Michelle Kissner, PharmD, Pfizer Inc, New York, NY; Devy Lee, BSc (Pharm), ISMPP CMPP™, Pfizer Inc, Lake Forest, IL
This article shares information about Pfizer’s experience with the need to develop guidelines and adjust processes, given the impact of the COVID-19 pandemic on medical publication activities.
In December 2019, the SARS-CoV-2 infection and coronavirus disease 2019 (COVID-19) rapidly spread, afflicting tens of millions of people causing a worldwide pandemic. As of March 2021, approximately 125 million cases have been reported globally with over 2.7 million deaths.1 This has had a significant impact on medical publication planning activities. Containment measures resulted in the cancellation and postponement of scientific congresses, a rapid move to virtual formats, pre-prints playing a pivotal role, and open access publishing proving to be more critical than ever.
Authorship – Managing Authorship Challenges During a Pandemic
In March 2020, ISMPP released an Official Guidance2 that advised on managing author non-responsiveness in the wake of the pandemic, resulting in publication delays. This guidance applied only to time-sensitive research when non-responsiveness from authors was affected by COVID-19–related responsibilities. Other reasons for non-responsiveness were not afforded the same exceptions. To remain on the byline, the non-responsive author must have upheld International Committee of Medical Journal Editors (ICMJE) criteria 1 and 2, which include making a substantial intellectual contribution to the research and a material contribution to the publication itself. This ISMPP Guidance was adopted by Pfizer. It was important for critical publications to progress when an author met ICMJE criteria 1 and 2, and as a result of the pandemic was unavailable due to their primary obligation in treating their patients. Based on this ISMPP Guidance, the remaining authors could approach the journal or congress and request keeping the impacted author on the byline. Final decisions were made at the discretion of the journal or congress.3
Congresses – Adjusting to Virtual Presentations
The COVID-19 pandemic propelled Pfizer and authors to adjust from in-person to virtual congresses. Pfizer’s publication teams pivoted to developing online video presentations, which were becoming the new normal. To support the timely presentation of novel research, Pfizer developed new guidance on how to manage virtual congress presentations, which includes requirements for the review of scripts and pre-recordings of audio and video content, when developed with Pfizer support. How to support authors with video recordings and handling Q&As submitted through the online chat functions on the congress portal also needed consideration. In order to produce these new deliverables, budget increases and negotiations with the medical communication agencies were necessary prior to project start. Enhanced content for posters became a primary focus for the publication teams and authors since virtual presentations were becoming the only option. Feedback from authors and congress attendees following the conferences was that enhanced content should become a standard feature as the posters were easier to understand.
In cases where a pre-recorded script was required, external authors were advised content should be conveyed in a factual and objective manner and the importance of fair balance reporting when presenting safety and efficacy information. Authors were advised to disclose that the study was sponsored by Pfizer. Additional compliance steps and guidance for uploading content to the congress portal were incorporated into the best practices guidance to further support the author due to the new and unfamiliar congress templates. In addition to finding the virtual platforms cumbersome to navigate, authors also shared that in-person meetings were preferred because they offered an opportunity to network.
Another challenge that was encountered was obtaining data that met the quality data standards required for publication. This was due to the inability to conduct site data verification. A temporary guidance applicable to only congress publications was developed by Pfizer. This guidance was used in circumstances where research was time-sensitive and delays in obtaining publication-level data had occurred due to outstanding data verification queries. This allowed the use of data for which an extremely limited number of outstanding queries remained. A disclosure was included in all relevant publications for transparency.
Manuscripts – Content Dissemination Focus
For Pfizer COVID-19 publication teams, manuscripts became the main vehicle for data dissemination. One of the biggest impacts was submission and publication timelines for COVID-19 publications were quickly accelerated, sometimes occurring in less than a week. This required internal compliance processes to be expedited. Following submission, journals provided multiple sets of peer-reviewer comments that required rapid turnaround. In some cases, peer-review happened so quickly, authors and publication teams had to take extra care with proofreading and ensuring data accuracy. Author review was essential in ensuring that errors introduced during the journal typesetting process were identified and corrected.
For COVID-19–related publications, identifying peer reviewers was another challenge because of limited expertise in the clinical field. In some cases, manuscripts had to be withdrawn due to the lack of peer reviewers. Furthermore, journals de-prioritized non-COVID-19–related publications, which resulted in the need to withdraw some of these manuscripts.
Additional difficulties arose when journal responses to questions were delayed, with journal author guidelines, pre-prints, and plain language summaries (PLSs) as a few examples. It is widely recognized that PLSs, which make research available in an easy-to-understand format, are a valuable tool for patients, caregivers, non-specialist health care providers (HCPs), and the general public; however, a number of journals do not accept them, which has opened up a dialogue between industry and publishers on how to close the divide.
