Impact of GPP3 Guidelines on Industry-sponsored Research
Clinical trials help doctors to decide the best treatment for their patients. This means that the results must be accurate and reliable. Often commercial organizations such as pharmaceutical and biotechnology companies initiate and sponsor medical research. It is, therefore, important to follow publication ethics and present the work in an unbiased manner.
The Good Publication Practice (GPP) guidelines were introduced in 2003 by the International Society of Medical Publication Professionals (ISMPP) and reinforce high publication standards of peer-reviewed articles and congress presentations.
In 2015, the ISMPP put an independent steering committee together to revise the guidelines and promote publication ethics. This committee included employees of commercial medical organizations, freelance writers, journal editors, and publishers from seven different countries. The updated version—the GPP3 guidelines—contained a new set of instructions for people involved in industry-sponsored research. These instructions promoted ethical, accurate, transparent, and responsible publication practices. The GPP3 guidelines are applicable to all areas of academic publishing.
The GPP3 guidelines outlined ten basic principles to promote good publication standards. These are:
- Report the results and study design of all clinical trials in full
- Follow applicable laws and guidelines during the publication process
- Follow journal guidelines
- Involve all contributing persons in publication planning and development
- Confirm a publication agreement with all contributors before starting research
- Make all data available to all involved persons
- Guarantee full responsibility of all authors
- Ensure authorship accurately reflects the level of contribution
- Disclose the role of all contributors in full
- Disclose all conflicts of interest
These principles ensure that a complete, transparent, reliable, and accurate research presentation takes place, with full responsibility and accountability.
Is it Beneficial to Medical Research?
Unfortunately, research misconduct remains a serious problem as more and more research papers are being retracted each year. In 2011, the journal Nature reported that almost half of all retractions were due to research misconduct. Industry-sponsored researchers should adhere to the GPP3 guidelines when collecting and presenting data from clinical studies. This can avoid misconduct, thereby “cherry-picking” data that supports a desirable hypothesis. Editors of esteemed medical journals are welcoming these efforts to promote publication ethics. Fiona Godlee, Editor-in-Chief of the British Medical Journal has threatened that industry-sponsored research will no longer be published in her journal unless improvements are made in the way clinical trials are performed.
The GPP3 guidelines may also improve the public opinion of medical science. Media has well-publicized research misconduct. The portrayal of medical research as deliberately misleading and fraudulent has left an already skeptical audience even more unwilling to trust in science. The implementation of GPP3 guidelines shows that the publication of medical research is carefully controlled. Furthermore, it demonstrates the commitment of commercial organizations in promoting integrity and transparency of their published work. This could restore public trust in medical research.
Relevance to Authors and Writers
Medical writers help authors to communicate their research findings in a clear and effective way, however, fraudulent ghostwriting has brought this profession under fire. In these cases, pharmaceutical companies paid unacknowledged medical writers to produce tailored research papers. Authorship was then attributed to the respected academics. Understandably, this practice has been widely criticized. The new GPP3 guidelines protect the reputation of medical writers and medical communication companies by instructing them the best practices when working with authors. These new guidelines dictate that authors must direct the manuscript content, and disclose the identity and affiliations of the writer. Furthermore, granting authorship includes:
- Substantial contribution to the concept, design, data acquisition, analysis, or interpretation
- Manuscript writing and revision of intellectual content
- Approval of the final version to be submitted for publication
- Agreement to accountability
More than 90% of individuals working in the medical publication industry already consult the GPP guidelines. Hence we can hope that good publication practices will be followed in all areas of academic publishing, in the near future. To achieve this, the researchers need to endorse and circulate GPP3 guidelines throughout the academic community.
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