The National Heart, Lung, and Blood Institute (NHLBI) hosted the Data Coordinating Centers’ Best Practices Working Group on May 24-25, 2011 to identify and create a compendium of best practices for Data Coordinating Centers (DCC) that support large clinical trial programs such as Networks or multicenter clinical studies. The compendium will serve as a resource to NHLBI Program Staff for crafting application and review criteria for RFAs/RFPs and when evaluating DCCs as part of a large clinical trial program. This document focuses upon DCCs which partner with extramural investigators through grant mechanisms and with the NHLBI through contract mechanisms, and does not address Clinical Research Organizations which contract to recruit study sites.

Background

The DCC is often the nucleus for the success of a large clinical research program. The DCC brings expertise in clinical trial design and conduct needed to complement the clinical investigators’ content expertise, and structure and quality standards to the design and conduct of a trial. An effective DCC collaborates in protocol development and takes responsibility for statistical design including sample size calculations and data analysis strategy. The DCC provides common questionnaires, data collection forms and data management; statistical analysis; collaborates in manuscript preparation; and provides overall study training, coordination and quality assurance, including coordination of the activities of the Data and Safety Monitoring Board (DSMB), the Protocol Review Committee (PRC), the Steering Committee, and other standing committees. Additional activities may include selection and evaluation of clinical center awardees; support of ancillary study activities; procurement of services related to core labs, study drug acquisition and distribution; support of websites or online resources for the program; and commonly for NHLBI awardees, management and distribution of protocol dollars.

Since DCCs play a pivotal role in coordinating and executing large, expensive clinical trial programs, it is imperative that NHLBI identify and require best practices for DCCs funded to support these programs. Ensuring we have quality DCCs will require that we:

• Understand the current capability of DCCs.
• Identify minimum requirements for a DCC to support a large clinical program.
• Adopt best practices that all DCCs should follow.
• Understand the costs associated with specific functions or practices.