By Amy Young, VP and General Manager, DaVita Clinical Research
Drug development is expensive and complicated. Those facts seem to ring more true each year. According to the Tufts Center for the Study of Drug Development*, a typical phase III protocol now entails an average of 167 procedures, 60 percent more than at the start of the millennium. In addition, “research sponsors implement at least one substantial global amendment for nearly 60 percent of all clinical trial protocols, substantially reducing the number of actual patients screened and enrolled, but leading to significantly longer clinical trial durations and higher costs.” Tufts also reports that modifications to study volunteer demographics, eligibility criteria and safety assessment activity are the most common reasons for amendments, and that many of these are deemed avoidable by the study sponsor.
The drugs and devices in development today are sophisticated, and R&D teams continue to find new ways to apply emerging technology and scientific advancements to clinical trials. Why is it then that we often use the same approaches that we used 15 years ago to evaluate suitable clinical research sites, identify potential patient populations meeting the defined criteria, and evaluate the viability of the study design? Sponsors tend to vet CROs based on feasibility questionnaires that rely on blast faxes to a broad swath of clinical locations. Clinical sites are inundated with paper tasks and quickly fill out these forms, often without the time or capability to search EMRs to validate the data. More recently, large de-identified data sets have been used to evaluate patient population criteria. These sets are often based on claims, which may lack the specificity and detail required to be sensitive to the criteria in laboratory results and other clinical parameters to give a full view of the population.
Integrated health systems with research functions are creating novel ways to overcome these issues by providing the ability to evaluate the study design and entry criteria with large numbers of patients. Because the health care providers have comprehensive information about the patient population, they can guide refinements in specific criteria that may allow for improved enrollment without the need to stumble upon that information during the clinical trial and addressing it in a protocol amendment. What’s even more exciting about working directly with large health systems is the ability to match their providers with the clinical locations that have the patient population needed for the trial. This can be accomplished centrally through database searches and in a HIPAA and HITECH-compliant fashion. This approach can eliminate the need to select CROs based on inefficient faxed questionnaires. It empowers sponsors to consider, as a primary selection criterion, the ability of the CRO to deliver an effective partnership with sites and providers.
It’s time for sponsors to think beyond the traditional approach and look to the provider-based CROs to provide more elegant and effective solutions to clinical trial feasibility and enrollment.
About the Author
Amy Young has been a vital part of DCR (DaVita Clinical Research, Booth #1325) bringing deep experience in the execution of research required to bring new therapies to market. Direct experience in the care of chronically ill patients brings essential knowledge in developing and delivering trials in specialty patient populations. After receiving a B.A. in biology with a minor in chemistry, cum laude, from Augsburg College, she joined DCR holding posts with increasing responsibilities. Young has experience in the areas of strategy, leadership, operations, clinical trial conduct, renal patient populations and clinical services. She holds a CCRC from the Association of Clinical Research Professionals.
* Source: Tufts Center for the Study of Drug Development, csdd.tufts.edu/news/press_releases