By Deb Borfitz
November 16, 2009 | Attendees of the Fourth Annual Site Solutions Summit, which included more than 150 site stakeholders as well as two dozen sponsors and clinical research organizations, achieved consensus on six site best practices when they met in Clearwater Beach in October. If sites represented at the Summit adhere to the new standards, it could raise the performance bar for sites everywhere, says organizer Christine Pierre, president and CEO of Maryland-based investigative site network RxTrials.
The consensus this year was that sites should require all staff to have Good Clinical Practice training, documented within 60 days of the start of employment and an ongoing compliance program, reports Pierre. Additionally, sites should respond to study monitoring reports in Corrective and Prevention Action (CAPA) format, as they would to a Food & Drug Administration (FDA) 483 inspectional report. Too often, monitoring reports get read and filed by the study coordinator. The investigator may not even see them. A panel of CRO and sponsors at the Summit also indicated that the FDA is putting more focus on investigator oversight and responsibilities and doesn’t expect to see mistakes repeated.
The same panel informally endorsed the idea of having sponsors provide sites with a post-study “report card” as an aid for enhancing future performance, repurposing data from monitoring visits. Asking for that report card was adopted as a site best practice.
Yet another new site best practice is to request monthly payment terms of study sponsors. Under the more common quarterly payment terms, sites already eking by on slimmer profit margins unwittingly assume the risk of debt because it quietly accumulates before payment is due, says Pierre. “It could be four or five months before the site is even aware that payment is overdue or, worse, not coming at all.”
Sponsor reluctance to pay on a monthly basis may be rooted in consistently variable site performance. According to Kenneth Getz, senior research fellow at the Tufts Center for the Study of Drug Development and SSS keynote speaker, 30% of all sites under-enroll and another 20% fail to enroll a single patient. Only 20% of sites enroll 70% of all evaluable patients. Many of those “top performers” participate in the SSS, as evidenced by results of a pre-Summit survey.
The final site best practice established this year is to support education of the general public about clinical research. To that end, SSS attendees voluntarily contributed $5,000 to the Center for Information & Study on Clinical Research Participation (CISCRP) founded by Getz.
Rampant distrust of the research enterprise has seriously weakened public appreciation of study volunteers, says Getz. When CISCRP asked people to name the biggest contributors to mankind, volunteering for a study came in behind blood, organ, and financial donations. CISCRP, perhaps best known for its Medical Hero marketing campaign, is now supported by over 200 organizations within the U.S. It is currently partnering with Pfizer to translate study results into everyday language for clinical trial participants.
The new site best practices join a list of three others established at last year’s Summit: Appoint a primary and backup study coordinator for each study, conduct a post mortem on studies to compare expectations with reality, and refund any unearned money to study sponsors.