Dawn L. Hershman, MD, an oncologist from Columbia University, shared insight into the current challenge of ensuring drug adherence within clinical trials and how this adherence can impact the quality of care for patients in real-world settings.
Dawn L Hershman, MD, an American Cancer Society Professor of Medicine and Epidemiology and the Director of Breast Oncology and coleader of the Cancer Population Science program at the Herbert Irving Comprehensive Cancer Center at Columbia University, expressed that there is no perfect way to assess drug adherence, but it's essential to improve it in clinical trials to ensure that patients in the real world are adequately aware of toxicity risks.
How big is the issue of ensuring participant drug adherence within clinical trials? How often are trials compromised because of drug adherence issues?
We know that whether patients are in clinical trials or not on clinical trials, adherence is a huge issue. And in oncology, we've become increasingly aware of it as we have more and more oral medications that we rely on patients to take.
The patients on clinical trials are the best of the best in terms of adherence because they are patients that have agreed to participate in a trial. And yet, we still see low rates of medication adherence or high discontinuation rates overall. We've seen in some of the most recent trials 40% or 35% of complete discontinuation rates before the trial has completed, let alone knowing what patients are taking intermittently because often that's not measured.
So, many trials look to see whether or not discontinuation affected the outcome—ie, did patients who were compliant do better? The studies aren't often powered that way and so you may draw the wrong conclusions if you don't adequately power or take into account the discontinuation rates of those medications.
What steps can researchers take to help improve drug adherence when conducting clinical trials?
That's a great question. The vast majority of the time patients discontinue their medications, it's because of side effects. So, really making sure that we have a good understanding of the side effects and can mitigate any side effects that come up is really critically important. So, having those tools.
Clinical trials are a step ahead of the game because they're providing the drug. Many patients in the community are nonadherent because they don't have access to the medicine or they can't afford the co-payment. There are lots of studies underway in terms of using digital media in order to help patients keep track of what they're taking and when they're taking it.
But at the end of the day, good support and constant communication are probably the best measures and then making sure that we're really adequately measuring these outcomes in the clinical trials. And it's important not just to measure the adherence to the drug being studied, but what's happening to the other medications that patients are taking as well.
How can improving drug adherence within clinical testing impact patients’ quality of care, especially in the oncology sector?
Right, well, we know that, as I said before, clinical trial patients are the best of the best, but then you start to have many more barriers to care in the community where patients have more comorbidities or they're on multiple medications. Obviously, we have to pay attention to drug-drug interactions when these medicines are disseminated into the community. But really trying to understand it and understand the strategies that work while the trials are being conducted so that providers and patients have that information when they start to take the medication is important because many patients discontinue medicines almost immediately. And we've seen that with other drugs, that people vote with their feet. So, if the toxicities are high, patients won't take them. It's hard to play catch up. So, we sort of have to know ahead of the time that we do the larger trials, what's going to work.