RFI for Precision Medicine Final.docx

REQUEST FOR INFORMATION

DEPARTMENT OF VETERANS AFFAIRS (VA) PRECISION MEDICINE

Introduction:

This is a Request for Information (RFI) only issued for conducting market research. Accordingly, this RFI constitutes neither a Request for Quote (RFQ), Request for Proposal (RFP), nor a guarantee that one will be issued by the Government in the future; furthermore, it does not commit the Government to contract for any services described herein. The Department of Veterans Affairs (VA) is not, at this time, seeking proposals or quotes, and therefore, will not accept, review, or evaluate unsolicited proposals or quotes received in response hereto. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted because of this request. The Government does not reimburse respondents for any costs associated with submission of the information being requested or reimburse expenses incurred for responses to this RFI. The information provided may be used by VA in developing its acquisition strategy and Performance Work Statement (PWS) or Product Description (PD). Any information submitted by respondents to this RFI is strictly voluntary; however, any information received shall become the property of the Government and will not be returned to the respondent. Interested parties are responsible for adequately marking proprietary, restricted, or competition sensitive information contained in their response. This is a request for information and does not obligate the Government in any way, nor does it commit the Government to any specific course of action. Product information, brochures, part numbers, and/or other description information may be included with the submission.

Requirement:

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.

Specific requirements include the following:

SCOPE OF WORK

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 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.

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

Responses:

Please submit a capability statement describing your company’s ability to meet the overall requirement described and responses to the questions below. The capability statement shall be limited to ten (10) pages. Responses to this RFI shall be submitted via email to Amanda Anderson at Amanda.anderson12@va.gov no later than 12:00 PM EST on August 1, 2024.

1) Provide a brief summary of your technical approach for meeting the requirements for Precision Medicine PCTD specific to the following:

a. Demonstrate experience and knowledge creation of a PCTD.

b. Demonstrate experience with data management, administration, and transfer for clinical trial datasets.

c. Demonstrate technical experience and functional knowledge of PTSD research and treatment.

d. Demonstrate scientific expertise in harmonizing PTSD treatment measures across clinical trials for the purpose of Integrative Data Analysis (IDA), through published peer-reviewed scientific articles and history of competitive grant funding.

e. Demonstrate scientific expertise in conducting Meta-analysis of Individual Participant Data (MIPD), including predicting Clinically Significant Change (CSC) for individual participants, through published peer-reviewed scientific articles and history of competitive grant funding.

f. Demonstrate experience with establishing collaborative relationships and negotiating data use agreements with clinical trial sites for meta-analytic research, as documented in published peer-reviewed publications and history of competitive grant funding.

g. Demonstrate ability to provide technical scientific training on IDA and MIPD, and an ability to train users on the maintaining the proposed PCTD.

2) Have the requirements, identified above, provided sufficient detail to describe the technical and functional requirements that encompass the desired solution?

______ YES ______ NO

a. If “NO”, please provide your technical and functional comments/recommendations on elements of the requirements, identified above, that may contribute to a more accurate quote submission and efficient, cost-effective solution.

3) Are there any specifications that you believe are unachievable by industry? If so, please state why.

4) What additional information would be needed to provide a firm fixed price quote for each item/task?

5) Include the following identification information:

a. Name of Company

b. Address

c. Point of Contact

d. Phone Number

e. Fax Number

f. Email address

g. CAGE code/Unique Entity Identifier

h. Company Business Size and Status for NAICS

i. Any Schedules held on General Services Administration (GSA), Government-Wide Acquisition Contracts (GWAC) held on the National Aeronautics and Space Administration (NASA) Solutions for Enterprise Wide Procurement (SEWP) V, or any other schedule not mentioned above to assist in determining acquisition strategy if you are included in one or more. Please also include Contract Number, expiration date, etc.

j. Socioeconomic data: If a small business, what type of small business are you? Are you able to comply with FAR 52.219-6 and 52.219-14 in execution of this effort? Are you able to comply with VAAR 852.219-10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside and with subcontracting limitations in 13 CFR 125.6 in execution of this effort?

6) Is your company currently providing similar services to any government agency or other non-government customers? If so, please identify the agency or non-government customer. If you are unwilling to share your customers' identity, please address whether your company offers the same or similar services, commercially (outside the federal government).

VA is requesting assistance in obtaining rough estimated pricing based on the implementation of a PCTD as identified in the requirements section. The results of the estimated pricing and technical capabilities shall be used to finalize the VAs requirements prior to issuing a solicitation. Please provide a Rough Order of Magnitude (ROM) for the product/solution being proposed if possible.

OFFERORS ARE ADVISED THAT THIS REQUIREMENT MAY BE DELAYED, CANCELED, OR REVISED AT ANY TIME.