Reliance on randomised controlled trials for harms / safety data

This problem is addressed by PRISMA-S, AMSTAR 2 (Q3), ROBIS (P2 D2), and MECIR ((C3 & C26). Data on harms, adverse events or side effects are often not reported in full in the published academic papers for trials. The full side effect profiles for clinical trials will be available through each trial's clinical study report which should be consulted in order to learn the full adverse event profile recorded. There is a dedicated PRISMA extention for systematic reviews of harms.

Articles that support this problem:

Some improvements are apparent in identifying adverse effects in systematic reviews from 1994 to 2011

2013 : Journal of clinical epidemiology

Poor reporting and inadequate searches were apparent in systematic reviews of adverse effects

2008 : Journal of clinical epidemiology

Most systematic reviews of adverse effects did not include unpublished data

2016 : Journal of clinical epidemiology

Assessing harmful effects in systematic reviews

2004 : Bmc medical research methodology

Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses

2012 : Bmj

Challenges in systematic reviews that assess treatment harms

2005 : Annals of internal medicine

Availability of large-scale evidence on specific harms from systematic reviews of randomized trials

2004 : The american journal of medicine

The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias

2018 : Bmj evidence-based medicine

Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews

2014 : Bmj

Room for improvement? A survey of the methods used in systematic reviews of adverse effects

2006 : Bmc medical research methodology

Quality of reporting in systematic reviews of adverse events: systematic review

2014 : Bmj : british medical journal

Comparison of search strategies in systematic reviews of adverse effects to other systematic reviews

2014 : Health information & libraries journal