New ICMJE guidelines and their impact on biotech

Currently, and over the past several years, I have enjoyed working with smaller biotechnology and pharma companies, many of which are looking to bring their first product to market. These companies face numerous challenges that medical communications professionals don’t routinely face when working within mid- to large-sized pharma companies. While smaller companies are often “tech rich” they are also frequently “cash poor”. Their top management is focused on minimizing their burn rate and finding new sources of financing, all while trying to successfully navigate their programs through clinical development and regulatory approval.

Because of this focus, they simply don’t have the infrastructure in place that we typically associate with implementing a medical communications plan to support a future product launch. Browse the employee job titles on LinkedIn for most any small biotech and you’ll find that the preponderance of scientific positions are in regulatory or clinical R&D, whereas personnel with a background in medical affairs and medical communications are often lacking. These companies still need to present their data at congresses and publish in peer-reviewed journals; indeed, publishing preclinical, early, and mid-stage clinical data in high-tier journals can be crucial to securing the funding needed to initiate the pivotal trials required for product approval and, ultimately, a reliable revenue stream.

While the scientific staff in small companies are certainly capable of drafting manuscripts, they are neither full-time medical writers nor publication professionals. As professional medical communications experts, we know there is a great deal of care that goes into preparing a manuscript for submission. We must adhere to journal instructions for formatting, content limits, and style requirements; submit required supporting documents (author disclosures, study protocols, SAP, etc.); accurately report primary and secondary endpoints; and maintain fair-balance while acknowledging study limitations. This gets to be quite a list for someone not routinely doing this on a day-to-day basis. In addition, we need to follow Good Publication Practice (GPP) guidelines (1) and International Committee of Medical Journal Editors (ICMJE) criteria for authorship and include appropriate acknowledgments (2).

Based on personal experiences and interactions, we know that many of the scientific personnel inside small companies involved with drafting abstracts, posters, and manuscripts have either not heard of GPP or ICMJE (or ISMPP [3]), or have only a limited knowledge of these guidelines. And therein lies a potential barrier to successful and timely publications for these small, but innovative, companies.

Moreover, that barrier may have just gotten bigger. The updated ICMJE requirements regarding the need for including statements on plans for sharing individual patient-level data (IPD) just went into effect on July 1, 2018. As noted, many biotech or small pharma start-up companies, by virtue of their stage of development, lack the type of personnel who would routinely be abreast of these recent developments.

It seems inevitable, therefore, that some of these small companies will unwittingly submit manuscripts without full awareness of these new criteria. In the best-case scenario, the company submits to a journal that does not mandate data sharing but just requires a statement on whether the company will/will not share data. The submission is returned to the authors for being incomplete and the authors revise their submission to include the required elements of a data-sharing statement. In this case, the review process is only slowed by a matter of days or a week or two. However, in the event they inadvertently submit to a journal that requires IPD sharing, and not just a statement indicating they won’t share IPD, much more time may be lost. These companies are unlikely to develop plans for sharing IPD and will have to submit elsewhere. If the manuscript requires significant formatting revisions before submission to a second journal, substantially more time may be lost. As a result, we suspect that more than one biotech company will experience significant delays publishing cutting-edge research on the promising treatments they have in development.

Next year the situation may become more complicated for these companies because ICMJE is requiring that any clinical trials enrolling patients on or after January 1, 2019 will have to declare their plans for IPD sharing in ClinicalTrials.Gov. Failure to do so will prevent the reporting of trial results in an ICMJE member journal, and probably many other journals that adhere to ICMJE guidelines. While the goal of ICMJE of increasing transparency in the reporting of clinical trial data is laudable, it will also likely have unintended consequences, especially for non-publication professionals trying to report clinical data in a timely fashion.



Kevin Ryder
Kevin Ryder

Senior Vice President, Medical Strategy and Communications at Porterhouse Medical US