The STRONG STAR adverse events monitoring program for psychological health clinical trials

The monitoring of adverse events is a well-established practice for clinical trials evaluating medications and medical devices. However, most psychological health and psychotherapy clinical trials either do not report or limit adverse event monitoring to serious adverse events such as suicide attempts and psychiatric hospitalizations. Some potential adverse events, such as temporary increases in anxiety, are often considered to be a normal part of psychotherapy and therefore may not be documented as adverse events. Without systematic and comprehensive reporting of adverse events, investigators and patients will never know the frequency or severity of problems encountered by patients and/or attributable to the therapy/treatment provided. The South Texas Research Organizational Network Guiding Studies on Trauma and Resilience (STRONG STAR Consortium) established a program for the routine reporting of adverse events or untoward changes in health for psychological health clinical trials that has been in use since the inception of the consortium. The adverse events monitoring program meets the Codes of Federal Regulations for human subjects research, International Conference on Harmonization, and good clinical practice guidelines for the assessment and documentation of possible adverse events in clinical trials. This manuscript outlines the STRONG STAR Adverse Events Monitoring Program for psychological health clinical trials including (1) the definitions of key terms, (2) the STRONG STAR approach to monitoring psychological health adverse events, (3) the processes and procedures of reporting, (4) an example of reporting, and (5) a call for standardized monitoring of adverse events as a routine practice in psychological health clinical trials.