Since 2015, data suggests pharmaceutical companies are utilizing fewer research sites to conduct their clinical trials, making it challenging for naïve or newer independent sites and investigators to offer their patients this treatment option. How can a site move up the selection list and participate in these trials? It’s as simple as one word: metrics. During my time as the Director of Clinical Research at a large facility, I knew that biopharmaceutical companies used key metrics to decide whether to include a particular site in their program. The good news is that the metrics that sponsors use have largely remained unchanged; the bad news is that it does take some time to be highly ranked by sponsors, and ultimately be selected to participate in their clinical trials. But it can be done!
To overcome these challenges, I have found that it takes a multi-focused effort.
Speed, Quality & Enrollment
The most important metrics I focused on in the beginning revolved around speed, quality, and enrollment. Sponsors want to get their studies up and recruiting in the fastest way possible, and independent sites can leverage certain efficiencies to be considered favorably. Many metrics are well known, such as the time it takes to process a contract or budget, and turn-around time for the confidential disclosure agreements (CDAs), for example. One key data point we focused on involved how long it would take to screen a patient after the site initiation visit (SIV). If a site can screen a patient the following day after an SIV, this sends a clear message to the sponsor that the site is prepared to perform the research, has patients thoroughly pre-screened, and is clearly motivated to perform well on the clinical trial. In order to determine where our facility ranked on these metrics and make decisions to improve the performance of our group, we wanted to determine a baseline to benchmark our data against our peers. After partnering with a group that had a platform to measure certain metrics closely, I was able to clearly see areas for improvement which ultimately led to more studies being awarded.
As clinical research protocols become more and more challenging to execute for the investigative sites, enrolling qualified patients can be complicated by dozens of inclusion and, particularly, exclusion criteria. Even the highest performing sites can struggle with enrollment, while many sites complete the start-up process and never enroll a single patient costing time, money and a missed opportunity for a patient to participate. We had one such protocol that was difficult for us to find patients and devote precious resources to review records and facilitate enrollment activities beyond our capabilities without major investment and risk. Luckily, the biopharmaceutical company offered enrollment assistance, onsite, at no cost to our facility which resulted in our group quickly screening patients into that particular study.
Quality & Compliance
Quality and compliance are paramount for sites during the conduct of a clinical trial. The highest enrollers can be completely discounted if there are dozens of preventable protocol deviations, lapses in GCP compliance, and many other missteps in the process, including financial issues. Independent sites often lack the infrastructure for robust quality and compliance programs such as is typically found at academic medical centers, yet they share many of the same compliance risks. One solution is to establish a process to review the quality of the research on a randomized, peer-reviewed basis. Track the results of each weekly review and utilize that data to adjust workflows or re-train staff on the procedures. Another initiative is to have coordinators and research staff attain certification by one of the stationing bodies, which forces continuing education and drives higher quality.
Finally, after metrics are moving in the right direction, I would establish good relationships with pharmaceutical companies through networking events, media channels, medical science liaisons (MSLs), and anyone in the process who can connect the investigative site with trial opportunities. In the past, I have leveraged MSL relationships to showcase our site and invite the most senior representatives I could to visit the research center and view the enrollment potential, high-quality facility, and motivated team that makes the metrics happen. These relationships can also help the connection between the site and sponsors in reverse, where an industry partner can connect the sponsor directly with the site during the critical site selection process. Those sites with a good relationship with the biopharmaceutical company and solid performance metrics will be selected for the study.
Contact the author: Sean Walsh