PQRI Guidance on Document Publication

PQRI recognizes the importance of positioning PQRI as an authority on scientific research, and views peer-reviewed publications as one major avenue through which such branding may be accomplished. As such, we encourage all PQRI Committees and Working Groups to promote the value of PQRI and its research and findings to as broad a scientific audience as possible.

This is in line with the current Mission and Vision of PQRI which states: PQRI advances science-based regulation, within the framework of risk management principles, by:

• collecting, analyzing and interpreting data
• conducting research and testing
• communicating results of its work to the public

In response to questions regarding the PQRI policy on document publication, the PQRI Steering Committee has drafted the following document.

PQRI documents generated by Working Groups will be of several types. Examples are:

• Formal recommendations to FDA, or other regulatory authority, with accompanying justification
• Papers containing scientific information derived from original research, data mining, industry surveys or consensus of knowledgeable experts
• "Stimuli" articles intended to elicit broader input from external parties
• Workshop reports
• Technical progress reports
• General non-technical news articles promoting PQRI research and ongoing work

In order to maintain transparency and visibility of PQRI activities, all Working Group final output will be disseminated publicly once the documents have been approved by the Technical Committee and Member Organizations, and formally transmitted to FDA or other regulatory body, as appropriate. At a minimum, this will include posting on the PQRI website. Publication of final recommendations in a scientific journal will occur where appropriate in a broad-based scientific journal in concert with the PQRI Mission.

The PQRI publication policy should be considered in the context of PQRI’s other procedures and PQRI’s general purpose. With the exception of promotional news articles, each PQRI publication undergoes a thorough internal peer-review process consisting of the following steps:

1. a draft is typically written by a small subgroup of experts in the field;
2. it then is reviewed and commented on by the full Working Group, which includes a broader range of scientific and regulatory experts on the subject. The committee strongly recommends that this process take no longer than one month to ensure timely dissemination of the research;
3. after the Working Group has prepared the manuscript, it is reviewed by the Technical Committee, which includes representatives of the PQRI member organizations;
   • The Technical Committee is responsible for ensuring that the document is reviewed by all PQRI member organizations (currently, AAPS, BIO, CDER, CHPA, GPhA, IPAC-RS, IPEC, ISPE, PDA, PhRMA and USP) for final comments.
   • To avoid further delays, once a majority vote is achieved, the following caveat will be disseminated along with the final product: This is the view of the majority of PQRI and does not necessarily represent the opinion of each of the individual member organizations.

At each stage, the comments are taken into account and the draft is revised to incorporate all appropriate feedback. Overall, PQRI documents are products of a collaborative process among many experts, often incorporate public input obtained through workshops and member organizations review, and represent the approved position of the Steering Committee.

Guiding principles on selecting publication outlets:

1. PQRI requests that priority be given to PQRI member organization publications; however, we also support other scientific journals that will yield the broadest exposure to support the goals and objectives of the Institute.
2. The Working Group should provide the Visability Committee (VC) with the names of the three most appropriate publications. The publication outlet should be appropriate to the intended audience for the particular content of the document, and have recognized scientific credibility and prestige within the scientific community. VC will then work with these identified outlets to obtain rights to further disseminate the published document as PQRI deems appropriate, including on the PQRI website and through various member communications (e.g. newsletters, listservs, etc.) This will generally require a waiver of standard author-publisher reproduction agreements. If rejected by the initial publisher, the paper will be submitted to the second priority publication, and so on.

PQRI recognizes the importance of peer review as a cornerstone of academic and, in some cases, industrial publishing.

The editor of any scientific journal is primarily concerned with ensuring that a thorough and consistent review is implemented for all submissions. Responsible not only for the reputation of their publication, but also for the accuracy and relevance of information being disseminated to the scientific community, publishers have strict guidelines about their editing procedures, which they are unlikely – and in many cases, unwilling - to renounce.

In the past, PQRI policy has required that publishers waive the peer review process given the Institute’s detailed internal review. However, we have found that this has unduly hampered the publication process, and, therefore, visibility of the Institute. We therefore support the individual peer review policies of individual publishers, and will stress our desire to view such recommendations prior to publication.

The Working Group chairs will be responsible for reconciling any peer review comments with the editor and may work with the Technical Committee Chair or Working Group members as appropriate.

PQRI appreciates the efforts of the various Working Groups and Technical Committees. We look forward to serving as your partner in the publication process, to increase visibility and scientific credibility of PQRI, and to facilitate the Institute’s goals and objectives. Please contact VC Committee Chair Mary Oates at mary.oates@pfizer.com with submissions or any questions.