CWWeekly presents this feature as a way to put the spotlight on issues faced by executives in the clinical trials space. Kurt Mussina is vice president and general manager at Frenova Renal Research in Waltham, Mass.
Q: With one of the largest renal databases integrated as part of Fresenius Medical Care North America (FMCNA), a healthcare provider, what are some of the “real” protocol efficiencies and feasibilities—beyond faster startup—that provide speedier recruitment, thought leadership and quicker completion of clinical trials? Also, what are some of the concerns/limitations?
A: Real protocol efficiencies extend well beyond faster startup. With access to FMCNA’s data, we inform better clinical trial design. We can take a protocol’s inclusion/exclusion criteria, layer it on top of our patient data and conduct some rather interesting sensitivity analyses. Also, not only can we determine the number of our patients who are eligible, but we can determine where those patients are and whether they are near one of our research facilities. So, by undertaking a much deeper exploration of a protocol and better informing that protocol, we set up everyone for success when that study starts.
Additionally, when it comes to study conduct, we can monitor data in near-real time to identify patients who may become eligible for a trial. We can then notify investigators immediately, which makes recruitment much more efficient and targeted.
While we are able to inform protocol design by determining the number of eligible patients and projected enrollment rates, a database-driven feasibility assessment cannot completely tell us which patients, or even which investigators, would be interested in participating in the study. This is likely where traditional site surveys are best suited.
Q: What has changed in recruiting renal patients, in terms of the types of patients over the last 10 years?
A: The trends in recruiting patients who suffer with renal impairment have followed trends in the types of studies, whether drug or device, clinical development phase, and the specific disease conditions being treated. At the moment, for example, there are a number of studies in anemia underway—and, presumably, later phase studies being planned in both the non-dialysis-dependent and dialysis-dependent chronic kidney disease patient populations.
Fortunately, I think we are beginning to see patients becoming more interested and willing to at least consider participating in clinical research. This is partially the result of efforts made by patient advocacy organizations in the nephrology and related disease communities. While this is good to see, we can’t ignore a trend that is troublesome: Protocols have become far more complex than they were 10 years ago. Unless protocols are designed from the start with the patient in mind, we risk placing an undue burden on patients attempting to adhere to those complicated protocols.
Q: You’ve stated that among the most disruptive recruitment strategies will be systems that allow patients to participate in multi-study screenings. How will they evolve, and how do sponsors articulate what’s needed to weigh the economic value of a recruited patient that also will benefit other stakeholders?
A: Targeted patient recruitment is grounded in data and data mining, particularly in the data we are able to access. I am not sure the industry or even medical science is anywhere near to sorting out a multi-study patient participation approach to clinical research. Determining the economic value of a recruited patient is just one of many questions sponsors would need to consider. However, I would propose that an even more interesting question is the economic value of the patient who has completed the study.
In any case, whether we ever see patients participating in more than one study screening at a time may not be decided by sponsors or regulatory agencies, but by patients themselves. It may not be tomorrow or in the immediate future, but as patients become more aware, knowledgeable and empowered, such decisions will likely rest with them. I am actually having this conversation with my phone propped upon a book titled “The Patient Will See You Now,” by Eric Topol. Within that book are some of the concepts, especially concerning information asymmetry, that I am referring to here.
We start by educating patients on clinical research and the opportunities to participate. Armed with that education and awareness, patients will begin to understand just how valuable—and I mean “valuable” in the economic sense—they are to sponsors and to healthcare providers. Once that concept takes hold with patients, how long will it be before patients want to negotiate a better deal than what’s on the table? I have recently asked a few investigators about this. None have seen any evidence yet. But I think that is only because there is a lack of awareness, and perhaps even a lack of interest, in certain patient populations.
This article was reprinted from Volume 19, Issue 40, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »