The Site’s Side: What Would Most Help Study Sites?

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The Site’s Side: What Would Most Help Study Sites?

The burden of running a trial today.

Study sites are key to the success of clinical research. After all, they are the link to the study subject, conduct the protocol and provide the data from the trial. Like marathon runners constantly in motion, they are incredibly busy with the numerous tasks involved in conducting trials such as keeping up with regulatory paperwork, ensuring training requirements are met, accounting for study drug, recruiting study subjects, conducting study visits, processing lab samples, entering study data and meeting with CRAs, just to name a few. They are constantly asked to speed up recruitment, and last but not least, are the stakeholder most closely responsible for protecting the safety and welfare of study subjects.

Unfortunately this struggle can take its toll. As Ken Getz reports (Getz, K. (2011) Predicting successful site performance. Applied Clinical Trials, 20 (11) p. 28.)

“Turnover among… investigative sites remains very high. CenterWatch has reported that four out of 10 US Investigators on average, between 2000 and 2009, quit participating in clinical trials each year… Sites note that an onerous compliance burden, difficulties recruiting study volunteers, slow payment cycles and the diminishing attractiveness of study grants have all contributed to the high drop out rate.”

Solutions in the making.

How can the other stakeholders involved in clinical research help study sites? Getz notes that “site support” makes a real difference, including assistance with recruitment and operational aspects of trial conduct. Quintiles has reported that its Prime Sites program, which places relationship managers at select study sites, has been successful. This extra support ensures that attention and resources required to meet the study’s goals per timeline are provided to these sites.

How can we, the clinical research enterprise, BEST help study sites to reach the goals shared by the entire team? What would sites ask for if they had only one wish?

About the Author

Sherry Reuter is President of Sherry Reuter & Associates, LLC, a consulting firm that focuses on the conduct of clinical trials, Site Selection, Study Start Up, Training, and Patient Recruitment and Retention. Sherry may be contacted at sreuter@gwu.edu or 203.775.6031.
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