Site Score Card: Expert Tips for Moving Up the Ranks

March 11, 2019 Sean Walsh

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 in 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 mis-steps 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. 

Establish relationships

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 make 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.

 

About the Author

Sean Walsh

Sean Walsh, MBA, ACHE is President, Independent Sites at WCG where he leads the coordination of services to support the independent site community. Sean has enjoyed a long career managing and operating medical facilities from small hospitals to medical centers and private practices. With a passion to improve the lives of patients and families, Sean has focused on developing new care options for future generations through innovation and leadership within the clinical research industry. Prior to joining WCG, Sean was Director of Clinical Research at Raleigh Neurology where he led the execution of more than 300 clinical trials within the largest private neurology practice in the United States leading to several FDA approvals. Sean also worked as a consultant with GuideStar Clinical Research where he advised hospital systems on optimizing their clinical research operation to be more efficient and profitable. Additionally, Sean spent 15 years as a Medical Service Corps Officer for the United States Air Force where he managed the operation of several medical facilities ranging from outpatient clinics to medical centers around the country. Sean is Vice President of the ACRP Research Triangle Park chapter and has maintained membership in the American College of Healthcare Executives. He received is M.B.A. from Webster University and his bachelor’s degree from Boston University.

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