Novel Approach for Higher Follow-up in Clinical Trials
Melissa A. Mueller, M.D.1, Larry S. Nichter, M.D.1, Robert S. Hamas, M.D.2.
1University of California, Irvine, Orange, CA, USA, 2Private practice, Dallas, TX, USA.
PURPOSE: FDA approval of breast implants requires pre-market approval (PMA) applications with clinical studies demonstrating safety and effectiveness. High follow-up rates in cosmetic patients are difficult to achieve, but imperative to produce complete clinical data. The PMA study for Ideal Implant, an innovative saline-filled implant pending FDA approval, incorporated a novel incentive strategy to achieve higher follow-up rates than in previous breast implant trials.
METHODS: At enrollment, \,500 was deposited into an independent, irrevocable trust for each of the 502 subjects and invested in a diversified portfolio. Subjects are not paid for the required follow-up visits: 2 months, 6 months, 1 year and annually through 10 years. If a visit is missed, the subject is exited from the study, but her share of the funds stay in the trust. At the conclusion of the 10-year study, the trust will be divided among those subjects who completed all their required follow-up visits (currently, each subject’s share is \,533). For the primary augmentation cohort, FDA published follow-up rates from PMA studies were compared for all currently available breast implants.
RESULTS: Two, three, and four-year follow-up rates were much higher for Ideal Implant (97.9%, 96.9%, 96.1%) than any other, e.g., Mentor MemoryShape (93.9%, 84.6%, 77.6%) and Allergan 410 (89.7%, 87.0%, 84.7%). High follow-up rates are anticipated as the Ideal Implant trial continues.
CONCLUSION: This trial proved the utility of a novel approach to maximize follow-up in cosmetic surgery patients, which benefits any prospective research by providing more complete data.
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