What are the evolutionary standards in GPP for medical writers?
GPP has grown over time, from defining the criteria for sponsor-based publications to bringing more credibility and openness to non-academic publications. It shows the main features of all three GPP models that have released so far.
GPP, 2003
- Standards for publications arising from Phase II and Phase III clinical trials
- Includes company-sponsored review articles and secondary papers
- Publications from independent investigators studies not included
- More authority to authors in terms of data sharing and knowledge of sponsor's publication policy
- The distinction between authorship, contributorship, and acknowledgements
- Role of Professional medical writers.
GPP3, 2015
- Public posting of clinical protocols and results
- Protocol and results to published for all clinical trials
- Timing of publications
- Publications should follow applicable guidelines: FDA 2007, ICMJE (International Committee of Medical Journal Editors), AMWA (American Medical Writers Association), EMWA (European Medical Writers Association), ISMPP (International Society for Medical Publication Professionals), CONSORT (Consolidated Standards Of Reporting Trials).
- Steps to avoid duplicate publications (ethical guidelines to avoid redundancy) and plagiarism
One of the key salient features of the GPP3 is "Reporting, and publication processes should follow reporting guidelines and applicable laws, such as those of the International Committee of Medical Journal Editors (ICMJE recommendations." Along with recommendations "we recommend," the guideline is now more assertive about what investigators, writers, and companies "should," or sometimes even "must," do. In this way, the guideline, in conjunction with other publication guidelines, will improve the quality of research for future health care.