Science Driven CRO

Science Driven CRO


With or Without a Medical Writer?

The publication of clinical trial results need to be reported in a high quality, comprehensive, and timely manner in order to share useful research findings with the global community. This enables efficient worldwide clinical development and allows both clinicians and patients alike to judge the risks and benefits of treatments they may be considering.

In order to achieve these goals of effective and ethical communication of trial results, sponsors often seek to assist the study authors in their task by employing the services of medical writing professionals who can manage the projects efficiently and provide a clear and logical account of the trial´s findings.

This writing assistance for study authors was the subject of a recently published systematic review and concluded that a medical writer´s assistance was positively associated with the overall quality of reporting. Quality, in this context, was determined as an increased adherence to Consolidated Standards of Reporting Trials (CONSORT) guidelines, publication in journals with an impact factor, a higher quality of written English, and a lower likelihood of reporting non-pre-specified outcomes (Evuarherhe O et al., 2019).

The study also found that working with a medical writer improved the timeliness of publication as determined by a reduced time from Last Patient Last Visit (LPLV) to primary publication.

This study, published in 2019, helps to substantiate previously reported positive attitudes towards the important work of medical writers and shows the difference a medical writer can make when reporting clinical trials.

Further Reading

Evuarherhe O, Gattrell W, White R, Winchester CC. Professional medical writing support and the quality, ethics and timeliness of clinical trial reporting: a systematic review. Research Integrity and Peer Review. 2019; 4:14.

Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Medicine. 2010; 8:18.

Documents need to be written | Europital can write them for you

Contact our Senior Medical Writer, to learn more about how we can help you with all your Medical Writing needs.

Neil Goodman

Neil Goodman, PhD, BSc(Hons) 
Senior Medical Writer

T: +32 9331 6030
E: [email protected]