Why trial only reviews can miss harms

Transcript

When systematic reviews of semaglutide or tirzepatide rely on randomized trials alone, they can miss important harms. The trials may include too few people to detect rare adverse events, and they may end before delayed harms appear. Published trial reports can also leave out a lot of adverse event information, so the safety picture can look cleaner than it really is. Reviews should therefore go beyond trial reports and bring in post marketing surveillance, spontaneous reporting systems, epidemiologic studies, and unpublished trial data when available. Harms, eligible study designs, relevant patient risk factors, and the length of follow up should be set in advance. Review authors should also report how much adverse event data were unavailable, and downgrade certainty when substantial unpublished data cannot be accessed.