In August 2015, Christmas arrived early for the Scientific Services Team at Succinct when the anticipated Good Publication Practice 3 (GPP3) guidelines were published in the Annals of Internal Medicine. As medical publication professionals, an important aspect of our role is ensuring that any work we produce complies with relevant guidelines, particularly when authors or pharmaceutical clients are uncertain about their obligations. Given the importance and the impact that updated good publication practice guidelines can have on our day-to-day roles, many of us at Succinct (especially our medical writers) began implementing aspects of the new guidelines while listening to the industry-wide discussion. At the Annual European International Society for Medical Publication Professionals (ISMPP) meeting (19–20 January 2016; London, UK) we were excited to have the opportunity to share our perspectives and thoughts with our peers.
What is new in GPP3?
The core values of the GPP3 guidelines remain unchanged — advocating the clear, timely, high quality and transparent reporting of clinical trial data. However, the new guidelines clarify issues using examples and now include ten principles of good publication practice for company-sponsored medical research, which are designed to aid in the practical application of the guidance. Updates have been made to reflect the revised definition of authorship, as made by the International Committee of Medical Journal Editors (ICMJE), and more practical guidance has been provided to outline recommendations around common authorship issues.
What does this mean for the industry?
The increased breadth of the GPP3 steering committee members is a positive expansion as there is now increased global representation, including professional medical writers, the pharmaceutical industry, medical communication agencies and journal editors/publishers; however, the inclusion of clinical authors should be addressed in future iterations. Efforts in the presentation of the guidelines in order to provide clarity and the addition of examples are also positive steps as they help to exemplify the day-to-day challenges we may encounter in our work.
The subject of author honoraria and reimbursement remains one of the most contentious issues in good publication practice guidelines. The issue of when payment may be appropriate remains much debated and, from our experience to-date, is one of the few GPP3 recommendations which our pharmaceutical clients will supersede with their own internal policies.
What will we do?
We will continue to provide internal and external training workshops in good publication practice to ensure both we and our pharmaceutical clients understand the principles of GPP3 and how they affect the work we do as a medical communications agency and as individuals.
In order to expedite the development of more robust, high-quality and clinically relevant publications in medical research, we must simplify the publication development process and expand best practice education.