Preprints are not new, and neither are the many arguments surrounding them. Nevertheless, they are increasingly being accepted in the life sciences, as many believe that science will benefit more from openness. Tanya Parish, Editor in Chief of Microbiology, mentions, “We recognize the role they (preprints) play in the rapid dissemination of information, similar to posters and oral presentations at scientific conferences.” Kalai Mathee, co-Editor in Chief of Journal of Medical Microbiology, echoes this belief: “Preprints provide a fantastic vehicle for rapid dissemination of significant findings, offer a viable time-stamp to the research, and importantly a fair-attribution of the discovery.”
Now, let’s go over what preprints mean for pharma and medicine.
Why is there skepticism around preprints?
There are numerous concerns about preprints in medicine and pharma. The foremost is that preprints do not undergo a formal peer review, and they are not screened for ethical compliance. There is also no process in place to confirm the novelty and appropriateness of a study. Consequently, readers can be suspicious of the quality of research in a preprint. Pharma-authored research needs to be trusted by healthcare practitioners and the medical community. Thus, pharma may be reluctant to publish preprints. Additionally, although several medical journals accept manuscripts that have been posted as preprints, not all journals do so; this may make the manuscript submission process more complicated for the medical affairs teams.
Furthermore, since preprints are generally not retracted and there are no industry-wide standards for dealing with issues arising due to preprints with problematic content, methods, or results (except in extreme circumstances such as legal issues, ethical concerns, or misconduct, where the paper in question is withdrawn), once incorrect information has been disseminated, it is extremely difficult to revise or make corrections. The preprint might be cited by mistake even after the final article is published in a journal. Yet another issue is that some researchers fear being scooped by peers and predatory publishers. Preprints can also be inappropriately used by competitors by posting research prematurely to “stake a claim” or by commenting negatively on a preprint to criticize the drug or product being described therein and promoting their own instead. As preprints are made available in the public domain, there is no control over feedback with malicious intent.
Moreover, there is the grave issue of premature coverage from ill-informed media, which can increase chances of public misinterpretation. Over 40% of the health care consumers utilize social media for information about their conditions and treatment. While Internet searching can improve doctor-patient interactions without affecting treatment adherence, patient safety can be seriously compromised if patients follow unverified, unreliable, or incomplete studies.
Thus, preprints could be perceived as adding extra work for the already busy pharma teams without improving the quality and efficiency of submissions or the publication cycle. Therefore, although preprint servers such as medRxiv have stringent safeguards in place, pharma has reason to be wary of preprints.
Are there any benefits of preprints then?
The answer is yes. Despite these limitations, there are many advantages of preprints for pharma. Preprints allow early and speedy dissemination of research to a broader audience as they are free and openly accessible. They provide an opportunity for receiving feedback from a much wider audience including the public and peers. This can improve the quality of the manuscript, leading to savings of time and effort for pharma authors during peer review. Preprints also enable publishers to discover cutting-edge research and invite researchers to submit their research to their journals. More importantly, preprints help establish priority of work and discovery for authors by providing a “date stamp” and a public record, which is crucial in medicine and pharma. Preprints can also supplement peer review and are citable as they receive digital object identifiers (DOIs); Crossref has created a category of DOIs specifically for preprints.
What’s the current scenario of preprints in pharma?
It’s understandably difficult for pharma to emulate the trend of preprints followed in other fields. Of the 11,344 medRxiv preprints posted between June 2019 and September 2020, only ~1% had an author from pharma, and even fewer had such an author listed as the first or corresponding author.
However, pharma also needs to get their research out and available to stakeholders faster, especially because of the increasing desire and ability of patients to access health-related information online, as discussed above. While some are exploring the open access route, companies like Roche, Sanofi, and Novartis are already using preprints. Therefore, it is about time for pharmaceutical companies to seriously consider preprints during publication planning and develop strategies and policies around them.