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Does professional medical writing support impact the quality, ethics and timeliness of clinical trial reporting?

businessman making a note. Internet of Things. Information Communication Technology. mixed media.Over recent years there has been an increased demand for transparency and adherence to best practice guidelines when reporting the results of clinical trials. Findings of a systematic literature review, conducted by Obaro Evuarherhe and colleagues, and recently published in Research Integrity and Peer Review show that:

professional medical writing support is associated with improvements in the overall quality, ethics and timeliness of clinical trial publications.

The review was based on 8 observational studies, which included 849 articles written with, and 2073 articles written without, professional medical writing support. The key findings are summarised as follows:

Professional medical writing support was associated with:

  • increased adherence to Consolidated Standards of Reporting Trials (CONSORT) guidelines
  • increased publication in journals with an impact factor
  • higher mean impact factor of the journal publishing the article
  • higher quality of written English
  • reduced likelihood of reporting non pre-specified outcomes
  • reduced time for complete manuscript development (time from last patient visit in clinical trials to the primary publication).

Professional medical writing support was not associated with:

  • increased adherence to CONSORT for Abstracts (CONSORT-A) guidelines
  • impact of published articles (as assessed by the number of annual citations, annual article views, and Altmetric score).

Although the time for complete manuscript development was found to be reduced with the assistance of a medical writer, findings were inconsistent regarding their impact on the time taken from submission to acceptance. However, as noted by the authors, medical writers are generally not involved with processes conducted during this period. While professional medical writing support was shown to improve adherence to CONSORT, no such association was found with respect to CONSORT-A. The authors speculate that due to word limits, authors may choose to disclose key results rather than methodology and encourage professional medical writers to improve reporting of protocol details in the abstract.

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Summary by Marie Chivers, PhD.

Marie Chivers PhD is a pharmacist and a medical and healthcare writer. Marie can be contacted at mariegchivers@gmail.com.

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With thanks to our sponsors, Aspire Scientific Ltd and NetworkPharma Ltd


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