Medical Writer: an essential player for Science
With this contribution, Maxer inaugurates a short series of articles on a subject little known by the Italian biomedical publications: the medical writing. Elisa Sala, author of these articles and Maxer collaborator, highlights the added value of this discipline, more and more relevant for the strong bias to transparency that the biomedical enterprise is taking, and underlines the decisive role of the medical writer in the communication of scientific data.
The medical writer is a professional with valuable expertise on scientific and medical writing who can produce a wide range of regulatory and informative documents, He contributes to Science advance describing and accurately reporting the work of others and he’s a scientist, even if he does not directly work at the bench. He is the first reviewer of protocols and manuscripts that is asked to write.
The medical writer has a pivotal role both in pharmaceutical companies and in academia. However, his role is different: in pharma regulatory documents are required for drug approval while in academia publishing means surviving in the international panorama.
During drug development, the medical writer is mainly involved in clinical phases when it is important to write a number of regulatory documents directed to medical doctors and clinical investigators, to patients who undergo the study, to ethical committee and regulatory authorities who guarantee the compliance to international laws. All users must receive a correct, clear, and accurate message. The skills to produce these featured documents are not always internally present or available at the clinical research organizations (CRO) that manage and perform a clinical study. Medical writing agencies and freelance medical writers can fill this gap and offer professional services to produce all required contents. It’s not by chance that in the last years, writing activity became the fourth service more frequently outsourced by pharmaceutical companies. Medical writer’s activity will become more relevant for pharma companies in the next future when it will be mandatory to publish clinical trials results, as stated in the current EMA (European Medicines Agency) regulations.
Publishing research results is an ethical and professional must for all medical and biomedical researchers who receive public and private funding. A medical writer may contribute to manuscripts improving communication clarity and ensuring compliance to international guidelines. The manuscript must highlight the novelty of the study and answer to the scientific question. Manuscript length and structure are limited and fixed by medical journals and should be strictly observed. Medical writer and scientist should collaborate to properly communicate the scientific data; writing skills and technical and scientific competences mutually enhance, thus guaranteeing higher chances of success in the peer review process.
The most important universities and research centers have already employed medical writers who contribute to manuscript writing and submission to journals.
The medical writer are acquiring an extraordinary relevance in pharma and academic world and will guarantee cultural advance and transparency in clinical trials in the next years.
- Key factors a pharmaceutical company should consider while outsourcing medical writing services. Nagdev KJ, Agrawal AR Medical Writing 2014 (3)23:223-227.
- Working with authors to develop high-quality, ethical clinical manuscripts: guidance for the professional medical writer. Hindle A, Tobin SC, Robens J, McGowan D Medical Writing 2014 (3) 23: 228-235.
- European Medicines Agency (EMA) policy on publication of clinical data for medicinal products for human use.