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Regulatory and Medical Writing, A Consultant’s Perspective – Part 1 – Introduction

Typing on keyboard

Betty Cory

Author: Betty Cory, President

Regxia Inc.

I have been involved in Regulatory consulting for over 35 years and this has afforded me the opportunity to hone my own medical writing skills and to examine that of many others.  I have learned through trial and error that attention to more than just the words on the page can bring about success in the form of early approvals but also in a broader scope for the promotion of health care products.  I have also learned to appreciate my reader – the government agency reviewers – and to consider their environment and culture when preparing reports.  This, in my mind, is the most important lesson in this field.

In today’s highly competitive pharmaceutical business, new drugs must be approved rapidly by the regulatory authorities and marketed effectively.  As a consequence, drug development must be focused and efficient. Marketing strategy and promotional materials must be in place at an early stage.  This is where a medical writer can be either invaluable or worthless. 

Protocols, Patient information leaflets, clinical study reports, efficacy and safety summaries, clinical expert reports, product monographs, safety updates, investigator’s brochures, advertising copy – all of these require the careful attention and effective presentation of a medical writer. 

This quote from the Journal, Ecology, in their Instructions to Authors, 1964, says it all:

“Write with precision, clarity and economy.  Every sentence should convey the exact truth as simply as possible.”

Medical research demands precision – that we know.  Medical writing must reflect that precision but with clarity.  Glancing at almost any scientific journal will reveal that this ideal is often not attained.  One of the most common criticisms is ‘obscurity’ or ‘elitism’ – albeit most commonly levied by non-scientists.  Unfortunately, the audience for medical writing and regulatory writing specifically, is made up of all genre’s and all must be able to grasp the meaning quickly and, as intended.

The sad fact is that many scientists and medical professionals are not able to express their hypotheses and conclusions clearly and simply – most probably because of their intimacy with the work itself.  Fortunately, much of the confusion can be eliminated if writing is considered a part of the process.  As much effort and consideration should be given to the organization of the paper as was given to the execution of the study and the writer should seek clear and crisp sentences, not cluttered with excess verbiage.

In dollar terms – after all the pharmaceutical business is all about money – millions are spent to perform research and the publication is the distillate of that expensive work, all that will survive and communicate what was learned.  If the content is not clear the research will be lost and the money, wasted.

This article is about precision, clarity and economy.  The ideas are not new but, in my opinion, are valuable both in introduction and in review.  There are no rules to this work as format and style depend on the nature of the piece.  Simplified, there quite often is more than one “correct” way of doing something, the final choice depends upon your intention.  

Before you commit words to paper, you should understand the subject matter that you are trying to communicate.  In other words, don’t begin filling pages with sentences unless you have a general idea where those sentences are headed.  Even after you have that, you should not begin writing until you analyze your writing constraints, those aspects of the writing that you do not control.

In our field, those constraints are clearly ‘audience’ and ‘format’.  Another constraint, however, is mechanics, and that comprises grammar, punctuation and word usage.  Mechanics will trump and override the defined constraints if not given their due respect.

Over the next series of posts these topics will be expanded upon and ideas for improving your medical writing skills discussed.


Interested in having Regxia's regulatory experts assist in preparing your documentation? Learn more about our services here.


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