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
• Ghostwriting
• Data sharing

GPP 2022 is the fourth version of the guidelines, also termed as GPP4, and was published last year in August 2022 in The Annals of Internal Medicine. GPP4 builds on and aligns with GPP3 – not intended to disrupt what has gone before, but offers 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.

Dikran Toroser, Lisa DeTora, and Laura Dormer, 3 of the authors within the GPP 2022 steering committee represent 3 different and important segments in publications—academia, biopharma industry 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 Dikran Toroser, Senior Director, Publications Group Lead, Merck & Co., Inc., to gain his perspectives from a biopharma industry point of view.

Interview with Dikran:

Q1. Looking back to when GPP4 was published in 2022, have you witnessed instances where these changes have been applied especially in your particular field (biopharma)? What aspect was noteworthy according to you?

“The uptake and implementation of GPP 2022 has been excellent. As you note, there were a number of key additions in GPP 2022. One that I personally think is important is around Diversity Equity & Inclusion (DE&I) that the committee decided to include. We also delved into this a little more in an informative presentation for the ISMPP 2023 annual meeting. Briefly, diversity is garnering significant attention in our profession, both in data generation phases (as in better-designed studies with companies employing well-designed Diversity Plans, as requested by the FDA) as well as the use of Inclusive language in publications that result from the studies.”

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?

“The feedback and reception for GPP 2022 has been tremendously positive. Additionally, the uptake has been excellent, with companies actively incorporating the updates into their publication SOPs, as well as reaching out to discuss details with the committee as well as personally with committee members. In my case, the interactions have been very satisfying.”

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?

“Consistency in applying guidelines and standards, as well as consistency across how PLS are handled by publishers can be important. The percentage of journals asking for PLSs could be improved.  We must also remember that in addition to the principles we covered in GPP 2022, our industry has already done a lot of excellent work around PLS…an example is the recent excellent paper on PLS that was sponsored and endorsed by ISMPP (Lobban et al 2021). I would recommend doing a deep dive into those additional publications that cover both challenges and aspirations, as well as, of course, GPP 2022.”

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.

“Our industry is changing at a rapid rate, and it is so exciting. Generative AI arrived seemingly quickly, almost overnight.  The position of GPP on the use of generative AI would inevitably involve the need to protect ethics. Inevitable questions on authorship attribution, accountability, originality and plagiarism are all being considered, and in detail.  AI is here to stay, and it is more a matter of how we use it ethically, rather than whether we use it.”

Q5. What is your take on open or transparent peer review, and especially for preprints?

“There are pros and cons to the various models of peer review. The element of confidentiality does offer considerable benefits. Open peer review, especially for preprints is a plausible way to carry out peer review, but has its obvious unintended drawbacks associated with the loss of anonymity, including the potential introduction of bias once the identities of authors and reviewers are disclosed.”

Q6. What was the best feedback or question you received after releasing GPP 2022?

“The best feedback I have received has been during the multiple discussions I have had with colleagues that have shared general feedback with me…mostly on how welcome and timely the arrival of GPP 2022 has been for their company and their SOP updates.”

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?

“GPCAP guidance is important and is an essential part of the good practice that GPP 2022 is built on. Our profession is changing at a blistering speed, and there is a need for us to adapt quickly. I feel that the GPCAP steering committee has provided substantial value in tackling significant needs. The GPCAP committee has also produced a sizeable ecosystem of conference-related publication topics and materials that are in the public domain and are valuable for our community and very nicely complement existing guidelines. My recommendation would be to continue the good work!”

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?

“I believe that GPP will continue to synthesize guidance around the principles that are so useful for our profession. The guidance is particularly important around cornerstones such as ethics. Inevitably, there will also need for additional granular  guidance on specific developments that occur very quickly in our profession. I see that applying GPP principles around ethics to these fast-moving concepts (eg, AI) will be essential.”

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?

“I appreciate this question, and it is often useful to do a “retrospective” after a workstream to see what could have been improved. However, I would personally reframe this question to be a little more future-focused: “what would you include in the next iteration of the GPP guidelines?” There are already numerous items that will need to be incorporated and clarified in the next iteration of GPP…I think this is a byproduct of how incredibly quickly our profession is evolving. Lots of work to do for the next iteration of GPP, around AI, peer review, more clarity around social media. There is a long list forming already”

Q10. Is there any question we should have asked and we haven’t?

“One question that interests me personally: Since our community is so heterogenous, how do we have discussions around good publication practice that are inclusive and useful for a diversity of colleagues…ie, make recommendations that work for big pharma, our vendor partners, as well as our academic colleagues. Ensuring sufficient representation of all colleagues in these discussions, from big pharma to all other segments, will be essential for this. Diversity of background for our stakeholders is key to producing relevant guidelines.”