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KS Manos, PR Orr, NM Bressler, SB Bressler; Training and Certifying Key Clinical Personnel in the Multi-Center, Multi-National Clinical Trials of Verteporfin . Invest. Ophthalmol. Vis. Sci. 2002;43(13):613.
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Purpose: The importance of training and certifying key personnel in multi-center clinical trials has long been established and is essential in multi-national clinical trials because differences in medical practices, procedures, and terminology as well as differences in language and culture could potentially limit the success of the trials. We will describe the training and certification procedures developed for ophthalmologists, photographers, and vision examiners for 3 trials of photodynamic therapy with Verteporfin for the treatment of neovascular age-related macular degeneration. Methods: Clinical center personnel are individually certified. Ophthalmologists formally evaluate case samples to demonstrate their ability to enroll and treat eligible patients. Photographers submit for review at least 8 sets of high quality protocol photographs. Vision examiners complete certification forms and perform a protocol vision examination under observation by a vision monitor. Some vision examiners complete a telephone certification interview. At least one individual in each key position must be certified in order for a center to enroll patients in a study. Results: Approximately 275 individuals, 86 ophthalmologists, 94 photographers, and 95 vision examiners, were certified at more than 33 clinical sites in North America, Europe, and Japan. It takes 1 to 3 days to certify each individual and may take several months from the initiation of the trial for all clinical sites to be certified to enroll patients. Some of the most common problems experienced by ophthalmologists include determining the correct size of the lesions and identifying all lesion components, especially the occult component. Photographers most commonly experience problems with obtaining adequate stereopsis and sharp focus. Vision examiners often have problems refining the cylinder and axis power during refraction and adjusting spherical power to compensate for changing the distance of the visual acuity lane. All problems were sufficiently resolved before certification was granted and patients enrolled in the study. Conclusion: Certification of key personnel in multi-national clinical trials is essential for successful study completion and can help eliminate the potential barriers of medical practice differences, language, and culture. Nevertheless, the cost is substantial. Cost-saving innovations proposed include web-based training and testing of candidates and video documentation of per-protocol examinations.
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