A Primer for Conducting Mental Health Research in the Era of Clinical Trials

Background/Purpose: In 2015 the National Institute for Health (NIH) expanded its definition of Clinical Trials to include all intervention studies that randomly assign participants to treatment conditions and evaluate at least one biomedical or behavioral outcome.  However, little is known about how the reclassification of social and behavioral intervention research as clinical trials will impact study operations. This presentation will provide an overview of the monitoring and oversight procedures that have accompanied this reclassification and describe the impact these changes have had on study procedures in a study recently funded by NIMH.  

Methods:

Upon receipt of the initial award letter in April 2016, the current study was selected for a site visit by the NIMH Clinical Research Education, Support, and Training (CREST) Program. Initial CREST visits provide the PI and key study team members with education and technical support in the conduct of clinical trials research. Prior to the visit, study staff were provided materials that outlined NIMH expectations regarding required elements of clinical trials, including practices and procedures. Study staff cross-referenced materials for this visit with reporting requirements from NIMH yearly Research Performance Progress Report to develop a list of required study procedures needed to ensure clinical trial compliance.

Results:

This study’s designation as a Clinical Trial has had a significant impact on study operations. Required activities included registering the clinical trial online, creating and maintaining the study’s regulatory binder, adhering to recruitment milestone reporting and data sharing requirements, and ensuring that all study changes are approved horizontally (with the IRB) and vertically (with NIMH).  Initial online study registration must be completed before recruitment begins and kept up-to-date throughout the life of the study- a process that was complex and time-consuming. Additionally, all clinical trials must create a regulatory binder containing a number of documents new to mental health services research including,  a Delegation of Authority log, study protocol, manual of procedures, and procedures for documenting and reporting protocol deviations. NIMH policies on data sharing have evolved over the course of this project and require a data sharing agreement, which requires study data elements to be aligned with NIMH formats and uploaded to NIMH every 6 months. Data from NIH funded studies are now scheduled for release to the public 1 year after study completion.

Implications:

NIH’s efforts to enhance the precision of the information NIH collects, tracks, and reports on clinical trials have profound implications for social work intervention research. First, NIH’s efforts to standardize study procedures requires study management procedures to move from project specific management procedures to a standardized set of study tasks that have implications for study timelines and project staffing. Furthermore, data sharing agreements accelerate the timeline for publicly sharing data, requiring that study staff  to be timely in the analysis and publication of data. Increased focus on the standardization and reporting of project management activities has significant implications for how study staff spend time, which means more of the study budget must be dedicated to project management activities.