We all know that as a pharmaceutical company develops its product, each study should advance the knowledge gained to support the proposed product label. Each clinical study report needs to clearly describe the study results, so these results can be easily interpreted and placed into context of the company's overall objectives. 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 oncology was developing a novel product. The clinical team had hired a CRO to create a Phase 3 protocol and associated case report forms and monitor the study. Since the CRO had touted its experience, the CRO was allowed to proceed largely unsupervised by the sponsor. At the completion of the study, the CRO duly supplied the completed case report forms to another vendor, an outside statistical company which then produced the study tables, figures and listings.
The sponsor had hired an experienced independent contract medical writer to create the clinical study report from the tables, listings and figures supplied by the statistical company. The writer immediately noted several key issues with the data. For example, the subject disposition data did not account for all subjects. Furthermore, the number of subjects withdrawn due to adverse events differed between the subject disposition listings and the adverse event listings. The serious adverse event listings were also inconsistent between sources and summary tables. These discrepancies initially appeared substantive enough to compromise the integrity of the entire study.
Because the writer possessed experience in clinical trial operations as well as medical writing, the writer was able to examine the case report forms, analyze and identify the root causes of the discrepancies, then create a plan to reconcile important data fields. The writer was then able to create a clinical study report that (despite some remaining flaws due to poor study design) salvaged the study and its role in the sponsor's drug development plan.
In this case, the medical writer's knowledge of clinical operations as well as regulatory affairs, enabled the writer to advance the clinical study report, and to write the report in a way that made sense of the key issues contained in this very complicated and imperfectly designed study.
Experienced medical writers who combine a knowledge of medical writing with a sound understanding of other areas of pharmaceutical operations can make significant contributions to a sponsor's drug development program and can help the sponsor to salvage an imperfectly designed study.