The use of clinical study reports to enhance the quality of systematic reviews: a survey of systematic review authors

Background: Clinical study reports (CSRs) are produced for marketing authorisation applications. They often

contain considerably more information about, and data from, clinical trials than corresponding journal publications. Use

of data from CSRs might help circumvent reporting bias, but many researchers appear to be unaware of their existence

or potential value. Our survey aimed to gain insight into the level of familiarity, understanding and use of CSRs, and to

raise awareness of their potential within the systematic review community. We also aimed to explore the potential

barriers faced when obtaining and using CSRs in systematic reviews.

Methods: Online survey of systematic reviewers who (i) had requested or used CSRs, (ii) had considered but not used

CSRs and (iii) had not considered using CSRs was conducted. Cochrane reviewers were contacted twice via

the Cochrane monthly digest. Non-Cochrane reviewers were reached via journal and other website postings.

Results: One hundred sixty respondents answered an open invitation and completed the questionnaire; 20/

160 (13%) had previously requested or used CSRs and other regulatory documents, 7/160 (4%) had considered but not

used CSRs and 133/160 (83%) had never considered this data source. Survey respondents mainly sought data from the

European Medicines Agency (EMA) and/or the Food and Drug Administration (FDA). Motivation for using CSRs

stemmed mainly from concerns about reporting bias 11/20 (55%), specifically outcome reporting bias 11/20

(55%) and publication bias 5/20 (25%). The barriers to using CSRs noted by all types of respondents included

current limited access to these documents (43 respondents), the time and resources needed to obtain and

include these data in evidence syntheses (n = 25) and lack of guidance about how to use these sources in

systematic reviews (n = 26).

Conclusions: Most respondents (irrespective of whether they had previously used them) agreed that access

to CSRs is important, and suggest that further guidance on how to use and include these data would help

to promote their use in future systematic reviews. Most respondents who received CSRs considered them to

be valuable in their systematic review and/or meta-analysis.