Drug Re-purposing for Effective Alzheimer's Medicines (DREAM) Study

SOLICITATION 75N95019R00055 ATTACHED TO THIS NOTICE.

QUESTIONS (NO MORE THAN 5) DUE: 3:00 PM on July 18, 2019.

PROPOSALS DUE: 5:00PM on August 4, 2019.

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PRE-SOLICITATION NOTICE OF INTENT

INTRODUCTION
PURSUANT TO FAR Subpart 5.2-Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION.

The National Institute on Drug Abuse (NIDA), Office of Acquisition, Contracts Management Branch Blue on behalf of the National Institute on Aging (NIA) intends to negotiate and award a contract for a service entitled "Drug Repurposing for Effective Alzheimer's Medicines (DREAM)"

EXTENT OF COMPETITION
This acquisition is full and open with no set-aside restrictions
NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE
The intended procurement is classified under NAICS code 541990 with a Size Standard of $15.0 million.

REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2019 dated January 22, 2019.

This acquisition is conducted under the procedures as prescribed in FAR Subpart 15-Contracting by Negotiation.

DESCRIPTION OF REQUIREMENT

Project Description
There is an urgent need to discover effective treatments for Alzheimer's Disease (AD) which currently affects more than five million Americans. Original research performed in the Unit of Clinical and Translational Neuroscience, NIA Intramural Research Program (IRP) has identified several commonly used medications that may protect against AD. The purpose of the project is to perform data analysis to confirm whether these drugs protect against AD.

Purpose and Objectives
The main objective of the requirement is (but not limited) to:

Perform data analyses on large electronic health record (EHR) and/or medical insurance claims data containing drug prescription information, demographic characteristics and clinical outcomes to test whether exposure to specific drugs (approximately 20 drugs to be disclosed by NIA IRP and referred to as 'NIA-AD drug list' hereafter) are associated with altered risk of incident AD and dementia. It is expected that approximately 10 drugs each will be tested in the base year and option year.
Technical requirements
1. The primary datasets to be used for the analyses are to include: i) Medicare fee-for-service Part D claims data and/or ii) Clinical Practice Research Datalink (CPRD). The contractor will provide evidence of exisiting access to the datasets including approvals required to use the data for the proposed analyses.
2. The contractor shall provide evidence of prior work using the specific datasets indicated above in analyses similar to those described below. The contractor shall also provide evidence for resources and personnel available to complete analyses of 20 drugs in total over 2 years (as described below in "DELIVERY OR DELIVERABLES." The contractor must also have prior experience working on similar data analyses projects as a contractor with government entities (e.g., FDA, National Institutes, PCORI, etc.)
3. The contractor shall provide a detailed analytical plan describing the proposed study design (eg: matched case-control, retrospective cohort study, etc) with clear explanation of the rationale. This plan should include details about the validity of AD/dementia diagnoses, definitions of drug exposures (eg: in matched users and non-users) and outcomes including a detailed description of potential confounding variables. Details should be provided on how confounding by indication will be addressed by methods such as propensity score matching.
4. The analytical plan should address how immortal time bias will be addressed by using methods such as time-varying exposures.
5. The analytical plan should include a detailed description of the statistical methods that will be used to assess differential risk of AD/dementia between the exposed/user and non-exposed/non-user groups. It should describe how competing risks will be addressed by methods such as 'Fine and Gray' models. The use of robust variance estimators that account for clustering within matched sets must be addressed.
6. The differential risk of incident AD/dementia between exposed exposed/user and non-exposed/non-user groups must be clearly summarized by appropriate metrics such as Kaplan-Meier plots.

Period of Performance
One Base Year beginning on or about August 1, 2019 - July 31, 2019 with one additional one-year option period.

CLOSING STATEMENT

The solicitation will be issued on or about June 10, 2019, and bids or proposals will be tentatively due about 30 days after the solicitation release date.

Potential offerors may request a copy of the solicitation from the Jon Gottschalk electronically at jon.gottschalk@nih.gov and must reference the solicitation number 75N95019R00055, on your electronic request. FAX requests are not accepted.

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