Accelerating Phase 4 Clinical Trials a Matter of Improving Enrollment

Aug 1, 2012 by Pharmaceutical Regulatory Affairs

Phase 4 clinical trials not only serve to gather valuable data surrounding drugs’ safety, tolerability and real-time effectiveness, but also to test potential new indications, develop stronger marketing profiles, gain payers’ favor and prove superiority over competitors’ products. While many phase 4 trials are conducted at the requirement of regulatory agencies, many are conducted simply to help boost products’ profiles. Needless to say, these trials can be particularly pertinent to the success, or failure, of a product regardless of the reason.

Phase 4 trials are often planned even before products gain approval. Bottlenecks in these trials can prove detrimental to the strategies so carefully laid out to commercialize products. The first step in preventing trial bottlenecks is knowing what areas prove to be bottlenecks. In a recent study, CEI asked companies to rate eight trial activities based on the opportunity they present to accelerate the overall trial process. The activities included:

Study Design/Concept Development
Protocol Development/Writing
CRO/Vendor Selection
CRO/Vendor Contracting
Site Selection/Enrollment/Contract
Patient Enrollment
Data Cleaning
Statistical Analysis
Of these tasks, patient enrollment ranked as the greatest opportunity for trial acceleration. Ranked closest behind patient enrollment in terms of opportunity for accelerating trials was site selection/enrollment/contracting. Almost universally, interviewed executives revealed that if their companies could improve their performance in these two areas alone, trials would run much more quickly and efficiently – saving time, money and keeping brand strategies on schedule.
Of course the real trick is how to improve patient and site enrollment. Patient enrollment has almost always been, and likely always will be, the most challenging aspect of clinical trials. For phase 4 trials though, many companies do offer successful tidbits for improving patient participation. At one interviewed company, phase 4 leaders discovered that they were not vetting investigators well enough and were likewise not attracting the right investigators to their studies. This was damaging patient enrollment. To attract better investigators, the company began a program offering additional training modules aimed at attracting a specific subset of investigators that would bring more to the table in terms of patients. The team also revamped their vetting process to make sure that interested investigators actually had the means to attract enough patients to justify their participation. The program worked and enrollment has improved.