Critical points of medical writing

An important part of clinical studies is often associated to write report, analyze data and do statistics. Commercial software are now available to facilitate data collection and management and the collaboration between institutions, but one difficult work still be the elaboration of the results and the creation of final report to be presented to approval committees. Thus, medical writing department assumes crucial role in a pharmaceutical company. This department must be organized in order to efficiently accomplish the production of promotional materials, documentation for marketing new products and manuscript for publication. Medical writing follows specific guidelines to guarantee scientific correctness and ethical standards. Indeed, results reported in papers, reviews and brochures must be rigorous, transparent and consistent; the writing must be comprehensible, accurate, concise and logically organized, all the assertions must be justified and proper terminology facilitates the proficiency. Medical and nursing professionals often don’t have time or inclination to write their papers, as well as in pharmaceutical companies results from unsuccessful clinical studies are not published again because of lack of time.

It’s astonishing that a large percentage of works presented in national meetings doesn’t proceed to publication in peer review journal. In this way the advances of science are avoided. Fortunately, professional medical writers can supply the important service to write papers and reviews and make these data available to scientific community. Medical writer are often ghost- writer and their name doesn’t appear between authors in the final publication, even if now a task force of European medical writer association (EMWA) tries to solve this problem. For transparency, indeed, the reader should always know about the presence of a ghost-writer and also the name “ghost-writer” itself is misleading; EMWA task force suggests the use of a more neutral term. Anyway, medical writing still stimulating and interesting work, because allows to enter in direct contact with clinical researchers and know results of studies before the publication itself. Not only physicians and scientists must be responsible of data truth, but also medical writer must learn about ethical practice: in this way, papers are really scientifically correct and scientific literature continues to have a significance. Furthermore, founding and grant achievement are often associated to the number and quality of publication of the principal investigator, so writing numerous papers represents an opportunity also to obtain financial advantages, rather than scientific. Publishing results allows to receive feedback about your study and useful suggestion for future perspectives and, in some cases, to create a network of common interest with other groups that work at the same topic. In conclusion, medical writing is one new aspect of scientific and pharmaceutical life that guarantees success of studies, but also could be considered a new profession with specific rules, aims and challenges.

Challenging on data management

Data management is a crucial aspect of scientific work, not only to correctly collect and retrieve information, but also to constantly have a complete vision of the work. In quality control system, data are classified by a code, defined by scientists and common for all laboratory members. For instance, files can be named with date, operator, project and kind of experiment: in this way it’s possible to identify one file without loosing time to check all folders and open every document.

Otherwise, it’s possible to use special software that is commercially available to manage your data. In lab research different kind of data can be generated: firstly raw data, such as numbers, pictures or texts (for example patient interview in clinical studies). Raw data have to be conserved, retrievable and in some cases protected by password, especially in clinical studies when sensible information about patient’s health are collected. These data can derive from several instruments that work with their specific program: they have to be converted in a unique format in order to be useful for elaboration. Raw data are usually resumed in graphs or tables that can immediately and communicate the result from complex experiments. At this point, it’s crucial to choose the best way to communicate results and valorize your work. Indeed, few graphs and table in scientific article have to present a long work made by several scientists in some cases. A correct data management system is useful during article writing to retrieve all important information and it’s cost- effective because avoid to loose time in searching raw or elaborated data or in repeating experiments those data are missing.

Not only in laboratory research, but also in clinical trial is important to correctly manage data for different reasons: firstly in clinical trials data often derive from patients and are subjected to privacy law, secondarily a really large amount of data are usually produced, especially during latest phases of trial when thousand patients are enrolled, lastly clinical trials are expensive and correctly managing data decreases costs. Data management software is feature-rich and includes planning, preparation and performance rather than raw data collector. Moreover, scientist contact information, deadlines, milestones and progress report have to be available to allow a complete overview of the project. The software is usually used in different centers around the world because clinical trials involve several institutions and must be user-friendly and verified from external intrusion.

In conclusion, data management is a challenging aspect of modern science for many reasons: data generated from research or clinical studies are a huge amount and often derive from different institutions that collaborate: this means that coordination between centres in data collection is essential; moreover, data are conserved and protected in respect of quality control standard and privacy law, respectively. Modern and efficient software is available now, and in next future it’s necessary to further customize IT products in order to make data management easier and less expensive.