Calibrating RWE studies in oncology against randomized trials

Active Definitive Contract Awarded Last action

Contract number
75F40122C00181
Awardee
Awarding agency
Obligated
$3,700,000

Award facts

Contract value 79% obligated
$4,691,150.00 Current and potential, with all options
Completion date 95% complete
Current and potential, with all options
Contracting staff
Set-aside
No set-aside
Competition
Full and Open Competition · 1 offer Basic Research
Pricing
Firm Fixed Price
Place of performance
Silver Spring, MD 20993, USA
Legislative mandates

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Funding Only Action P00002 · The purpose of this modification is to fund the remaining balance of the contract of $991,150.00 as referenced per far 52.232-18: $991,150
Other Administrative Action P00001 $0
Original award $2,708,850

About this award

The Food and Drug Administration (FDA) awarded a $4,691,150.00 firm fixed price contract to Brigham & Women's Hospital Inc. to conduct research on calibrating real-world evidence (RWE) studies in oncology against randomized clinical trials. The contract has a completion date of January 29, 2027 and does not have a small business set-aside designation. Brigham & Women's Hospital is a subsidiary of the larger Partners Healthcare System Incorporated, which is a major integrated healthcare system in Boston. Partners Healthcare and its subsidiaries have extensive experience conducting biomedical and clinical research across various specialties with support from federal contracts and grants. This contract aligns with the FDA's initiatives to leverage RWE to complement traditional randomized controlled trials for oncology product evaluations.

Subawards

Subcontractor Amount Awarded
Dana-Farber Cancer Institute, Inc. CALIBRATING RWE STUDIES IN ONCOLOGY AGAINST RANDOMIZED TRIALS Dr. Kenneth Kehl, a thoracic medical oncologist and researcher in the Division of Population… $134,159

Quick answers

Who was awarded contract 75F40122C00181?

75F40122C00181 was awarded to Brigham & Womens Hospital Inc. by Food and Drug Administration (Department of Health and Human Services) on September 21, 2022.

How much is contract 75F40122C00181 worth?

The government has obligated $3,700,000 on 75F40122C00181. Its current value, with exercised options, is $4,691,150.

Was contract 75F40122C00181 competed?

The extent of competition for 75F40122C00181 was full and open competition. The government received 1 offer.

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