We will selectively include calls for public consultation from multilateral agencies, governments, INGOs and other sources where there is a clear intersection with consent/assent. This might be obvious from the title of the draft guidance, regulations, etc., but more often, it will be a thematic area or topic – if properly addressed at all. If you would like to explore participation with our working group developing submissions for these calls, please contact us [david.r.curry@ge2p2global.org].
Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability
Food and Drug Administration, HHS.
Scheduled Pub. Date: 12/22/2023 FR Document: 2023-28210 PDF: https://downloads.regulations.gov/FDA-2023-D-5259-0002/attachment_1.pdf 8 Pages (109 KB)
Submit either electronic or written comments on the draft guidance by February 20, 2024
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Master Protocols for Drug and Biological Product Development.” The draft guidance addresses the design and analysis of trials conducted under a master protocol as well as the submission of documentation to support regulatory review. The primary focus is on randomized umbrella and platform trials that are intended to contribute to a demonstration of safety and substantial evidence of effectiveness. The considerations in this guidance apply to a range of therapeutic areas. The draft guidance is intended to clarify the Agency’s thinking on the use of master protocols in drug and biological product development, which was previously addressed in FDA’s guidance entitled “COVID–19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention.” FDA is also announcing the withdrawal of the guidance entitled “COVID–19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention.
Excerpt
250 C. Informed Consent
252 The informed consent process should cover all treatment arms in the trial to which the subject
252 could be randomized.13,14 In a platform trial allowing drugs to enter and leave the trial over time,
253 the consent form should be modified over time to reflect the drugs currently under evaluation…
256 The informed consent process should occur prior to a subject’s randomization and avoid
256 substudy-specific consent. Consent that occurs after subjects have been randomized to one of the
257 substudies may result in subjects with different prognostic characteristics across substudies,
258 raising concern about the comparability of each drug group with the shared control group
259 (comprised of control subjects from different substudies). To illustrate the concern, consider a
260 master protocol with two drugs (drug A and drug B) in which the subject consents to screening
261 and randomization to a substudy as part of the master protocol, with a substudy-specific
262 informed consent process to occur after randomization to that substudy; after the substudy-
263 specific consent, the subject is then randomized to the drug or its matched control. With this
264 process, comparing drug A against the shared control arm (including subjects who received
265 either control for drug A or control for drug B) may result in noncomparable groups if subjects
266 who would consent to participating in the drug A substudy differ from subjects who would
267 consent to participating in the drug B substudy.
13 Some consent processes allow a subject to be randomized in the trial even if the subject only consents to a subset of the drugs under evaluation; under such a process, subjects should not have the potential to be randomized to drugs for which they do not consent.
14 See the guidance for IRBs, Clinical Investigators, and Sponsors Informed Consent (August 2023).
Center for Informed Consent Integrity 