Publishing scientific data is a cornerstone of a strong medical communications strategy. For a life sciences company, the deliverables that the medical publications team generate are critical tools for communicating clinical data to healthcare practitioners (HCPs). Medical publications teams’ primary responsibilities include developing manuscripts that appear in medical journals, as well as the abstracts that appear on poster presentations during medical conferences. And when a physician discusses a brand with a sales rep, the rep is often armed with promotional claims found in a medical publication.

More often than not, the ability to write scientific content has become essential for landing a role in the life sciences industry, especially in the pharmaceutical and biotech sectors. It’s important for medical affairs professionals to have a strong foundation and understanding of how to write an abstract or manuscript.  The medical writing skillset is important for any medical director, medical writer or scientific communications professional to possess.

Peer-reviewed publications have the power to impact medical practice, drive treatment decisions, and affect patient outcomes. Medical publications play a critical role in generating important information for HCPs. Publications fulfill medical affairs’ mission to generate and disseminate clinical data.

Writing Abstracts

An abstract is a condensed, yet concise, synopsis of a full body of information, such as a clinical trial. Medical publications teams will publish abstracts as standalone documents that summarize the key points of the large body of work. The abstract must sufficiently represent the full paper in a condensed format. Prior to publishing full study results, pharmaceutical companies typically write and submit an abstract to medical journals or conferences who will consider it for publication.

Abstracts must always introduce the purpose and the main point of the full-length article. Not all abstracts will result in full publications, though. An author may never complete a full manuscript, for instance. The medical journal may review the abstract and judge the data unimportant or lacking quality or integrity. Regardless of the reasons, however, the abstract remains a reliable method for communicating data to the medical community.

Good Publications Practices Guidelines

When preparing medical publications, medical affairs teams need to keep in mind the Good Publications Practices Guidelines for Sponsored Medical Research (GPP), which the industry has embraced and adopted to ensure that medical and scientific publications meet high standards for publishing. The most recent guidelines, published in 2015, are known as GPP3. Among the detailed set of guidelines outlined by GPP3, some of the most critical standards include:

• All clinical trials should be reported in a complete, accurate, balanced, transparent, and timely manner.

• Authors must follow all journal and congress guidelines for originality and to avoid duplicate publication.

• All authors should have access to relevant aggregated study data and other information required to understand and report research findings.

• Authors must be publicly responsible for all aspects of the publication, including writing and presentation of the data.

• Authors must accurately report their contributions to the publication.

• All authors and contributors should disclose any relationships or potential competing interests relating to the research and its publication or presentation.

Journal Selection

Selecting the right journal when submitting a manuscript involves evaluating the journal’s strength. The medical journal’s audience, characteristics and, of course, prestige play a role in determining where to submit the medical publication. One of the most important characteristics to evaluate is the journal’s readership.

Some internal factors that medical publications teams consider include:

• Audience: Who should read this manuscript?

• Strength: How strong is the data in the manuscript?

• Speed: How quickly should the manuscript be published to best achieve key goals?

The answers to these questions help guide the medical publications team’s decision on which journal to select. Publications teams should also rely on the authors’ levels of experience to assist in evaluating the journal.

Medical Publications Team Challenges

Organizational firewalls that pharmaceutical companies created between the medical affairs and commercial functions have made it difficult for medical publications to consistently prove their value. Medical publications teams rely on soft metrics, such as message uptake among healthcare providers, overall reach, and general physician feedback to measure success. These metrics are often difficult to measure and present a challenge to winning key stakeholder buy-in.

Externally, The Food and Drug Administration Amendments Act (FDAAA) outlines requirements stating that companies must publish clinical study summaries within 12 months of last patient/last visit. Within that short time frame, medical publications teams face pressure to remain compliant while stretching their limited resources to publish study results on time.

On top of these challenges, medical journals have become more selective with which publications they accept. Not only does the FDAAA require greater speed in reporting results, but medical journals are demanding greater quality. One journal’s rejection of a manuscript can result in several additional months passing before other functions inside the company can use the findings.