GPP 2022 Frequently Asked Questions

The aim of the GPP 2022 Steering Committee is to provide answers to questions on a rolling basis. Question? Email [email protected].

Why did you change the GPP terminology?

The original intention of GPP was to align with other sorts of good practice, such as good clinical practice (GCP).  These do not carry version numbers.  Feedback at the 2022 Annual Meeting of ISMPP aligned with this idea.

We envision “GPP 2022” as an interim or transitional usage. It is our hope that the profession will use GPP (2022) at the first instance of use and refer to the current version of GPP thereafter.  

This should benefit future users by limiting needed adjustments to SOPs and policies.

Can we compensate patient participants and patient advocates for time spent in publications activities?

Yes. Compensation may be offered at a reasonable rate for participation in publications activities, including, but not limited to, Steering Committee membership, reviewing manuscripts and/or plain language summaries, and travel to meetings. Appendix Section G indicates that this is not a disqualification from authorship.

Is compensation for time spent on publications an automatic disqualification from authorship?  Could that constitute “payment for authorship?”

No. As explained by GPP3 authors, it is not unethical to compensate (at a reasonable rate) those who spend time on publications activities even if those activities come to qualify them as authors of a paper. Such activities might include, but are not limited to, contributions to data analysis or serving on a publication steering committee.  

The phrase “payment for authorship” does not appear in GPP 2022, and this concept should probably be redefined as “payment for guest authorship”—that is, when an expert is compensated at a highly generous rate to list their name on a paper of which they are not a qualified author.

We understand that a concern around the issue of paying investigators for authorship activities has always existed, especially for those investigators who are also prescribers, because of the potential perception that company sponsors might trade authorship for influence over prescribing habits. (See Supplement Table 3). We also recognize that regulatory guidelines and reporting requirements regarding payments to prescribers may differ based on various factors—GPP 2022 specifies that such requirements must be met. Companies must assess these requirements and related risks when developing their policies around payments to healthcare providers, both generally and for specific cases. Companies should assess such risks when executing contracts with clinical trial investigators, whether for work directly on the clinical trial, or for other services, such as authoring papers, reviewing documentation, or serving on a publication steering committee.

Will plain language summaries (PLSs) always dramatically increase publications costs?

No. As noted in Supplement Section A, a PLS may appear in a variety of formats from short-form, text-based abstracts to longer form, video, infographics, or other types of graphical summaries. Deciding which type or format of PLS to use should include factors such as budget and journal options. A brief plain language abstract is sufficient for many, if not most, publications and should not generate excessive additional costs. 

Why is there not a PLS for GPP 2022?

The abstract and GPP 2022 itself were written using plain language suitable for their intended audience of publication participants, students, and journal editors. We also included standalone figures and tables for key elements of GPP that could be extracted and shared with authors, contributors, reviewers, and other professionals.

Why do there appear to be conflicting PLS recommendations?

Appendix Section A of GPP 2022 recommends a PLS for each publication of clinical data that follows the CONSORT guidance, in keeping with the recent ISMPP publication on PLSs.  This recommendation is intended to have more force than the suggestion on Supplement Section H that ideally each journal article should have a PLS, keeping in mind that a PLS can take many forms and that a standalone PLS can be prepared to explain multiple publications and studies.

How can we better manage ICMJE authorship criterion #2?

The ICMJE authorship criteria require authors to draft or critically revise the text of publications. Therefore, in keeping with the AMWA/EMWA/ISMPP joint statement on working with medical writers, we encourage teams to solicit introduction and discussion points from authors prior to creating an outline or first draft of a publication. Academic authors should be specifically invited to share their views.

Some teams may consider the requirement for critical revision to be met if an author explains (either in writing or during a meeting) why a text prepared by a professional medical writer accurately reflects views previously expressed by the author during data review meetings.

How many steering committees should be formed?

As explained in Supplement Section D, the function of a publication steering committee is to consider the best way to publish data that will appear across multiple publications in situations where outside advice will benefit the authors and other contributors of those publications.  Therefore, a publication steering committee should be formed for every study or group of studies for which a need of such outside advice is anticipated.  A steering committee may not be needed for each study or program, even if multiple publications are planned. In those cases, the publication working group can perform the functions that would have been performed by the steering committee.

However, it may be prudent to form a publication steering committee for every major product or program (or logical groupings of products and programs) in case questions arise.

GPP 2022 Supplement Section D also mentions patient steering committees, which may be formed in situations where it is anticipated that advice might be needed from such a body.

How should RWE/HEOR/PRO colleagues be included in publication working groups or steering committees?

As explained in Supplement Sections D and F, the purpose of each publication working group or steering committee is to oversee a specific publication or group of publications.  Therefore, appropriate RWE, HEOR, and/or PRO colleagues should be included in all publication working groups and steering committees that oversee the publication of data that would benefit from such expertise.  In cases where RWE, HEOR, and/or PRO expertise is not needed, then it is not necessary to name representatives to a steering committee or publication working group.