Practical Advice for Medical Devices Firms | Page 4
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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
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