Why publication guidelines exist
In 2016, writing and publishing a paper in a peer-reviewed journal was the one stage of disclosing a trial's results that no legislation governed, and one view holds that guidelines for publication practice came out of the profession's attempt to win back public trust in the data it reports.
Publication, the one unregulated stage
Most facets of medical writing have always been governed by legislation, and training can be aimed at meeting those requirements. Medical communications, meaning manuscripts for peer-reviewed journals, abstracts, posters and slide presentations for conferences, is one area where it has been assumed that no training is needed. The prevailing belief is that medical writers learn to write these documents during their university education, through expertise passed on by a doctoral or master's supervisor who in turn learned it from their own peers. That belief persists in academia, where despite the need to publish in order to build a curriculum vitae or support a grant proposal, little or no consideration is given to how such publications should be written. The same held in the pharmaceutical industry in the twentieth century, where publication was the final uncontrolled and unregulated stage of a process that had generated the results under strict control from protocol to regulatory submission. The simple view was that scientists would run their experiments and publish the data, driven by academics' need for papers to secure tenure and further grants and by industry's need to promote its products, and the interface between the two was a grey area few understood and most never questioned.
As negative headlines about the pharmaceutical industry became more frequent, public trust dissipated rapidly, which led many stakeholders to demand that the dissemination of data from industry-sponsored clinical trials, and transparency about them, be increased and enforced. The result was a sequential increase in legislated requirements for public reporting of clinical trials. These began with voluntary registration of trials on sites such as ClinicalTrials.gov in the United States and EudraCT in Europe, which industry accepted rapidly once the editors of the major journals made timely registration a condition of accepting a manuscript based on a clinical trial. The requirement to post results on the same sites followed and was also quickly accepted, and in 2016 access for qualified researchers to patient-level data from company-sponsored trials was becoming established. In 2016, writing and publishing papers in peer-reviewed journals remained the last area with no legislation behind it: publication was a voluntary exercise with no legal obligation to publish, driven only by the ethical commitment inherent in the International Conference on Harmonization (ICH) to make all data public and by the knowledge that an unpublished study is a wasted opportunity to demonstrate both full transparency and a product's benefits.
Restoring public trust
One contributor to GPP 2022 holds that much about medical writing in support of publication can be very negative, such as ghostwriting, predatory journals, plagiarism and hidden data, alongside the legitimate service medical writers provide in ensuring the accurate and timely publication of critical scientific data. The same contributor wonders whether people realise what publishing would be like without the support of talented and experienced medical writers. In that contributor's view, the original guidelines came out of the profession's attempt to win back the trust of the general population and to report data consistently, ethically and transparently, a purpose always worth reminding people of.