2019 Annual Report: Traditional Trials


Michael Felker, MD, MHS, a cardiologist at the DCRI, invited his colleague, fellow DCRI cardiologist Adrian Hernandez, MD, MHS, to discuss the evolving clinical research landscape and how the DCRI is responding by continuing to deliver traditional clinical trials while also incorporating pragmatic approaches.

MICHAEL: It seems like we’re at an inflection point in clinical research, from an era where we were focused on randomized clinical trials as the foundational way of generating evidence to now, where there are all these additional aspects of evidence generation, such as real-world data, pragmatic trials, and registry-based trials. I think it’s created interesting opportunities, as well as interesting challenges. Adrian, how do you view the current landscape?

ADRIAN: There are two things at play. The complexity and cost of trials have increased. On the other hand, we need more answers to important questions. Alongside that, we’ve seen a transformation in health care systems in terms of greater access to data and greater engagement of patients, which gives us the ability to take advantage of that for research purposes and hopefully make research simpler.

MICHAEL: Agreed. This transformation, particularly in terms of data access, is interesting. As you know well, the way we collect data clinically is often not structured for the data to be used for research. But it seems like a real opportunity, especially in a big health system like Duke, to have a learning health system where we’re actually testing questions and learning from the way we conduct clinical practice.

ADRIAN: That’s exactly right. As health care systems get smarter about care delivery, how do we embed research within the health care systems to power clinical trials? For certain outcomes, what we need as researchers is already available in the clinical care setting.

But there may be other things that we need to do more in a traditional mode or directly with patients to collect certain information that isn’t part of routine care. That’s where things have to be hybridized, combining traditional aspects with more pragmatic approaches that leverage what’s being done as part of clinical care.

MICHAEL: A lot of these more pragmatic approaches have the potential to address some of the challenges we’ve seen in traditional trials—expense, as you mentioned, slow enrollment, and very long timelines. Do you think the traditional Phase 3 randomized clinical trial is on its way out, or do you think there’s always going to be a role for that kind of evidence generation?

ADRIAN: I think one of the things we’ve learned is that one size does not fit all. There is a spectrum of discovery as we learn about a condition or a novel therapy, and we want to know everything about it before it reaches the public. For clinical developments, we’re still going to need lots of information about what’s happening in the progression through Phase 1 to Phase 3 trials. But as we have more information, we can narrow down and take advantage of more pragmatic approaches, with a special focus on methods that will be more convenient for patients.

MICHAEL: I think we’ve realized it’s not a strict dichotomy between traditional and pragmatic. Even for trials that are traditionally structured, there are a lot of opportunities to leverage other data sources to identify patients, conduct follow-up, or otherwise streamline trials so we can get answers more quickly for our patients.

This is a place where the DCRI can really add value because we have expertise across not only traditional clinical trials, but also a lot of these new technologies like wearables, real-world data, and learning health systems. The ability to bring all of that together in one place will be critical as clinical research moves forward.

This article originally appeared in the DCRI's 2018-2019 Annual Report. View more articles from this publication.

DCRI cardiologists Michael Felker, MD, and Adrian Hernandez, MD, discuss different types of evidence generation, from traditional randomized trials to pragmatic clinical trials that embed research in routine patient care.