europeanpharmaceuticalreviewAugust 13, 2019
Tag: trial , clinical , medical , writers
A new review has concluded that professional medical writers improve the quality and speed of clinical trial reporting.
The systematic review by researchers at Oxford PharmaGenesis and Ipsen analysed eight studies that included 849 articles written with professional medical writing support and 2,073 articles written without professional medical writing support.
The results showed that professional medical writing support is associated with increased compliance with Consolidated Standards of Reporting Trials (CONSORT) guidelines and with reporting of fewer non-prespecified study outcomes.
"Our research shows that professional medical writers have a positive role in the dissemination of data from clinical trials, improving both the quality and the timeliness of reporting," said Dr Obaro Evuarherhe, Principal Medical Writer at Oxford PharmaGenesis and lead author of the article. "Timely and transparent reporting of clinical trial results is important because it helps to eliminate duplicative effort and reduce waste in research funding.
This is an ethical imperative as it enables researchers to develop more up-to-date hypotheses, and allows clinicians and patients to judge the benefits and risks of different therapies."
Professional medical writing support was also found to be associated with a reduced time from clinical trial completion to primary publication. However, the results were mixed for one stage of manuscript development, from submission to manuscript acceptance, with one study suggesting that professional medical writing support increased time to acceptance but another study showing no effect.
An improvement in the quality of written English used in articles and a higher mean impact factor of the journals publishing these articles were also associated with professional medical writing support.
"The pharmaceutical industry is leading the way in clinical trial transparency, thanks in part to the support of professional medical writers," added Dr William Gattrell, Global Medical Publications and Communications Manager at Ipsen and co-author of the article.
The review was published in Research Integrity and Peer Review.
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