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# Master Protocol Guide for Covid Therapies
- URL: https://www.fdaweb.com/master-protocol-guide-for-covid-therapies/
- Published: 2021-05-17T12:00:00.000Z
- Updated: 2026-09-14T16:59:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149331

FDA has issued a final guidance entitled [*COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention Guidance for Industry*](https://u7061146.ct.sendgrid.net/ls/click?upn=fnjKVEtEq7-2F-2B3m6pq3DC0C9Lk5A-2B33xuTsmrUm-2F-2F7Refpu78IolQnQq2EsuijLR-2FLfIaiY9raTsHS0z-2BmT7HeQK-2BCQSiG74kyriK2KTDuDeZhs-2Bqydj4eF2KWfe6nQv5alsUqklzbAZ0IOpAXNaLkI6VSx6vHXhV93IGznjMbUcpeGjTZzMS6-2Fue4K-2BYXdnPJN5cY7Mc2AJCMbGJ41HrV1dhEdEnwgPNNHeC7-2Bgw7Jr3FvcyKwuhp7cARGogaECIXKZ5zHb6rJBml8BuQHFuuFkYtpG3FrBb99ZWBZEirJeIScm12vBJpEvKDbf7rUINrtuX-2F683MD4vVtjMdoMK7Ei4PoPLoaUDTQAhT1an7cjJYuNhv75-2B-2FIPHKclKATnmSST-2FijKdYi9oSkoHnOIAXoTqAMN-2F8Jj1iKh5IOgN-2FkpZfwcdqVQ2kwMKBE0gdjRuCcRtnAq1HOCFomSR4AMBGkHZRoAUZssrIIaXpXaDnlOBiCHaomPIB4qRbN96izv9kcDJV3AMU-2FtW-2B3eqvKijDiDWNIHrBZHZ7yAdTVPtrav0WqzfgIFkkdEgilbWCNHJ7bzF3P5urvgJZd96NEhGoUw4oozuKoaAWWb0UIOvlTNOHqBUQFWviQdHP8b0VYO4h7CnM2t2Fjhnw20Yvb9hX-2BTZkLtMNQoIqZlCUblRC-2Bsu8ucvJuSx-2BDWtkUTM6sIBV9-2BAJKSHC9HGL-2BLKBB8C6jkdG5UeeHQ6PjBMpqUJCrOrQzWj9w6f40-2BMxu-2B61XMtTTRX%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLIZH-2BlHUpIN1Fpx16wXLzBItZQB-2B865N-2BRM-2FfR3UV9b-2BzD8pZSEDjr63FamAR-2FX-2BMVAfbB3v5DcJRJ8M7ABbOOU3rJrNv8UB-2FOHTBAkRGXukuJwfrAI4Ty3UYF8TJPRVEG1uh2XXnK3zeqUlYQtio2rHTKZmPQVfEhMAXpKultPrghoRpFqnyDAvy-2BX0xn-2F-2B0L3pPl7Axg9NnqOBvMQpvsFKPpMic9dVfvp6LoxogRHfsLKgs2txf1iFK6lR6nbVrnvhPDn5vEZJSGby3EugullPAiN5S1LyZPdFmeKaa-2Br9A-3D-3D&ref=fdaweb.com). The document provides recommendations on master protocols evaluating drugs for treating or preventing Covid-19\. An agency notice defines a master protocol as a “protocol designed with multiple substudies, which involve coordinated efforts to evaluate one or more investigational drugs, in one or more disease subtypes, with one or more objectives, all within the same overall trial structure.” The guidance also addresses trial design, conduct, and statistical considerations for master protocols. Additionally, it provides administrative and procedural recommendations for such protocols.

Master protocol use has been a pet project for FDA acting commissioner **Janet Woodcock** for several years. Writing in a 2017 *New England Journal of Medicine* [article](http://www.nejm.org/doi/full/10.1056/NEJMra1510062?ref=fdaweb.com), then-CDER director Woodcock and Office of Biostatistics director **Lisa LaVange** advocated for more use of master protocols for “precision medicine” trials to evaluate targeted therapies. They contended that the move to such protocols is needed because the “standard approach to generating this evidence — a series of clinical trials, each investigating one or two interventions in a single disease — has become ever more expensive and challenging to execute.”

At the time, the FDA officials said a master protocol “may involve direct comparisons of competing therapies or be structured to evaluate, in parallel, different therapies relative to their respective controls. Some take advantage of existing infrastructure to capitalize on similarities among trials, whereas others involve setting up a new trial network specific to the master protocol. All require intensive pretrial discussion among sponsors contributing therapies for evaluation and parties involved in the conduct and governance of the trials to ensure that issues surrounding data use, publication rights, and the timing of regulatory submissions are addressed and resolved before the start of the trial.”

In 2018, CDER issued a general draft guidance cancer drug [master protocols](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM621817.pdf?ref=fdaweb.com) that proposed principles for modernizing such clinical trials. It provided recommendations to cancer drug sponsors on the design and conduct of clinical trials intended to simultaneously evaluate more than one investigational drug or more than one cancer type within the same overall trial structure. It also described aspects of master protocol designs and trial conduct and related considerations, such as biomarker co-development and statistical analysis considerations, and provides advice on the information that sponsors should submit to FDA and on how sponsors can interact with the agency to facilitate efficient reviews.