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# Improvements to FDA Adaptive Design Guidance Praised
- URL: https://www.fdaweb.com/improvements-to-fda-adaptive-design-guidance-praised/
- Published: 2018-12-05T12:00:00.000Z
- Updated: 2026-09-15T00:48:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142969

Pharmaceutical Research and Manufacturers of America says it “commends FDA on the improvements that have been made” in the agency’s draft guidance on adaptive designs for clinical trials of drugs and biologics over the 2010 guidance. Its comment [letter](https://www.regulations.gov/document?D=FDA-2018-D-3124-0022&ref=fdaweb.com) says the current draft “provides clear recommendations for complex design simulation and result reporting, which will be very helpful for future clinical trial design planning.” The association also provides specific line-by-line comments.

In its [letter](https://www.regulations.gov/document?D=FDA-2018-D-3124-0014&ref=fdaweb.com), Novartis raises for clarification general issues involving statistical approaches, terminology such as “specific adaptive rule” and “specific algorithm,” and quantification of and adjustment for bias in point and interval estimates. The company also offers line-by-line comments.