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Kurt Mussina, MBA, vice president and general manager at Frenova Renal Research
Three Ways to Blast Through the Patient Recruitment Bottleneck
Speed is key in bringing new drugs to patients. Speed in clearing regulatory hurdles, gearing up to product launch, gaining market share—a setback at any point in a drug’s journey deprives patients of novel treatment, inflates costs and truncates patent protection. In short, delays diminish revenue: A 2017 report by Nature Reviews Drug Discovery indicated that each additional month in a typical Phase III trial added a median expense of $671,000 to developmental costs. (1) Eliminating traditional clinical trial bottlenecks can dramatically accelerate the pace of innovation and preclude undesirable inefficiencies.
Patient recruitment is notorious for causing study delays and failures. A 2014 study by the Tufts Center for the Study of Drug Development (Tufts CSDD) concluded that 48 percent of clinical research sites fail to achieve patient enrollment targets, including 11 percent that fail to enroll a single patient (Figure 1). (2)
Fortunately, changing the approach to finding, enrolling and keeping study patients can shorten timelines, improve data quality and heighten a study’s odds for success. Identifying patients by searching comprehensive databases is more efficient than searching databases with limited reach. Designing the study protocol with patients and investigators in mind will ease recruitment, improve protocol adherence and diminish dropout. And finally, enlisting trusted clinical caregivers to ask patients to participate is far more likely to elicit a “yes”.
Access bigger data to find patients more efficiently
The search for study patients is always time-consuming — and hit or miss. The typical procedure is to search through electronic health records — or, slower yet, review individual records — to find patients with relevant diagnoses, select for inclusions and screen out exclusions. These low-yield, shotgun approaches are usually performed one site at a time. When the disease in question is uncommon or combinations of diseases are sought, this tactic is even less productive.
Greater results with less effort can be achieved using a larger, specialized database. Finding an organization focused on the specific patients you need and tapping into that group’s system offers numerous advantages, including higher productivity. Finding a subgroup of patients with concomitant conditions is also much easier.
Moreover, these specialized data sets may provide valuable information unavailable elsewhere. For example, Frenova specializes in renal studies and leverages the data assets of our parent company, Fresenius Medical Care North America, to help inform protocol design and facilitate recruitment for renal-related studies.
Design patient-centric protocols for easier acceptance and adherence
Different kinds of patients — and their caregivers — have different needs. A family member caring for a spouse or parent on in-center hemodialysis is dealing with a challenging schedule. An elderly patient with severe cardiovascular disease and little support may have transportation limitations. These considerations are obvious, but many others are not.
In designing a study protocol, keeping the patient in mind is crucial. Researchers need to ask themselves, “What complexity will my protocol bring to this patient’s life? How will it affect caregivers’ lives? Will this be practical in the typical investigational setting?” Front-line practitioners who are part of the ecosystem of care and who understand the patients’ and clinicians’ day-to-day reality will be able to pinpoint significant, but less-than-obvious, protocol weaknesses and suggest corrections.
Sometimes a seemingly minor protocol condition can make or break a study. For example, dialysis patients have a lot to contend with, especially when they start undergoing in-center hemodialysis. They often must reorganize their lives to receive dialysis treatments that are typically four hours, three times per week, making recruiting and retaining these patients difficult — at first. Once they adjust to the routine, these patients typically become easier to recruit and retain. Even so, details matter. One of our clients required patients to initial every page of the informed consent form. Of all the potential issues, this unnecessary requirement turned out to be the deal breaker: Initialing anything while on dialysis is no easy feat. In this instance, leafing through and initialing pages was the detail that turned patients away.
Consulting with people who know the patient population well enough to catch idiosyncratic problems before study startup saves time and prevents costly protocol amendments. According to the Tufts CSDD, the average cost of implementing a single protocol amendment is approximately $500,000 and adds 61 days to the timeline. (3)
Recruit trusted caregivers to help recruit patients
Patients tend to trust the health care practitioners they know well. Someone approached by a familiar face is more likely to join a study. In cases where the study coordinator is unknown to the patient the ideal way to recruit a participant is to enlist help from a caregiver who already has rapport with that patient. The research coordinator should explain the study and its benefits ahead of time to the caregiver. A patient who is approached by a known caregiver and the coordinator together is far more likely to say “yes” than if approached by a stranger.
Speed enrollment by seeking more extensive information about your patient population
Eliminating bottlenecks in clinical research can save much time and expense. Patient enrollment, which accounts for 35 to 50 percent of a trial’s timeline (4), is the perfect place to start. Qualify patients faster by accessing a larger, specialized and/or more comprehensive database. Avoid costly and time-consuming changes and amendments by finding people intimately familiar with the needs and idiosyncrasies of your patient population. These specialists can help you design protocols that are patient-centric, site-centric and care environment-centric. Consulting experienced partners who can help you focus in on the patient’s position within the research continuum will make your recruitment efforts much more fruitful.
About Frenova Renal Research
Frenova is the only Phase I-IV drug and device clinical development services provider dedicated exclusively to renal research. Backed by Fresenius Medical Care North America (FMCNA), the world’s largest provider of dialysis services with a network of 2,400 dialysis clinics, 250 research sites and more than 450 principal investigators, Frenova is an unparalleled resource for biotech, pharmaceutical and medical device companies worldwide.
Visit www.FrenovaRenalResearch.com for more information.
- Bolten, BM. Fastest drug developers and their practices. The CenterWatch Monthly 2017 Aug 1;24(8). .
- Fenichel M. Site selection a continuing conundrum. The CenterWatch Monthly 2017 Sep;24(9).
- Bolten. Fastest drug developers.