Retina Today - CLINICAL TRIALS FOR THE RETINA SPECIALIST: Clinical Trial Site Start-Up (November/December 2010)

摘要

In last montha??s column, we instituted the Retina Specialista??s Field Guide to Site Selection, highlighting the importance of choosing the proper site for a productive retina clinical trial and outlining ways for sites to prepare and be selected for participation in an upcoming study. Sites that present themselves as efficient, productive, and experienced in the selection process place themselves in the best position to be picked by the studya??s sponsor. Likewise, understanding what is expected of your site is the first step toward completion of a study. Now that your site has been selected to host a retina study, we will take a look at the clinical trial process from the perspective of an investigative site, targeting the certification process, the site initiation visit, and clinical pearls for conducting a successful study. The study coordinatora??s (SC) role at a site is unique, and his or her importance cannot be overstated. We wanted to truly gain insight into site perspective, so we contacted two study coordinators who have extensive experience in the retina clinical trial field. Mary Ann McCain, RN, serves as Clinical Research Manager (CRM) and SC at Tennessee Retina in Nashville, TN, after spending several years prior working with retina surgeons as a nurse in the OR. Tennessee Retina is one of the statea??s largest and most reputable retinal practices, with a staff of eight board-certified, fellowship-trained ophthalmologists, dedicated to the surgical and medical treatment of diseases associated with the retina, macula, and vitreous. Jenny Daigle is an ophthalmic photographer, has previous retina SC experience, and is currently an Assistant Manager at Ora, Inc., in Andover, MA. As discussed in our first column, the SCa??s duties frequently include correspondence with the managing parties and study subjects, maintaining study logs, and performing various clinical activities and data management.1 Newly selected sites can benefit from McCain and Daiglea??s knowledge of critical site start-up information. VISUAL ACUITY AND READING CENTER CERTIFICATIONSCertification for retina clinical trials is not always an easy process; it is often time-consuming and requires diligence and communication between the SC, site monitor, and the third-party certifying agency. Often sites are trying to become certified prior to the site initiation visit, which leaves SCs pressured to complete a number of labor-intensive certification processes. For purposes of standardization, consistency, and quality of data, clinical trial sites are often required to be certified for visual acuity (ETDRS) and reading center specifications, including fundus photography, fluorescein angiography , and optical coherence tomography (OCT) certifications. The visual acuity certification process can be lengthy because both the lanes and the technicians themselves must be certified. This process may also cause scheduling conflicts with regular patient flow in a busy clinical practice. A third-party certification agency will frequently send a trainer to the site, and although the on-site training session is a critical component of the certification process, valuable clinic space, time, and personnel are made unavailable for up to a full day. Fundus photography and OCT reading center certifications also require a similar significant time and effort commitment from prospective sites. Specific certification requirements may vary between reading centers, and images that must be captured during the certification process (and for the impending study, as is often the case) are often acquired in a different manner from images taken during regular clinical practice. Further, photography certification (color stereo fundus photos and fluorescein angiography) can take several months depending on the skills of the photographer, the reading centera??s specific requirements, and the availability of appropria