Practical Advice for Medical Devices Firms

www.clinipace.com trials demonstrate whether the new treatment is better than the existing. Non-inferiority trials evaluate whether the product is similar to a control that has proven efficacy. In a non-inferiority trial, a known inferiority margin should be selected, and if treatment differences are within that range, then non-inferiority can be established. Selecting a non-inferiority margin should be done in the design stage of the trial. In most cases sample size for a non-inferiority trial will be larger than for a superiority trial. In a non-inferiority trial, the treatment or product under investigation should offer some other advantage such as cost savings or lack of complications relative to the traditional form of treatment. Protocol considerations Clinical trial protocols should contain the following components: achievable objectives, appropriate statistical parameters, a comprehensive introduction with complete bibliography, a satisfactory study population, a complete safety analysis, an appropriate description of the product, a logical study design, and a comprehensive Case Report Form. A study should include a minimum number of subjects to assess the primary objective. In a Phase II trial a large number of patients are generally required. Calculation of sample size in a trial requires knowledge of the power, the significance level, the underlying event rate in the population being investigated, and the size of the treatment effect being evaluated. Use of technology While many clinical trials rely on pen-and-paper for documenting patient data, increasingly electronic data capture is being used for its efficiency. Although use of technology reduces complexity, long-term success depends upon up-front planning and having standardized processes. Software applications have been designed for many aspects of managing clinical trials, including planning, resourcing, operations, data capture, data management, recruitment, and site management. Run a transparent, efficient study During the course of a clinical trial, it is important to have complete visibility in managing operations and accrual of data. Visibility is key for operating the start-up, conduct, and closeout of a trial and managing Page | 5 ©2012 Clinipace Worldwide, Inc. All rights reserved.

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