Pre-prints Value vs. Debate
The need to quickly disseminate medical research related to COVID-19 elevated pre-print servers in the medical research community as they became more widely used. Pfizer adapted to this change and developed guidance for pre-prints since rapid data transparency was paramount in this public health emergency.
The use of pre-print servers to communicate results of COVID-19 research resulted in a debate about the value of pre-prints. The contrast is between the very positive opinions regarding the record speed at which data are shared versus the highly-regarded value of peer-review rigor. Despite this controversy, pre-print publishing has exploded with almost 32,000 pre-prints available publicly related to COVID-19. Currently, MedRxiv, Research Square, and ArXiv are the most commonly used servers.4
The key advantages of pre-print servers are they promote open science, collaboration amongst researchers, and rapid dissemination of information.5 The noted limitations are that pre-prints are not peer-reviewed, no uniform process that ensures quality and validity of the data, and some journals may consider them prior publication.6 While pre-print servers allow for revisions up until the publication is accepted by the journal, a major drawback of posting is the pre-print cannot be removed.6
For those considering posting on a pre-print server, it would be advantageous to check whether the target journal permits pre-prints prior to submission. A key resource to verify is Sherpa Romeo.7 One other aspect for consideration that ensures transparency and upholds integrity between pre-prints and the final version of record would be to link the documents via direct object identifiers (DOI).
Open Access – Value Became Critical
The pandemic has highlighted that peer-reviewed publications remain a critical communication channel. Open access publishing plays a vital role in making all scientific research available to anyone, anywhere in the world. When scientific research is made available by open access, information can spread more rapidly and widely because it lacks a paywall barrier.
Pfizer has been supportive of the open access publishing model and has encouraged its authors to choose open access whenever possible. While some higher-tier subscription-based journals offer bronze open access only, given the need during the pandemic, they have elected to make certain publications freely available. Another barrier that has historically prevented the timely communication of research is embargo periods. Under the pandemic, these have mostly been lifted for COVID-19 publications. Ideally, open access publishing should make any publication available immediately and embargo periods would cease to exist for publications in any disease area.
Evidence demonstrates open access publishing has a far-reaching societal impact through news and social media.8 This is solidified by the high Altmetric score of >18,000 for Pfizer’s Phase 3 COVID-19 vaccine study publication.9,10 Open access publishing has the potential to have a big impact on affecting healthcare outcomes if fairly and readily available to all.
Some useful resources are available to determine a journal’s open access policy. Two resources can be located on the Medical Publishing Insights & Practices (MPIP) website and Sherpa Romeo.7,11 Alternatively, Unpaywall.org is helpful in learning the open access status of an article once it is published.
As a result of the global pandemic, some publication processes were amended/temporarily adjusted, while others continued under the normal course of business.
Learnings identified include the following:
- Adjusted with revised ICMJE criteria to accommodate authors treating patients with COVID-19
- Developed an updated guidance in order to adapt from in-person to virtual congresses
- Expedited manuscripts as the primary source for data dissemination
- Withdrew manuscripts due to lack of peer reviewers
- Use of pre-prints became more prominent
- Highlighted the importance of making publications available through open access
1. COVID-19 Map – Johns Hopkins Coronavirus Resource Center (jhu.edu)
https://coronavirus.jhu.edu/map.html. Accessed March 25, 2021.
2. ISMPP Official Guidance on Authorship of Peer-review Publications in Which Coronavirus Disease Has Impacted Author Responsiveness – March 2020. https://www.ismpp.org/position-statements-and-guidances). Accessed January 12, 2021.
3. International Committee of Medical Journal Editors (ICMJE). Defining the Role of Authors and Contributors. http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html. Accessed January 12, 2021.
4. Dimensions. https://app.dimensions.ai/analytics/publication/source_title/aggregated? Accessed January 11, 2021.
5. MedRxiv, The preprint server for Health Sciences. https://www.medrxiv.org/content/about-medrxiv. Accessed January 24, 2021.
6. Bove‐Fenderson E, Duffy K, Mannstadt M. Broadening Our Horizons: JBMR and JBMR Plus Embrace Preprints. JBMR Plus. 2018;2:59-61. DOI: 10.1002/jbmr.3386
7. Sherpa Romeo. https://v2.sherpa.ac.uk/romeo/about.html. Accessed January 25, 2021.
8. Allen HG, Stanton TR, Di Pietro F, et al. Social media release increases dissemination of original articles in the clinical pain sciences. PLoS One 2013;8:e68914.
9. Dimensions. https://dimensionsplus.altmetric.com/details/95765100. Accessed January 25, 2021.
10. Polack FP, Thomas SJ, Kitchin N et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. NEJM 2020; 383:2603-2615.
11. Medical Publishing Insights Practices. Enhanced Publication Options Navigator. https://www.mpip-initiative.org/transparencymatters/epon.html. Accessed January 25, 2021.