Identifying Low-Quality Preclinical Studies

Abstract

See related article, pages 2824–2829. The failure of the NXY-059 development program for acute stroke therapy has been a major setback in the field of neuroprotection. Large pharmaceutical companies are unlikely to finance further trials in this area of research in the foreseeable future. There have simply been too many disappointments.1 Reviewers at the National Institutes of Health have similar concerns and are currently resistant to funding much of this type of work. This is particularly regrettable because much has been learned about how to design and conduct such investigations in the past 15 to 20 years. I think it is likely that if current methodology had been used for several of the drugs that were abandoned along the way, some would have been found to be safe and effective for treating acute stroke victims. The article by Macleod et al2 in this issue is an attempt to identify specific factors that lead to the failure of NXY-059 to be proven useful. It is their contention that low-quality preclinical investigations were, in large measure, to blame, and that they have a method for detecting inferior work. Specifically, they used their Collaborative Approach to Meta …