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Res Integr Peer Rev. 2019 Jul 10;4:14. doi: 10.1186/s41073-019-0073-7. eCollection 2019.

Professional medical writing support and the quality, ethics and timeliness of clinical trial reporting: a systematic review.

Author information

1
Oxford PharmaGenesis Ltd, Tubney Warren Barn, Tubney, Oxford, OX13 5QJ UK.
2
Ipsen Pharma, Milton Park, UK.
3
3Oxford Brookes University, Oxford, UK.
4
4Durham University, Stockton-on-Tees, UK.

Abstract

Background:

Many authors choose to work with professional medical writers when reporting the results of clinical trials. We conducted a systematic review to examine the relationship between professional medical writing support (PMWS) and the quality, ethics and timeliness of publications reporting clinical trials.

Methods:

Using terms related to 'medical writer' and 'observational study', we searched MEDLINE and Embase (no date limits), as well as abstracts and posters from meetings of the International Society for Medical Publication Professionals (ISMPP; 2014-2018). We also hand-searched the journals Medical Writing and The Write Stuff (2014-2018) and the bibliographies of studies identified in the electronic searches. We screened the results to identify studies that compared the quality, ethics and timeliness of clinical trial publications written with and without declared PMWS.

Results:

Our searches identified 97 potentially relevant studies, of which 89 were excluded during screening and full paper review. The remaining eight studies compared 849 publications with PMWS with 2073 articles developed without such support. In these eight studies, PMWS was shown to be associated with increased adherence to Consolidated Standards of Reporting Trials (CONSORT) guidelines (in 3/3 studies in which this was assessed), publication in journals with an impact factor (one study), a higher quality of written English (one study), and a lower likelihood of reporting non-pre-specified outcomes (one study). PMWS was not associated with increased adherence to CONSORT for Abstracts guidelines (one study) or with the impact of published articles (mean number of citations per year, mean number of article views per year and Altmetric score; one study). In studies that assessed timeliness of publication, PMWS was associated with a reduced time from last patient visit in clinical trials to primary publication (one study), whereas time from submission to acceptance showed inconsistent results (two studies).

Conclusions:

This systematic review of eight observational studies suggests that PMWS is positively associated with measures of overall quality of reporting of clinical trials and may improve the timeliness of publication.

KEYWORDS:

Adherence; Clinical trials transparency; Medical writer; Medical writing; Reporting guidelines

Conflict of interest statement

Competing interestsObaro Evuarherhe, Richard White and Christopher C Winchester are employees of Oxford PharmaGenesis, Oxford, UK. William Gattrell is an employee of Ipsen Pharma, Milton Park, UK. Christopher C Winchester and Richard White are directors of, and own shares in, Oxford PharmaGenesis Holdings Ltd.

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