Suggested Reading

Medical Writing: The Art of the Science of Pharmaceutical Development
An editorial by Donna E. Beardsworth, President
Beardsworth Consulting Group, Inc.

You feel the need, the need for speed. You've seen the advertisements that promise developers of pharmaceuticals unbelievable speed in clinical trial design and management. Contract research organizations respond by promising speedy drug development -- enrollment of thousands of patients in a matter of months, lightning fast data review, data entry, and production of clean data sets, and instant availability of tabulations and listings ready for NDA or PLA submission.

Then what? After all, the name of the game is FDA APPROVALS and there is still an application to produce and a regulatory review process to survive.

Pharmaceutical developers and their standard CROs are missing a vital piece in the puzzling game of rapid regulatory approvals, that is, the timely production of high-quality marketing applications. And for that vital component, experienced clinical researchers and medical writers with plenty of FDA experience are required. Medical Writing -- this is where the art of clear, concise writing meets the science of drug development.

According to a recent article in R&D Directions magazine, a recent survey of pharmaceutical developers found that they had received requests from federal regulators to submit more data for nearly 80% of the applications filed. The same developers reported that the data were already included somewhere in the submission about three-quarters of the time. The regulators just couldn't find the data.

Clearly, the missing component is a submission that is not only scientifically accurate and consistent in its support of the issues but one that is also clearly presented, logical and comprehensive, thorough, and easily understood. The application should leave no unanswered questions; it must support logically and consistently the indication for which developers are seeking approval. It should fulfill all regulatory requirements and provide all necessary support documents for the studies it encompasses.

Later in the article it was estimated that 80% of the approval process focuses on the clinical section of the NDA or PLA.

Clinical data should be presented "warts and all". All parties, regulators and pharmaceutical developers, understand that no product is perfect and no development program goes off without a hitch. Deficiencies and problems need to be addressed, they should be discussed thoroughly, they will be uncovered.

The requirement for high-quality submissions does not mean a slowing of the all-important race to regulatory approval. Planning, advance work, a well thought out analysis plan, and consistent report formats help to produce a timely marketing application.

BCGI® provides medical writing services to the pharmaceutical, biotechnology, and medical device industry with focus on the preparation of the clinical components of marketing applications. Our abilities to clearly present clinical data to FDA reviewers has resulted in the timely approvals of many products in our first ten years. In 1996 alone, BCGI® celebrated the approvals of two new products for which we were responsible for the clinical sections of the NDAs -- Forest Laboratories' product MONUROL for treatment of uncomplicated UTI (approved 12/96) and Guilford Pharmaceutical Corporation's GLIADEL Wafer for treatment of malignant glioma (approved 9/96).