Dr James Hamrick Outlines Challenges of Managing Clinical Trials and Benefits of Community Practices

The increasing complexity and personalization of clinical trials are major challenges for managing clinical trials, said James Hamrick, MD, MPH, Kaiser Permanente and Flatiron Health.

What is the biggest challenge you face in managing clinical trials?
First of all, to me, the practices in the community that invest in clinical trials really do understand that access to cutting-edge trials really is a hallmark of excellence in cancer care. And it really does take motivation from the practice because to run a clinical trial through your practice does require a significant deviation from your usual clinical workflow.

Some of the barriers that are increasingly happening in the community are the complexity of the trials—so it used to be that we had a straight-forward, traditional clinical trial on breast cancer patients, and now we’re dividing breasts cancer into further and further, more personalized cohorts. It may be an ER+ HER2- breast cancer in the metastatic setting. And that does a couple of things. One, it increases your complexity for your clinical staff; and 2, it makes the number of patients that are relevant to the trial smaller.

The increasing complexity of trials, the increasing personalization of trials, it’s a huge opportunity, and it introduces new efficiencies in terms of answering questions, but it’s also a challenge, especially in the community, for community practices, where they’re dealing with every different kind of cancer.

In addition, the same old challenge that we’ve had for years and years is that running a trial is simply a big disruption from your core workflow, which is the clinical care of patients. For a physician to transform what they’re doing for a specific patient from standard of care to a research protocol has been a very burdensome and time-consuming step, and that’s always going to be a headwind against which the practice is flying when they’re trying to participate in research.

I think there’s a huge opportunity for technology and smart smarter trial design to make the trials less disruptive to the clinical workflow. And with that I think we’ll see more accrual of patients.

What is the importance of utilizing community oncology practices when enrolling patients in clinical trials?
As we know, most of the oncology care in the United States happens out in the community, away from the large tertiary centers and you just have to have that population represented in your trials. We need trials that really represent the real world and that have more pragmatic designs. What I mean by that is they have somewhat looser inclusion/exclusion criteria; they allow the doctor to practice a little bit more the way they would in the real world with a patient that wasn’t on trial.

Because the traditional clinical trials do a great job of answering the question of “how do these medications work in the very restrictive population that they’re done in?” But we need to what happens when they’re released to the wild, so to speak. It’s really important that community practices be supported in conducting clinical research for oncology.
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