July 14 2015 Amanda Rychel

The number of clinical trials incorporating independent data monitoring committees (IDMCs) for safety and efficacy monitoring is on the rise. Currently, it is recommended that late-stage trials with a major morbidity or mortality endpoint, or studies in vulnerable patient populations with a large enrollment, use an IDMC to review the interim safety and efficacy data. By definition, an IDMC is an entity that operates independent of the study sponsor. To limit bias, it is important that the sponsor is able to manage the trial while an independent body makes decisions on the safety and therapeutic values of continuing the trial.

How can the sponsor be free to make necessary modifications to a trial in progress, without the danger that those changes are influenced by access to biasing information? A model recognized by regulatory authorities is to use an independent statistical and coordinating center as a firewall to prevent unblinding information from leaking to the sponsor.  IDMC members must be free of conflicts of interest involving the sponsor and the study. Thus, outsourcing the IDMC statistical analysis, report preparation, and IDMC coordination is one way to maintain an independent IDMC and retain the sponsor blind.

PhD-level statisticians at PROMETRIKA have expertise in preparing and presenting clear, accurate, confidential interim safety and efficacy reports. Additionally, our project management team ensures strict confidentiality and smooth meeting operations by handling scheduling of IDMC meetings, report distribution, preparation of meeting minutes, and maintenance of the IDMC project file. PROMETRIKA’s statistical and IDMC coordination teams work with the sponsor to establish robust statistical analysis plans and roles and responsibilities that are in line with FDA and ICH guidance. Sponsors looking to optimize safety and efficacy monitoring and efficient study conduct are best to consider engaging independent statistical and coordination services.

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