Practical Advice for Medical Devices Firms | Page 4

www.clinipace.com without description as “intercurrent illness” reflect unfavorably on the investigational plan and possibly the device itself. Designing and Conducting Efficient Clinical Trials In developing medical products, planning and execution of clinical trials are extremely important. Poorly designed or executed clinical studies fail to convince payers. Trials should be designed to glean the information necessary for proving the primary and secondary objectives without gathering extraneous material. Economic information necessary for future reimbursement applications should also be obtained. Initial clinical trials include a small number of patients and are designed primarily for safety. Subsequent clinical trials should demonstrate a new clinical benefit or the same benefit at a lower price. The Center for Medicare and Medicaid Services is interested in trials that have comparisons to the best available therapy or to standard of care. Cost data may include such things as reduced hospital admissions or stays, reduced outpatient charges, reduced requirements for medication, or decrease in the amount of required skilled nursing time. Be design intelligent In planning a clinical trial, it is paramount to prioritize objectives and outcomes. For example, is the primary outcome a time to an event or survival? Are the objectives achievable? Consider the number of subjects and sites, and plan to collect only data that will be needed; most data collected for clinical trials is never used, and some data are collected in an inefficient manner. Another important consideration is whether the protocol can be adequately funded. The length of time required for documenting efficacy is usually much shorter than the time required for determining safety. Third parties, such as enrolling physicians, can advise on whether enrolling patients may be prohibitive. Placebo-controlled trials are often performed if there is no existing standard of care. For comparing a new product with an active control, either a superiority trial or non-inferiority trial may be used. Superiority Page | 4 ©2012 Clinipace Worldwide, Inc. All rights reserved.