Companies that sponsor medical research should pay attention to an updated guideline that was recently released. The document, Good Publication Practice for Communicating Company-Sponsored Medical Research“, more commonly known as GPP3, is the third iteration of the guideline, which goes back to 2003.
The guideline covers all types of documents published in peer-reviewed journals (original research articles, short reports, reviews, letters to the editor) and presentations at scientific congresses and meetings (oral presentations, posters, abstracts).
Here’s what’s new and notable in GPP3:
Studies that Should be Published
“Research results should be submitted for publication in a peer-reviewed journal regardless of whether the findings are positive, negative, or inconclusive or whether the studied intervention is investigational, is licensed, or has been discontinued or withdrawn from the market.”
For studies that have negative findings, inconclusive results, “data of limited scientific or clinical value”, or multiple journal rejections, company sponsors are encouraged to post the study results to public registries or websites.
Timing of Publications
“For licensed products, manuscripts should ideally be submitted within 12 months (or 18 months at the latest) of study completion…For investigational products, manuscripts should be submitted within 12 months (or 18 months at the latest) of product approval or within 18 months of product discontinuation.” [emphasis added]
GPP3 increased the level of detail describing authorship for company-sponsored research, including updating who should be considered an author, the rights and responsibilities of authors, and the contributions of each author to the study.
“Trial enrollment or technical assistance (for example, laboratory assistance, data acquisition, statistical programming, clinical trial management, or editing services) are not themselves criteria for authorship.”
The new guidelines offer suggestions for common issues related to authorship including:
- Number of authors
- Author sequence
- Adding or removing an author
- Death or incapacity of an author
- Change of instutional affiliation
- Company- or sponsor-employed authors
- Professional writers as authors
Authors can be reimbursed for “reasonable” expenses related to publication (for example, travel and accommodation).
GPP3 states that authors should not be paid for their name on the paper or to influence an author’s opinion.
If an author contributes to publication activities (statistical analysis, medical writing) that are not covered by a salaried position at a company, they may be compensated at fair marked value for the services. This category largely includes self-employed writers or consultants.