04/02/2024
Photo By Jason Goodman on Unsplash
The US Food and Drug Administration (FDA) published guidance on “Use of Data Monitoring Committees in Clinical Trials” in February 2024 which, once finalized, will take precedent over the FDA’s previous guide on the subject from 2006. The guidance clarifies data monitoring committees’ (DMC) relevance and importance in clinical trial oversight, and how to determine when utilizing a DMC is practical for certain clinical trials.
The majority of the facts and definitions surrounding DMCs have stayed the same from the 2006 guide to 2024:
One of the primary purposes of a DMC has always been ensuring patient safety in clinical trials, especially those that pose significant risk to the participant, data integrity/validity, blinded trials, and when there isa potential for bias.
It is still required that DMCs be composed of members who have relative experience and expertise in the industry, have no financial or intellectual conflicts of interest, and at least one member who is a statistics expert.
It is still encouraged that DMCs have predefined access to interim data to evaluate patient’s safety throughout the trial by identifying trends in any serious adverse events while ensuring that the those involved in the study (sponsors, investigators, patients) remain blinded to preserve the data integrity.
Effectiveness of an investigational product (IP) or device as well as the futility of a trial or its likelihood of success if run to completion can also be evaluated by DMCs with access to interim data.
Based on the interim data evaluations, DMCs may also make recommendations to the sponsor about early termination of the trial, if patient safety is at risk, if the interim data shows no benefit for the IP or device, or if there is external data that would suggest futility or success for the trial.
The DMC should always remain as independent as possible from the conduct of the trial, allowing access only to enough trial/interim data that will allow them to make informed decisions to bolster patient safety but not enough data that could allow biases.
Nuances to DMC structure and responsibility found in the 2024 guide include:
The increased use of DMCs in trials of modest size. The FDA does not require a DMC be used in each trial, however, for larger sized trials with longer time periods, if the sponsor is inexperienced in clinical trials, or if the trial subjects are of a vulnerable population, the FDA strongly recommends the sponsor use a DMC.
Having DMCs oversee entire developmental programs as opposed to individual clinical trials is a new trend that gives DMCs more information about an IP or device which allows them to make more informed decisions about patient safety how the trial should proceed.
A trend for longer and more detailed DMC charters that clearly define the responsibilities of its members including member selection, schedules, analyses of interim data, and how the confidentiality and credibility of data will be maintained. The more detail that is provided in the charter the less chance of subject confidentiality being broken or bias being introduced through the sponsor or investigators having access to unblinded data.
A full list of significant changes is provided in the 2024 guide as well as all responsibilities of DMCs and other oversight groups. Comments about the guidance can be submitted now through to April 15th, 2024 here. Could a DMC help you with how you conduct your trials or would it impede your trial progress? We would love to hear from you!
-The Clinical Pathways Team
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