Jack Wilkinson is a Senior Lecturer in the Centre for Biostatistics, University of Manchester. His research interests cover the application, development, and criticism of methods for the evaluation of health interventions, with a particular interest in interventions for the treatment of subfertility, including assisted reproductive technologies (ART). He is a Statistical Editor for Cochrane Gynaecology and Fertility, Fertility and Sterility, and BJOG: An International Journal of Obstetrics and Gynaecology. He has a background in undertaking integrity investigations for scientific journals and publishers,  and leads the NIHR-funded INSPECT-SR project, which has developed a tool for identifying ‘problematic’ randomised controlled trials, including those subject to data fabrication or falsification. He is currently working on the implementation of INSPECT-SR as well as the adaptation of the tool for different contexts.

ABSTRACT:

Problematic clinical trials and the threat to evidence synthesis

It is now clear that many systematic reviews of health interventions and clinical guidelines have been corrupted by the accidental inclusion of “problematic” clinical trials, including those subject to data fabrication or falsification. The introduction of new trustworthiness tools to help reviewers identify these problematic trials are welcome. There are nonetheless challenges with implementing these tools at scale. These include challenges relating to feasibility, as well as risks relating to misunderstanding and misapplication of the tools, resulting in erroneous assessments. There is also a concern that some widely-promoted methods for assessing trustworthiness of published research lack face validity and may be methodologically unsound. I will discuss these challenges as they relate to systematic reviews and will make recommendations to facilitate reliable trustworthiness assessments.