Precision Medicine NCPTSD (VA-24-00060494)

Background
The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), National Center for Posttraumatic Stress Disorder (NCPTSD) was established in 1989 to address the needs of Veterans with military-related PTSD. The mission of the NCPTSD is to enhance clinical care and social welfare for Veterans through research, education, and training in PTSD treatment.

The NCPTSD's precision medicine workgroup aims to construct a Person-level Clinical Trial Database (PCTD) to aggregate datasets from multiple PTSD clinical trials and conduct Meta-Analysis of Individual Patient Data (MIPD) to improve precision treatment for PTSD. This initiative is crucial as numerous clinical trials are ongoing and expected in the future, necessitating a repository that can accommodate periodic updates with new trial datasets.

Work Details
The Contractor shall design and construct a harmonized and updateable Person-level Clinical Trial Database (PCTD) suitable for archiving and analyzing individual-level patient data from PTSD clinical trials. Key components include:
1. A harmonized PCTD hosted on Government IT systems;
2. Procedures for transfer, storage, and use of deidentified clinical trial datasets;
3. Harmonization procedures for transforming datasets into suitable formats;
4. Analysis procedures for integrative data analysis (IDA) and meta-analysis of individual participant data (MIPD);
5. Incremental expansion plans for the PCTD;
6. Training for NCPTSD research staff on using the repository effectively.

Deliverables include Pilot Phase Trial Selection Report and Expansion Phase Trial Selection Reports, along with a Common Data Elements Report detailing clinical trial measures suitable for inclusion in the data repository.

Period of Performance
The Period of Performance is set at 12 months from the date of award, with four optional 12-month periods, totaling a maximum of 60 months.

Place of Performance
Tasks will be performed at Contractor facilities as identified in their proposal.