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Clinical Trials

Publication of Clinical Trials and the Pandemic

The COVID-19 pandemic made many aspects of our lives more stressful. In the medical field, academic centers shut down, private practices decreased patient volume, and clinical trials (that were not related to COVID-19) had setbacks.

Beginning in March 2020, many pharmaceutical companies announced disruptions to planned and on-going clinical trials.1,2 Enrollment for many trials was put on hold, while other trials were ultimately terminated. Fortunately, as lockdown restrictions eased during the summer of 2020, trials started to resume but re-openings were slow (see Figure 1).1
Graph showing lockdown restrictions easing during the summer of 2020, trials started to resume but re-openings were slow

Despite increased safety precautions in clinics (eg, increased use of personal protective equipment and screening for COVID-19 symptoms), patient enrollment in clinical trials remained low. Clinical trial investigators we work with noted that patients were unwilling to appear for multiple visits, preferring to space out visits and adopt telehealth appointments. With the approval of multiple COVID-19 vaccines in the US and Europe, more people may be willing to enroll in clinical trials once vaccines are readily available and dispensed.

How do we continue publishing new findings if clinical trials have been derailed?

The pandemic’s effect on clinical investigations will be followed by a lull in non-COVID associated publications. Randomized clinical trials are necessary for bringing treatments to market, but real-world evidence studies can be completed rapidly and still offer valuable insights about treatments to the community at large. For clients who have suffered setbacks with clinical trials, publishing real-world evidence studies and post-hoc analyses of completed studies may be a great way to communicate new information about a pharmaceutical product.

The COVID-19 pandemic has affected clinical research, which will ultimately impact publications.

The COVID-19 pandemic has stalled the progress of many clinical trials, which will slow down publications that are based on those trials. In addition, the manuscript submission process may have also slowed down. Many medical journals have prioritized manuscripts related to the pandemic, and many of these journals have instituted a series of changes to facilitate the release of fast, open-access COVID-19 related publications. Consequently, a backlog of manuscripts not related to COVID-19 may have been “triaged.”

Publication planners can assist the process by reevaluating target journals.

Publication planners can conduct additional research to confirm if the original target journal for a manuscript is still the best option. It will be important to inquire if the findings of the manuscript will be given the same consideration and if the timeline for publishing has changed. Communication between journal editors and publication planners will become more valuable during these times. By generating a pre-submission inquiry to a journal editor, publication planners can verify if a manuscript will generate interest and break through the COVID-19 fog. There are many journal editors, who would be happy to discuss potential submissions, and they can let you know how long the review period will be. The International Society for Medical Publication Professionals (ISMPP) offers further instructions for writing a pre-submission inquiry.3

The COVID-19 pandemic may have caused disruptions to the manuscript submission process.

As authors joggle additional personal and professional responsibilities, they may not be as responsive as usual. Fortunately for publication planners, ISMPP has issued guidance to time sensitive research in the event that COVID-19 has affected an author’s ability to participate in the manuscript submission process.4

Image of a person holding a publication

As a medical communication agency, we understand that thought leaders are involved in many aspects of medical communications and clinical development. Ensuring their availability and streamlining their involvement as an author will be crucial. The publication review and approval process may also need to be reevaluated during the pandemic. While publication planning software may be available to some to assist with this task, for those to whom it is not accessible, keeping track of any changes to the publication process can done with spreadsheets and checklists (See this article from The MAP newsletter for more helpful tips about publication planning).5

Interest in COVID-19 related research has brought attention to an alternative means of data dissemination.

The typical time to publish an article depends on the journal (BMJ reaches a decision within 8-10 weeks, manuscripts published by Elsevier will be reviewed within 80 days, and JAMA typically makes decisions within 31 days).6-8 Since the peer-review process is typically a lengthy one, some people have turned to alternative means of disseminating new data, particularly for COVID-19. In addition to peer-reviewed articles, many preprints related to COVID-19 have been released during the lock down (see Figure 2).9,10

Graph showing that in addition to peer-reviewed articles, many preprints related to COVID-19 have been released during the lockdown

Preprints are manuscripts that are open access and have not been peer reviewed. medRxiv and bioRxiv are two popular databases where researchers can upload preprint manuscripts. These types of publications are a rapid means of data dissemination that are not considered “duplicate publication.” However, ICMJE guidelines state that authors should declare preprints during subsequent manuscript submission to a peer-review process. While preprints are citable, they are not indexed in MEDLINE nor deposited in PubMed Central, and these non-peer–reviewed articles should be examined and interpreted with a high level of scrutiny.

