The Value of a Good Medical Writer in Creating a Clinical Study Protocol

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As a pharmaceutical company develops its product, each study should advance the knowledge gained to support the proposed label in the NDA.  Each study protocol needs to define specific study objectives and to clearly describe how the study will be conducted to achieve each objective.  The use of a talented medical writer can add considerable value to this process, as the following case history demonstrates.

An international pharmaceutical company specializing in skin care products was developing a novel prescription skin product.  The clinical team had created a synopsis of a Phase 3 protocol, and had hired an experienced independent contract medical writer to "flesh out the protocol" and prepare a duplicate for a second Phase 3 study.

The writer noted that, although the client had identified 10 adverse events of special interest, no method had been created to capture these events.  Furthermore, there were no provisions for separating skin events occurring at the application site from those occurring elsewhere on the body.  In addition, although the study was to run for a year to capture long-term safety and efficacy, the synopsis lacked several key parameters that needed to be evaluated at the 1-year time point.

After discussions between the writer and the client clinical team, suitable revisions were made, and the protocol was successfully utilized in two Phase 3 studies.  Following completion of these studies and submission of the NDA, the product received rapid approval from FDA.

In this case, the medical writer's knowledge of regulatory affairs and awareness of key FDA guidance documents saved the study sponsor from making an expensive mistake.

Experienced medical writers who think and learn from a wealth of experience can make significant contributions to a sponsor's drug development program and save a sponsor a great deal of money.