VA RFI: National Center for Posttraumatic Stress Disorder (NC-PTSD) Precision Medicine Work Group Person-level Clinical Trial Database (PCTD)

Notice ID: 36C10B24Q0664

The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), National Center for Posttraumatic Stress Disorder (NC-PTSD) precision medicine workgroup has identified an overall need to construct a Person-level Clinical Trial Database (PCTD), establish collaborative relationships with PTSD clinical trial sites, aggregate and harmonize datasets from multiple PTSD clinical trials, and carry out Meta-Analysis of Individual Patient Data (MIPD), in order to advance research in precision treatment for PTSD. PTSD treatment is an active area of research with numerous clinical trials currently underway and expected in the future. For precision medicine research conducted by the NCPTSD to stay current with the PTSD treatment evidence base, that repository’s contents and the associated analysis procedures must be designed to accommodate periodic updates with new trial datasets. Because carrying out these tasks appropriately requires close involvement from NCPTSD’s scientific experts, the NCPTSD staff also need to develop scientific and technical understanding of all phases of this process.

1. A PCTD capable of aggregating and archiving datasets from multiple PTSD clinical trials
2. Effective processes for data management, administration, and transfer for clinical trial datasets
3. Technical methods to harmonize PTSD treatment data across trials.
4. Technical methods to conduct individual patient data meta-analysis
5. Plans and methods for phased updates to the repository to reflect ongoing research
6. Training to develop NCPTSD internal expertise in data aggregation and analysis techniques.

The Contractor shall provide tailored delivery of evidence-supporting PTSD treatments based on individual patient needs to achieve improved treatment outcomes.  The requirements of the NCPTSD Program Office are to have:

1. A Person-level Clinical Trial Database (PCTD) capable of aggregating and archiving datasets from multiple PTSD clinical trials.
2. Expertise in establishing collaborative relationships and negotiating data use agreements with clinical trial sites for meta-analytic research.
3. Effective processes for data management, administration, and transfer for clinical trial datasets.
4. Technical methods to harmonize PTSD treatment data across trials and perform integrative data analysis (IDA).
5. Technical methods to conduct meta-analysis of individual participant data (MIPD).
6. Plans and methods for phased updates to the repository to reflect ongoing research.
7. Training to develop NCPTSD internal scientific and technical expertise in the assembling, maintaining and expanding a PCTD, and in carrying out IDA and MIPD procedures.

The period of performance shall be a 12-month base period with 4 (four) 12-month option periods and optional tasks.

The Contractor shall design and construct a harmonized and updateable PCTD for PTSD clinical trials, which includes development of associated analysis procedures, and training for NCPTSD research staff in using the repository.

Read more here.

🔊 Listen to Story