priority, DMCs should have access to unblinded efficacy and safety data throughout the trial to enable informed judgments about risks and benefits. Because overly rigid procedures can compromise their independence, DMCs should have the flexibility necessary to best fulfill their responsibilities. DMC charters should articulate principles that guide the DMC process rather than list a rigid set of requirements. DMCs should develop their recommendations by consensus rather than through voting processes. The format for DMC meetings should maintain the independence of the DMC and clearly establish the leadership of the DMC chair. The independent statistical group at the Statistical Data Analysis Center should have sufficient depth of knowledge about the study at hand and experience with trials in general to ensure that the DMC has access to timely, reliable, and readily interpretable insights about emerging evidence in the clinical trial. Contracts engaging DMC members for industry-sponsored trials should have language customized to the unique responsibilities of DMC members rather than use language appropriate to consultants for product development. Regulatory scientists would benefit from experiencing DMC service that does not conflict with their regulatory responsibilities. </p>