- Framework of problems / Comprehensive
- Reliance on randomised controlled trials for harms / safety data
- Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses
Ref ID | 469 |
First Author | B. Hart |
Journal | BMJ |
Year Of Publishing | 2012 |
URL | https://www.bmj.com/content/bmj/344/bmj.d7202.full.pdf |
Keywords |
Harms Grey literature Pharmacological Publication bias |
Problem(s) |
Grey literature excluded Reliance on randomised controlled trials for harms / safety data |
Number of systematic reviews included | 37 |
Summary of Findings | Inclusion of the unpublished FDA trial outcome data changed 46% of the meta-analyses to show a decrease in efficacy of the drug and 46% to show an increase in drug efficacy. One meta-analysis with an unpublished harm outcome changed to show an increase in harm from the drug. The direction of the effect of including unpublished FDA trial outcome data varied by drug and outcome. |
Did the article find that the problem(s) led to qualitative changes in interpretation of the results? | Yes |
Are the methods of the article described in enough detail to replicate the study? | Yes |