*Advancing Adaptive Trial Design Methodology

Past New Requirement Updated

Agency
Solicitation expected
Estimated value
$700,000 to $1,500,000
Set-aside
No set-aside

Forecast facts

Anticipated award
NAICS code
Not on record
Points of contact

Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.

About this forecast

The Food and Drug Administration is procuring services to develop, standardize, and implement advanced adaptive trial design methodology across three priority areas: Bayesian prior specification and sensitivity analysis frameworks, adaptive trial design applications in rare disease and medical device development, and principled single-arm trial design with robust inferential standards. The estimated solicitation release date is July 1, 2026, with an estimated award date of January 1, 2027.

The estimated award value ranges from $700,000 to $1.5 million. Questions and inquiries should be directed to the FDA's Contracting Officer at cdhracquisitions@fda.hhs.gov.

Forecast text

Provide a description of the investment and the desired outcome. This initiative supports the development, standardization, and implementation of advanced adaptive trial design methodology across three priority areas:(1) Bayesian prior specification and sensitivity analysis frameworks, (2) adaptive trial design applications in rare disease and medical device development, and (3) principled single-arm trial design with robust inferential standards.

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