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Jennifer K Trombley; The MacTel Project – Enrolling a Phase 2 Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2041.
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© ARVO (1962-2015); The Authors (2016-present)
Enrolling a clinical trial in a timely manner may be the greatest obstacle when conducting clinical research. The MacTel Project’s Natural History Observation and Registry Study (NHOR) enrolls persons with Macular Telangiectasia Type 2. One of the Registry’s primary objectives is to maintain contact with potential participants for clinical trials. Despite having a more than adequate number of pre-identified potential participants at selected Registry sites, a Phase 2 clinical trial took over a year to enroll and necessitated adding additional sites.A retrospective, descriptive study was undertaken to determine why participants declined to screen. Also, to determine the amount of work/time required to identify a sufficient number of participants to meet enrollment goals.
Nine NHOR study sites were selected to participate in the trial based on the numbers of potentially eligible participants. Two additional sites were later added to achieve enrollment goals.All 11 sites were asked to complete a questionnaire based on their best recollection of the enrollment process. The questionnaire listed possible reasons given by potentially eligible persons for not wanting to participate. The sites reported the number of persons citing each reason. The sites could add other reasons not represented in the questionnaire.The sites were also asked to recall the number of medical/study records they reviewed to identify individuals that were eligible to screen, how many were contacted and how many actually screened.
Nine of eleven sites responded to the survey (81%). The responding sites reported that 311 patient records were reviewed in order to identify 198 persons to contact. Of those, 91 agreed to screen. Assuming a minimum of 15 minutes per record review and time attempting contact, the sites spent over 40 uncompensated hours in prescreening activities.The most common reason given for not participating was vision was stable and treatment was too risky; the same themes were seen across all sites.
Interest in participating in a clinical trial may be influenced by the type of trial (surgical intervention more risky than a medication trial) and perceived severity of the affected persons’ condition. Documentation of recruiting activities may be used to increase compensation from the sponsor. These results may be used to more accurately project the time and work involved in enrolling future similar studies.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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