The Good Publication Practice (GPP) guidelines were first published in Current Medical Research and Opinion in 2003 and focused on the potential for publication bias and the relationship between industry and academic researchers. It was drafted by a relatively small group of consultants. Successive iterations of the GPP guidelines (GPP2 in 2009 and GPP3 in 2015) utilized more rigorous consultation processes with larger groups of stakeholders. GPP2 and GPP3 added additional guidance on:
- The roles of authors, sponsors, and professional medical writers
- The establishment of publication steering committees
- Author payment and reimbursement
- ICMJE authorship criteria
- Ghost writing
- Data sharing
GPP 2022 is the fourth version of the guidelines, also termed as GPP4, and was released last year in August 2022. GPP4 builds on and aligns with GPP3 – not intended to disrupt what has gone before, but offer additional guidance and clarity. To summarize, GPP4 provided additional guidelines on:
- The role of the patient and how we deliver information to patients
- Social media usage
- Journal and congress selection
- Supplemental content and publication extenders
- Real world evidence (RWE) / Health economics and outcomes research (HEOR)
On the first anniversary of its release, we are covering a few GPP topics in a series of focused articles including insights from a representative selection of the GPP authors.
Lisa DeTora, Dikran Toroser, and Laura Dormer, 3 of the authors within the GPP 2022 steering committee represent 3 different and important industries—academia, biopharma and publishing. Enago Life Sciences interviewed them to gain their insights on some of the new topics covered and their implications so far.
In this article, we spoke with Lisa DeTora, Associate Professor, Hofstra University, to gain her perspectives from an academia/higher education point of view.
Interview with Lisa DeTora
Q1. Looking back to when it was published in 2022, have you witnessed instances where these changes have been applied especially in your particular field (pharma, higher education/academics, publishing)?
“GPP 2022 targets company-sponsored research, so I’m answering from that perspective.
I find it really heartening, given the kind of concerns I recall when I initially suggested that we consider diversity and inclusivity as an element of GPP, how much traction it’s had in the field. And just for context, some of the feedback had to do with the logistics of inclusivity in different scientific fields, countries, and therapeutic areas. As an academic who publishes on topics in gender and disability studies, it seemed to me to be a no-brainer, but the potential politics of inclusivity can become really complicated for people trying to work globally in regulated research settings. Even gender designations can differ from country to country.
In terms of uptake, it seems to me that new areas requiring uptake might be health economics and outcomes research (HEOR), nonclinical research, and metanalytical work as opposed to the publication of clinical trial results, which had reached a high state of art by 2019, when the “GPP 4” steering committee (our original name) was recruited.
I also think that the new organization of GPP 2022 fosters the idea of its use in education and training.”
Q2. It’s been nearly 12 months since the release of GPP 2022? In your opinion, where do we stand now in terms of uptake and reception?
“Many groups were already aligned with GPP 3 and could pick up GPP 2022 fairly seamlessly, as was intended. A few blips have occurred. For instance, removing suggested author numbers to align with the updated International Committee of Medical Journal Editors recommendations has created a need for different kinds of conversations. This has been further complicated by the adjustment to ICMJE authorship criterion number 2 that had often been interpreted to exclude from author lists people who did not contribute to manuscripts. Now that ICMJE clarified that they consider critical “review” of the manuscript sufficient for authorship, adjustments may be needed to meet the expectations of academic authors.
I have also fielded some questions about how colleagues should think through and adapt GPP 2022 processes, as suggested, to suit the needs of specific programs, teams, and companies. One example is whether every publication team requires a patient and an HEOR representative or whether each study requires a patient steering committee. Teams will need to develop heuristic approaches—or maybe flow diagrams—for thinking through what kind of input is necessary.”
Q3. GPP 2022 supports enhanced content in publications, including PLS. Is there anything that you feel would help enhance the development and consumption of PLS?
“In company settings, professionals need to operationalize and that complicates the question of how to increase the uptake of PLS in company-sponsored research. PLS are intended for audiences with many different needs, which makes it hard to standardize. One of the strengths of PLS is that they can take many forms for different kinds of outcomes, findings, and documents—or even review several publications. But that kind of creativity can work counter to the day-to-day reality of the publication profession.
PLS also need to address people with different literacy needs—whether scientific, visual, or even basic textual literacy. Journal editors will continue to respond to emerging developments and the literacy practices of many different groups. Plain language and medical communications experts may also have insights in this area.”
Q4. What is the GPP position on the use of generative AI in text and images? Please feel free to share any interesting anecdotes or instances that you have encountered.
“Like every other GPP guideline, GPP 2022 is intended to help authors conform with journal and conference guidelines and avoid specific problems that occur in regulated company-sponsored research settings. AI does not change any fundamental of this work, and AI is not equivalent to chatbots. In fact, AI can generate images or be used in data analysis or even be the topic of a research study.
