Report: Improvements needed for sub-optimal clinical trial design in pancreatic cancer
Monday, December 4, 2017
Progress in pancreatic adenocarcinoma trials is sluggish, which is often attributed to low clinical trial recruitment and substandard design. This results in an inadequate understanding of this notoriously difficult-to-treat disease and poor outcomes for patients, according to GlobalData, a leading data and analytics company.
Clinical trial accrual is poor in pancreatic cancer and there is a need to enroll patients faster to establish the benefit of experimental drugs within a shorter timeframe. In 2011, 4.6% of the total patient population with pancreatic cancer was enrolled in U.S.-based clinical trials. Set against the clinical trial accrual rate in oncology, which constitutes less than 3% of adult US patients, this rate indicates that comparatively more pancreatic cancer patients enroll in a trial than other cancers.
However, the number of patients required to complete accrual in ongoing pancreatic cancer far superseded the number of patients actually enrolling; for instance, a mere 15% of the target enrolment rate was achieved in trials opened in 2011, according to a recent meta-analysis.
Louis Perdios, Healthcare Analyst at GlobalData, comments: “The slow accrual rate is a major cause of trials missing their planned completion dates, and even more unfavorably, trial termination due to insufficient number of patients enrolled. Programs providing the appropriate resources and guidelines are required to support accrual to clinical trials.”
In addition to poor recruitment, pancreatic cancer trials have notoriously poor success rates. Between 1997 and 2015, from a total of 35 unique therapeutic regimens evaluated in 39 phase III pancreatic adenocarcinoma trials, only 11% had favorable outcomes. Notably, 85% of these phase III trials were conducted despite preceding phase II studies not meeting their primary endpoints. As survival is measured in months rather than years, early determination of whether a treatment is succeeding or failing is required. These shortcomings translate into difficulties in conducting large-scale pivotal trials.
Perdios concludes: “Early determinants of response and prognostic measures are still lacking in pancreatic cancer. The downturn in clinical trials can be addressed by embracing technological advances, by tackling inadequate operational procedures, and improving communication between physicians and patients, as well as between cancer research agencies, the pharmaceutical industry and patient advocacy groups.”