Professional medical writing support improves the quality of clinical trial reporting, according to a new study conducted by Oxford PharmaGenesis and published in BMJ Open today.
The research shows that compliance with reporting guidelines in medical journal articles almost doubles when medical writers are involved. The quality of written English is also significantly improved with medical writing support.
The study, conducted with independent researchers from the University of Oxford and the University of Split in Croatia, demonstrates for the first time how medical writing support improves the reporting of clinical trials in peer-reviewed journals.
Dr Chris Winchester, Managing Director of Oxford PharmaGenesis, who was involved in the research said, “Full and accurate disclosure of the findings of clinical trials is vital in helping to advance the treatment of patients. This is the first evidence that convincingly demonstrates the value of professional medical writing support in improving the reporting of clinical trials.”
The study used the checklist set out in the Consolidated Standards of Reporting Trials (CONSORT) statement to assess the quality of reporting of randomized controlled trials.
The findings of the study were as follows.
- The proportion of articles reporting at least half of the CONSORT items completely was almost double when medical writing support was provided compared with when there was no such support (39.1% vs 21.1% of articles), and this difference was statistically significant (p < 0.05).
- The proportion of publications with acceptable written English (as rated by peer reviewers) was much higher for articles with medical writing support than for those without such support (81.1% vs 47.9%; p < 0.001).
- The benefits associated with professional medical writing support were unrelated to whether or not the article had received industry sponsorship. Even when restricting the analysis to research funded by industry, articles supported by medical writers were more than twice as likely to report at least half of CONSORT items completely as articles without this support (38.0% vs 17.9%, p < 0.05). Similarly, for articles with no medical writer engagement, funding source had no significant effect on the quality of reporting.
Liz Wager, lead author of the first Good Publication Practice guidelines, and a co-author of the study said, “This publication highlights the professionalism of medical writers. It confirms that they really are experts in reporting research and that their contribution can raise the quality of reporting.”
“The role of medical writers in evidence-based medicine is often misunderstood,” said co-author Dr Richard White, Commercial Director of Oxford PharmaGenesis. “This study provides evidence of the value of professional medical writing support, and demonstrates the need for further improvement in the quality of reporting of clinical studies.”
Award-winning research
The study was awarded the ‘Best in Original Research’ prize when it was presented at the European and Annual Meetings of the International Society for Medical Publication Professionals (ISMPP) in 2015. Follow-on research conducted by Oxford PharmaGenesis and presented in January at the 2016 European Meeting of ISMPP showed that medical writing support increases the impact of clinical trial publications. Articles with medical writing support were typically accepted by more prestigious journals and received more citations in the first year of publication than articles prepared without such support.