Since preprints have been increasing in popularity, prominent organizations and institutions such as MIT Press-UC Berkeley and Johns Hopkins University have begun to vet preprints and offer reviews of the findings.11-13 Although preprints are a less rigorous alternative to the traditional peer-review process, their increasing use is generating an impact that warrants attention. On one side, the sooner novel information spreads, the sooner that information can be used in the clinical setting. Conversely, making conclusions from dubious research or hastily-released results can have detrimental consequences.

What about congress publications?

Of course, publication planning involves congress publications just as much as journal publications. As congresses switched to a virtual format this past year, exciting changes were applied to congress publications as well as congress activities. For more information about how virtual congresses have impacted the medical community, stay tuned to a future blog.

References

  1. GlobalData Healthcare. Trial resumptions slowing due to new Covid-19 strains. Clinical Trials Arena. Feburary 8th, 2021. Accessed April 15th, 2021. https://www.clinicaltrialsarena.com/comment/trial-resumptions-slowing-due-to-new-covid-19-strains/
  2. IQVIA Global Executive Briefing on COVID-19. IQVIA Inc. April 22nd, 2020. Updated June 2020. Accessed April 15th, 2021. https://www.iqvia.com/events/2020/04/iqvia-global-executive-briefing-on-covid-19
  3. The Author’s submission Toolkit. International Society for Medical Publication Professionals (ISMPP). Accessed April 15th, 2021 https://www.ismpp.org/assets/docs/Certification/StudyMaterials/groves%20t%202010.pdf
  4. COVID-19: ISMPP issues guidance regarding authorship challenges. The Publication Plan. March 24th 2020. Accessed April 15th, 2021. https://thepublicationplan.com/2020/03/24/covid-19-ismpp-issues-guidance-regarding-authorship-challenges/
  5. Kitchens B. and Hall Megan P. Publication Planning at Smaller Companies: Top 5 Learnings for Success. The Map Newsletter. September 2019. Accessed April 15th, 2021. https://ismpp-newsletter.com/2019/09/24/publication-planning-at-smaller-companies-top-5-learnings-for-success/
  6. Publishing Model. BMJ Publishing Group Ltd. Accessed April 15th, 2021. https://www.bmj.com/about-bmj/publishing-model
  7. Peer Review Policy and Publication Times. Elsevier. Accessed April 15th,2021. https://www.journals.elsevier.com/social-science-and-medicine/policies/peer-review-policy-and-publication-times
  8. For Authors. JAMA Network. Accessed April 15th,2021. https://jamanetwork.com/journals/jama/pages/for-authors
  9. Callaway E. Will the Pandemic Permanently Alter Scientific Publishing? Nature News Feature. June 3rd, 2020. Accessed April 15th, 2021. https://www.nature.com/articles/d41586-020-01520-4
  10. Fraser N. et al. Preprinting the COVID-19 pandemic. bioRxiv 2020. Accessed April 15th, 2021. http://doi.org/dxdb
  11. Rapid Reviews COVID-19. MIT Press. Accessed April 15th, 2021. https://rapidreviewscovid19.mitpress.mit.edu/
  12. 2019 Novel Coronavirus Research Compendium (NCRC). The Johns Hopkins University. Accessed April 15th, 2021. https://ncrc.jhsph.edu/
  13. Redhead C. Scholarly publishers are working together to maximize efficiency during COVID-19 pandemic. Open Access Scholarly Publishing Association. April 27, 2020. Accessed April 15th, 2021. https://oaspa.org/scholarly-publishers-working-together-during-covid-19-pandemic/