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Drug Discovery News: Recruitment in practice
LEEDS, U.K.—With a goal of achieving quicker, more efficient and more effective clinical research and trials, Interface Clinical Research—just launched at the Royal Society of London in January—is offering detailed feasibility studies for several major contract research organizations (CROs), forming partnerships with general practitioner (GP) physicians across the United Kingdom and delivering large numbers of suitable patients for Phase 3 and 4 clinical trials.
In just six months, Interface’s new model, driven by sophisticated technology, has reportedly reduced past clinical trial patient dropout rates and rescued several CROs from failed clinical trials.
A division of Interface Clinical Services, with experience working in more than 3,000 primary care practices—representing more than 41 percent of the U.K. population—Interface’s research branch is running hundreds of clinics at GP practices on behalf of both pharma companies and the U.K.’s National Health Service (NHS).
“We are very pleased to be working with the CROs on feasibility studies to demonstrate our impressive patient recruitment capabilities,” states Mike Drakard, CEO of Interface Clinical Research. “Interface manages the whole clinical trial and is responsible to the sponsor for every aspect, from feasibility through the provision of clinical data.”
CROs, in particular, “are turning more to Interface for conducting their clinical trials—mostly for the time saved,” Drakard says. “Interface also takes on CROs who have fallen behind, and then we come in, rescue the trials.”
The fast-paced feasibility work, which Interface has carried out for free, includes studies in cardiology, gout, gastrointestinal disorders and dermatology, he adds.
The great benefit of the Interface model is that many GP practices want to be involved in clinical research, but don’t have the time, Drakard says. With Interface, a GP practice can provide the principal investigator, the premises and oversee the trial process without additional workload. Interface handles the recruitment, randomization, investigators to run the trial, patient retention and responsibility for the data, and has already identified more than 40 GP practices and larger healthcare organizations that are “very keen” to become involved in running clinical trials, he says.
The individual GP model for clinical research has always been inefficient, with 50 percent of GPs finding one patient or less, at a cost of over $50,000 per GP for recruitment and training costs, Drakard says. On average, GPs typically only recruit five patients per trial.
And, as Interface stresses, 86 percent of clinical trials fail to complete on time, with up to 48 percent of research sites in any given trial failing to recruit a single patient.
Interface spokesperson Simon Vane Percy, founder and CEO of Vane Percy & Roberts, tells DDNews that the Interface model would not work in the United States. As he explains, the nature of the multicultural population and the structure of the healthcare system (managed by the government through NHS) in a country like the United Kingdom is what makes the model work and makes it very scalable.
“Interface Clinical Services has worked with over 3,450 practices within the U.K. over the last two years (approximately 30 percent of all practices), and has a national-based clinical team covering the entire U.K.”
From a primary care marketplace perspective, the number of larger practices with better management and more integrated services has increased markedly, with the average size of practices increasing by 19 percent from 2005 to 2015, he says.
“There has also been a very positive trend towards improved GP clinical systems that has seen a reduction in the number of providers and an increase in their functionality that allows for improved data interrogation and QOF (the quality and outcomes framework in place since 2004) [that] has driven better recording of clinical data—thus, improving the quality of the data,” Vane Percy says.
“Nearly every large study has a myriad of different sites coordinated by the pharma directly or the CRO,” he adds. “Interface has more than 80 trained clinical healthcare professionals working across hundreds of GP practices, with hands-on control, particularly since the investigator working with the patients in each GP practice is an Interface professional.”
Access “to millions of patients is a major benefit,” Vane Percy says. “There is a real desire by many doctors to be involved in clinical trials at the forefront of research, but they do not have the time to do it on a daily basis, and certainly not at a scale which requires the supporting infrastructure to carry it through.”
Call centers are “key in coordinating both recruitment and day-to-day interaction with patients involved in trials—and Interface has its own,” he notes, adding that for one major CRO, Interface was able to do a feasibility study and find hundreds of patients within a day.
The cost of bringing a drug to market is currently estimated at $1.5 billion, with costs rising at close to 50 percent over the last decade, Interface reports. The development period of a new drug can take up to 10 years, severely reducing the patent life and revenue potential of any new drug. The longest and most expensive part of this process is the clinical trial phase.
Recently, CenterWatch reported that 58 percent of study volunteers decline consent for a trial, 32 percent fail the screening and 18 percent drop out after enrollment. Running clinical trials in patients’ local GP practices has the potential to dramatically reduce these figures.
The article can be on Drug Discovery News here.