Problems with AI can include the fact that they generate statistically probable outcomes and therefore outputs need to be checked carefully. Any proprietary and personal information must be protected. Some regulatory writing experts have a lot of experience with AI and may have additional insights into this important area.
The GPP position on AI is that it can be used as permitted by journals and conferences—guidelines by ICMJE and the World Association of Medical Editors are helpful indicators. For instance, both groups indicate that AI is not an eligible author.”
Q5. What is your take on open or transparent peer review, and especially for preprints?
“Preprints are great if you work in an academic setting—like theoretical physics—where there is a culture that supports them. Preprints can be troublesome in some settings, like clinical research, where they can undermine the work of groups like the Cochrane collaboration and raise questions about clinical ethics or make the identity of individual trials confusing for readers. This is one reason why GPP 2022 says that preprints should not be a routine element of publishing clinical research and should be used only to meet public health needs or for specific kinds of scientific exchange.
One danger of open peer review is that authors may later retaliate, so those peer reviews can be less incisive or exacting. Single-blind peer review has other limitations and strengths. Comments like “well, Lisa really knows this area, so A+ from me!” are gratifying, but do not improve the work. But there are other benefits to single-blind review. Given what I publish on, I’ve gotten a couple of peer review comments indicating that academics like me should defer to the opinions of people in industry who assign authorship every day. That comment was not consistent with journal guidelines, which gives the editor an opportunity to ask questions and consider whether they need to provide more guidance. That kind of comment is not possible unless the peer reviewer knows the author’s professional role, and I found that experience to be intellectually valuable.”
Q6. What was the best feedback or question you received after releasing GPP 2022?
“Thank you. That’s the best feedback. The other positive thing I’ve heard is that people felt more included in the process—which was not all that easy to do logistically. It really made it worth all the hours. ISMPP was wonderful about being supportive, but it did take some negotiation to figure out how to invite input that would not create a burden for the reviewers or the steering committee.”
Q7. Any plans for the next version of GPCAP (Good Practice for Conference Abstracts and Presentations)? Would you have any advice for the steering committee for GPCAP?
“We specifically included existing GPCAP guidance into GPP 2022, cited GPCAP extensively and invited its leadership to comment on GPP 2022. The only GPCAP content left out of GPP 2022 was either inconsistent with the updated ICMJE recommendations or not logistically feasible for all scientific areas.
The GPP and GPCAP teams could join forces to issue quick one-page position statements on topics of interest that could then be listed on the GPP page or published in some other accessible place.”
Q8. What do you foresee for the future of GPP? Any thoughts on what would come up as forecasted requirements based on any developments after the release of GPP 2022?
“GPP 2022 was specifically written to be a durable document that could be applied in its present form as other guidelines, like the ICMJE recommendations, change or new technologies, like AI, come to impact publications activities.
We have been discussing the idea of short “position statements” on specific questions—but those statements would not affect GPP per se, but rather would explain how GPP might apply to a specific question, like the recent update to ICMJE authorship criterion two. Just FYI, that change by ICMJE does not change GPP, but it could change SOPs or documentation of authorship contributions.”
Q9. Given the option, and if you had to add or revise any point/s in GPP 2022 at this time point, what might those be and why?
“It felt odd at the time to include this, but a flow diagram or heuristic for following advice that requires adjustment for different situations might be helpful. That does not need to be part of GPP proper, however, and advice could come from a lot of different professional groups.
For instance, PLS ideally can appear for all research. GPP 2022 recommends a PLS for all published research on marketed products and for all clinically relevant published research for investigational products being administered to humans. And least an abstract PLS should be submitted with every clinical trial manuscript that follows the CONSORT guideline (so randomized, controlled trials). GPP 2022 also mentions standalone PLS. Nuanced advice and varied options are difficult to reconcile into an SOP bullet point. And SOPs are necessary for the profession to operate smoothly.
We also removed some explanations when the supplement topped 12,000 words—a few of those would have been helpful given the questions we have received.”
Q10. Is there any question we should have asked and we haven’t?
“It’s important to understand how GPP applies in different scientific contexts. That was the single biggest change—removing the strong clinical context. Laura Dormer and I are working with Tom Drake on a piece for ISPOR that addresses HEOR. I also got to work with Grannum Sant on a couple of pieces in urology journals. And Christine Vanderlinden gave an interview as well. I think that we need to spread the word in different specialties about how GPP can work there.
I also want to shout out to patients and patient engagement. We need more and better progress in that area, and it should be patient led, or at least begin with consulting patients to find out their views.”
We thank Lisa for this enlightening interview and for sharing details that we are sure everyone in medcomms and medical affairs will benefit from.