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There is good evidence that trial reports in academic journals represent an incomplete picture of the data collected, and are an unsatisfactory source of information. Our recent Cochrane review highlighted the existence of unpublished data (which often contains negative data) for newer oral anticoagulant drugs, which has net been assessed, and there are reports of several side effects related to GLP-1 analogues and newer anti-obesity drugs that have not yet been reviewed. We are therefore planning a series of complex systematic reviews that include regulatory documents and Clinical study reports to evaluate new drugs and some technologies in wide spread use where there is uncertainty about the benefit and harms profiles

Planned Reviews

3.1 What are the benefits and harms of cholesterol lowering drugs to prevent CVD based on clinical study reports and summary of regulatory comments? (Stage 1 review)

3.2 Do new oral anticoagulation drugs in patients with Atrial Fibrillation improve outcomes? (SR of CSRs and Regulatory comments)

3.3 What are the benefits and harms of Glucagon-like peptide-1 (GLP-1) [1] analogues in the summary of regulatory comments)

3.4 Benefits and harms of Mysimba® (naltrexone-bupropion) in the management of overweight and obesity: a systematic review and meta-analysis of unpublished clinical study reports

Onakpoya I , Spencer E, Stuart B, Aronson J, Mahtani K, Heneghan C

(Link to Protocol

3.5 What is the role of genetics in primary care? A critical interpretive synthesis of current attitudes towards genetics in primary care, and a review of therapeutic areas with the potential to benefit from genetic profiling.

3.6 Using Pedometers to Increase Physical Activity and Improve Health

Additional review outputs

Factors and variation driving inappropriate opioid analgesic prescribing in the community: a systematic review

Georgia Richards, Carl Heneghan, Kamal Mahtani, Ben Goldacre

(Link to Protocol

 Workstream leads

Igho Onakpoya (Oxford); Carl Heneghan (Oxford), Ben Goldacre (Oxford), Nadeem Quereshi (Nottingham)