Biomarkers – Minimum Standards Initiative Working Group Dinner Session

Chairs: Steven Potkin, MD; Don Goff, MD

The Biomarkers Working Group will primarily focus on biomarkers associated with schizophrenia. It has completed its work on imaging biomarkers and will now address non-imaging biomarkers in schizophrenia, and an additional focus on minimum standards.

The FDA is developing a list of minimum standards for submitting and reporting clinical trials. The lack of minimum standards of information has limited the development of generalizable biomarkers and hampered meta-analyses. The ISCTM Biomarkers Working Group dinner will develop input based on its methodological experience to support the FDA in their work on the minimum standards initiative.