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Statisticians

Clinical Trial Design

by Scott Martin

Clinical trial design and implementation can be very difficult. Since these trials often deal with medication, surgeries, and other treatment options, there are many ethical considerations that need to incorporate into the research design. Reviewing and approving these projects is often time consuming and bureaucratic because some of these trials put participants lives on the line.

Complexities of Clinical Trial Design

In some cases, a design that would provide the most statistically sound results is not ethical. Because of these ethical concerns, most grant applications have to be approved by a "human subjects" review committee before they are even judged on their merit. This means some trial must modify their design in order to receive approval.

With the complexities of clinical trial design, a statistical consultant is useful. First, it is important that a power analysis is conducted in order to verify that statistically valid results could be generated. Furthermore, if the clinical trial design is modified to comply with regulations, it is essential to determine whether these changes will affect your analysis plan.

When developing a clinical trial design, it is important to conduct a literature review of previous works related to the trial. Then you must check and make sure that the research plan will answer your research question. If it does not, then you need to go back with your statistical consultant and redesign your methodology.

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