2024 Trends in Clinical Trials: Q&A With Ken Getz of Tufts and Jim Murphy, CEO of Greenphire
Following a webinar on what the clinical trials space will look like for the remainder of 2024, ACT caught up with Getz and Murphy to discuss their biggest takeaways.
On February 22, Greenphire hosted a webinar on upcoming trends in the clinical trials space in 2024. Moderated by Tim Dorsey, team lead, product training at Greenphire, the participants were Ken Getz, executive director and professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, and founder and board chair, CISCRP; and Jim Murphy, CEO at Greenphire.
The panel discussed a variety of topics including new trends in protocol design, patient centricity, and decentralized clinical trials (DCTs). Following the webinar, Applied Clinical Trials caught up with Getz and Murphy to discuss their thoughts on some of these emerging areas.
ACT: What do you think were some of the biggest takeaways from the discussion?
Jim Murphy: Ken and I discussed a lot of challenges and opportunities for clinical trials, but there are a few areas we both expect to see a lot more discussion on throughout 2024:
- Challenges and innovations in drug development
- Despite an increase in the number of drug approvals, there is a notable decline in overall success rates, which is an interesting and complicated scenario. Success rates have diminished but there are many more studies for many more compounds than two decades ago. There are an increasing number of therapies approved, on top of the tremendous number of effective treatments already available. We are living in a golden age of innovation. The importance of adopting new strategies and technologies—such as risk-sharing models, public-private partnerships and the use of real-world evidence—is crucial to reverse some of the trends of high average costs per trial and per compound and, ultimately, enhance trial efficiency and improve the overall success rates of drug development programs.
- Increasing protocol complexities
- We’re continuing to see an increase in clinical trial protocol complexities that are related to two things: 1) The science of clinical research, which is leading to more targeted therapies, but it is making recruitment and participation burden increase as it requires searching for a more specific patient and 2) As protocol design becomes more complex, with more endpoints, sites and technologies, it’s going to become increasingly more challenging to maximize the information gained from each participant.
- A way to measure the economic, efficiency and performance impacts of burdens on sites and patients
- Patient burden, including time spent and travel distance, is a critical consideration that impacts participation rates, especially in areas like oncology where the average travel distance is significant and growing. This underscores the need for more strategies to reduce patient burden, such as hybrid models. But efforts to alleviate burden for trial participants often end up shifting the burden to other parties, particularly investigative sites. There is also a need for a more sophisticated approach to understanding and really measuring patient burden to optimize trial execution while minimizing burden for everyone.
ACT: What trends are being observed in relation to study enrollment and participation?
Murphy: Enrollment isn’t growing proportionally to the number of studies, but there truly is no better time than now to participate in clinical trials. Science is advancing quickly and both the number of trials as well as the proportion of trials involving targeted therapies are increasing. As a result, the likelihood of there being a trial that could serve as a viable care option has never been greater. The conversation of low enrollment often centers around financial, logistical and time-related impediments, all of which remain formidable challenges; however, another factor that we don’t always address is the challenge of awareness.
Ken Getz: We’re facing a lot of “last-mile” issues. There is a large volume of trials, but there are a lot of barriers that prevent this great volume from providing realistic options for patients. For example, there are many sites that are ready to respond to patient inquiry, but some rely on call centers that take days to respond. Even more importantly, many patients are never asked nor told there may be a trial of interest to them.
ACT: It was also discussed how much work happens behind the scenes when it comes to the complexity of protocols and simplifying them for patients. Do you think patients should be more informed on how studies are being designed? If so, how can we achieve that?
Murphy: While complex, the industry can do more to educate participants to understand what actions are needed to manage and protect the quality of trial data. That’s part of a partnership that we haven’t really focused on nor emphasized with patients.
Getz: We all know that the science of clinical research has advanced. The diseases we’re studying are more complicated and it’s harder to demonstrate safety and efficacy, especially when we’re targeting ever more narrowly defined patient populations and difficult to evaluate diseases. Then you add in operational complexity. We’re trying to make it all seem so easy and convenient for the patient, but what’s going on behind the scenes requires more funding and more parties and more creativity. I’m hopeful that we’ll get better at that in the future.
ACT: How do we find a balance between reducing patient burden and keeping site burden to a minimum?
Getz: Typically, the burden of trial execution doesn’t ever go away, it’s simply displaced to another party. A great example of this is when we started to embrace remote monitoring. We saw that it relieved some of the workload of our field monitors, but suddenly the sites had more work to do. Same with DCT, in which sites juggle multiple technologies and solutions simultaneously. The typical site often must remember upwards of 20 different passwords just to get into all the different systems that are in the back end of one single trial! This burden displacement can affect site efficiency and performance.
To achieve balance, we need a more sophisticated approach to understanding and addressing burden. We assume that burden for patients and burden for sites is uniform, but a novice site may feel the burden differently than an experienced site, for example. Sponsors must understand how to measure, assess and accommodate individual site burden. We must also optimize areas in the clinical trial that will help ease the economic impact of burden. For example, in moving a trial into a clinical care setting, you’re leveraging the clinical care infrastructure and perhaps even running the trial at the routine point of care for the patient. Obviously, we’re now transferring some burden into the care setting, but this model does hold promise for reducing economic burden. We just haven’t seen measurable results yet.
Murphy: Overall, burden shift is a challenge; however, innovative technology, in combination with flexible operational support solutions, make it possible to engineer administrative burden out of the process, not just shift it from the patient to the site.
