The Power of Independent Data Monitoring Committees Is Diminishing

Kathy D. Miller, MD


May 05, 2021

This transcript has been edited for clarity.

This is Dr Kathy Miller from Indiana University. Today I want to discuss a subject that's been on my mind lately: the important role of independent data monitoring committees (IDMCs). I'm getting older as an investigator and that means I am more frequently asked to join IDMCs and serve the clinical research community and our patients in that way. That service has got me thinking about this critical role. I've seen several developments recently that raise concerns to me as an investigator, as someone who treats patients, and as someone who serves on IDMCs.

I've started to see an erosion of the power of IDMCs to be that crucial checkpoint for patient safety and for making sure that results of trials are not released before they're ready, when we haven't arrived at an answer we can trust and put our faith in. I have to say that I was particularly distressed to see the US Food and Drug Administration (FDA) release the results of an ongoing phase 3 trial when those results had not yet been issued by the IDMC.

Now, I appreciate the FDA's role in evaluating the safety and the efficacy of potential new therapies, and I know they take that role seriously. But if the IDMC didn't okay that data for public release because that data had not yet reached a threshold that could reliably be used to make decisions about treatment, then I believe it was a disservice to all of us to have that data released publicly by another group. I also wonder about the impact of that public release of the data on the study itself. If patients or their treating physicians start making decisions based on premature data, we may decrease our ability to answer the question the study was designed to evaluate.

I've seen other issues with IDMCs lately that raise the same concern. IDMCs no longer have the power to stop a study. They make a recommendation, and then a sponsor or a steering committee has to accept that recommendation. But I've seen steering committees initially refuse to accept the recommendation unless they were shown the blinded data on which the IDMC's recommendation was based. All of these things raise my concerns that in our goal of getting new medicines to patients sooner, maybe starting to cut some corners could cause problems — problems for our patients and problems for our own confidence in the safety, reliability, and efficacy of the medicines we so desperately want and our patients deserve.

Next time you participate in a trial, next time you review that data, think about that important role. If you know someone who has served on an IDMC, give them a thumbs-up and a thank you. This is Dr Kathy Miller. I'll see you again soon.

Kathy D. Miller, MD, is associate director of clinical research and co-director of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University. Her career has combined both laboratory and clinical research in breast cancer.

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