Medical Writing in Clinical Research
06 Mar 2017
Medical writing can encompass medical communications, scientific writing, scientific communications, and regulatory writing, etc. If we go back to the history of medical writing, we come across Hippocrates, who is known as ‘the father of medicine’. He had written on hemorrhoids, ulcers, fractures, surgery, the sacred disease (one of the first recorded observations of epilepsy in humans) and the book of Aphorisms. He believed that the doctors while treating their patients should always follow a systemic way of observing and recording. This would enable them to understand the natural history of the illness which in-turn would help forecasting the development of the illness in future. Similarly, Andreas Vesalius, a Flemish anatomist, also known as ‘the father of anatomy’, produced drawings of the human body that greatly advanced the study of anatomy.
Need for Medical Writing: Good medical writing represents scientifically generated data in a clear, unbiased and accurate manner to a specific audience, patients or general public, physicians or the regulators. Medical writing is essential for the analysis and interpretation of the data as per the requirement of the organization, and also to provide information and knowledge to various populations, particularly the researchers. Medical writing simplifies a complex idea for a group of mixed population. A well-written clinical study report proves to be of great importance in the production of high quality subsequent documents (eg, CTDs). Inappropriately written or compiled regulatory documents lead to delays in regulatory approval, which may result in the loss of money for the sponsor.
Clinical Research and Medical Writing: Medical Writing plays a major role in clinical trials. Clinical trials are very essential for new drugs to come into the market for various therapeutic areas; similarly Medical Writing plays a vital role in presentation of the research data in a clear, precise and concise fashion.
The following documents are generated by the medical writing department during a clinical trial:
| Research proposals | Investigators′ Brochure |
| Informed Consent Documents | Clinical trial protocols |
| CRF | Clinical study reports |
| SAE narratives | Package Inserts & Patient Information Leaflets |
| Regulatory submission documents – Common Technical Document (CTD) modules such as | |
Qualities of a good Medical Writer: Some common terms associated with quality documents are accurate, compliant, consistent, clear, precise and concise. So, a person who generates a good quality document is a good medical writer. Sound knowledge of the drug development (e.g., pharmacokinetics, biostatistics, nonclinical and clinical research) process and regulatory requirements (e.g., regulations, guidance documents) is very much essential for a good medical writer. Also, the writer should have the ability: to understand the purpose and requirements of the task, to think and write at a level appropriate to the target audience, for logical organization of thoughts and ideas, and should be able to work across teams (often remotely) as well as independently. Good communication & coordination with various teams/stakeholders involved is a must, with excellent time management skills to meet deadlines.
Future of Medical Writing: Medical writing requires an understanding in medical science and good writing skills; we can define medical writing as a science and an art. Adequate knowledge of specific regulatory requirements/guidelines for different types of documents is required. In the current scenario, wherein the bio-pharma industry is looking to cut costs, medical writers are very much in demand. Hence graduates and post-graduates in life sciences and pharmacy who have the right writing skills and talent can consider medical writing as a full-time profession.