New clinical trials model: Move to local GP practices to solve patient drop out crisis
An infographic published by CenterWatch this week shows that 58% of study volunteers decline consent for a trial, 32% fail the screening, and 18% drop out after enrolment. A new model for running clinical trials in patients’ local GP practices has the potential to dramatically reduce these numbers.
The new model, developed by clinical trials company Interface Clinical Research, is based on working with large GP practices across the U.K. to run phase III and IV clinical trials using the existing practice facilities, and recruiting local patients from the practice’s existing patient database. Patients are recruited for clinical trials following a sophisticated database screen, carried out by GCP-trained pharmacists from Interface, which can accurately identify the most suitable patients. This tailored approach to patient recruitment means that far fewer patients will fail the screening for clinical trials.
Interface has also found that fewer patients are likely to decline their consent for a trial being run at their local GP practice, particularly as patients will be seen on time by a dedicated investigator from Interface who is working in collaboration with the GP practice. Dropout rates following enrolment in a trial are also lower, as patients do not have to travel long distances to a dedicated trial site, and will be familiar with the facilities and staff at their local practice. Interface advanced patient retention system has been developed by its sister company Interface Clinical Services, which has run hundreds of patient clinics in GP practices over the past ten years.
This new model offers considerable advantages over traditional ways of recruiting and running trials, using dedicated research centers and individual GPs. The fixed cost of the dedicated research center is becoming a major barrier to offering a competitive service, particularly as they have limited access to large patient databases, and suffer from large numbers of patient dropouts. The individual GP model has always been inefficient; on average, GPs typically only recruit five patients per trial, and often lose patients due to their heavy workload which results in study participants having appointments delayed or cancelled, a fact that obviously contributes to the drop out rate.
Interface has already identified over 40 GP practices and larger healthcare organizations, which would work in a hub and spoke model with adjacent practices, that are keen to become involved in running clinical trials. Interface is conducting large scale feasibility studies for a number of major CROs, using the combined GP databases which together comprise millions of patients.
Interface Clinical Research, a division of Interface Clinical Services, has established a new model to provide pharma companies and CROs with a more efficient service to recruit and run phase III and IV primary care clinical trials. It recruits and runs clinical trials at GP practices across the U.K., providing:
- Feasibility studies
- Recruitment through screening of patient data
- Patient enrolment and randomization
- The running of clinical trials, including sample collection
- The day to day management of patients
- Effective retention strategies
With a team of over 75 GCP trained pharmacists and a dedicated head office support team, Interface Clinical Research is uniquely placed to deliver effective recruitment and running of clinical trials. From database screening through to direct patient support services, Interface apply their un-paralleled experience in GP clinical systems and the primary care environment to deliver successful outcomes in clinical trials and drug development within the U.K. market.