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Medical writing was originally an editorial, grammatical, and formatting function that assisted clinicians in developing study protocols, clinical study reports, and manuscripts for publication. Its role expanded into regulatory submissions as regulatory guidelines became more complex, and medical writing assisted in preparing these documents in the correct formats and standards for submission.

Key Highlights

Learn how strategic medical writing differs from standard medical writing in its functions and expectations from the roles of the writers.

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PRA Insights Team
PRA Insights Team

Medical writing was originally an editorial, grammatical, and formatting function that assisted clinicians in developing study protocols, clinical study reports, and manuscripts for publication. Its role expanded into regulatory submissions as regulatory guidelines became more complex, and medical writing assisted in preparing these documents in the correct formats and standards for submission.

In more recent years, the term strategic medical writing has gained popularity as a desirable function. But what is the difference between standard medical writing and strategic medical writing? More importantly, what is the value of it?

Standard medical writing traditionally entails working with collaborators who drive the document development process. The writer is often given direction for the document’s content without any insight into the document’s value for an overall drug development program. Strategic writing is entirely the opposite, where writers are key members of the clinical or regulatory development team, drive the process of document development, and fully understand the nuances of the documents subject matter, with sufficient skills to provide consultancy to any other authors.

Strategic medical writers have a deep understanding of the process of drug development and regulatory strategy, and can pull the clinical team together like the pieces of a puzzle to maximize success of any regulatory submissions. A strategic medical writer brings not only technical skills, but a constellation of other abilities, such as:

  • cross functional team collaboration—bringing marketing, clinical, regulatory, and statistical teams together as needed
  • successful negotiation and leadership techniques—bringing their knowledge of drug development and regulatory strategy to suggest the direction that will lead to a most favorable and rapid outcome
  • proficiency in project management—keeping the team focused and the timeline moving, rather than waiting for a third party to direct the next steps
  • constructing a key storyline—ensuring that data doesn’t just speak for itself, but is explained in an organized and effective manner

The application of this skillset results in a wholly improved document and a streamlined writing process, which ultimately leads to improved outcomes from the submission process. For example, consider the regulations covering Paediatric Investigation Plan (PIP) requirements from the European Medicines Agency (EMA)1,2. A strategic medical writing approach—where the writer can interpret the regulations, knows the properties of the study drug, and understands the company’s needs—might suggest that an innovative Mechanism of Action (MOA)-based PIP waiver application could be filed. Then, the strategic medical writer would have enough understanding to compose a robust justification to articulate that the study drug is intended for conditions that occur only in adult populations, leading to a positive opinion from the European Medicines Agency-Paediatric Committee. With this pediatric waiver, the sponsor saves extensive financial and clinical resources, as well as reduces patient burden by not requiring lengthy and slow enrollment for pediatric trials.

Learn more about PRA’s work with the Paediatric Investigation Plan

The expectation now is that strategic medical writing is the new standard of truly effective medical writing. With the increased volume of pre- and post- marketing authorization regulations, more and more documents are required for submission, which all require understanding and knowledge of both the regulations and the drug development process. With a strategic medical writer at the helm, the submission process runs more smoothly. There are fewer inquiries and questions from regulatory authorities, which leads to more rapid approval rates. This is not only good for business, but good for patients who are awaiting these potentially life-changing therapies.

PRA’s Global Regulatory Affairs team strategically shortens approval timelines and efficiently gets your products to market and beyond. We are committed to keeping our clients abreast of changes in the regulatory landscape to ensure patients are protected and your goals stay on track.

References:

  1. Regulation (EC) no 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004.
  2. Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use.

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