Article type
Year
Abstract
Background:
Drug approval reports have been made publicly available by both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). To what extent data are useful is uncertain.
Objectives:
The purpose of this study is to determine whether information publicly available from EMA and FDA is easily accessible, provides useful data on efficacy and safety, and whether the information from the two agencies differs.
Methods:
We conducted a cross-sectional study by sampling all new molecular drugs approved between January 2011 and December 2012 from the FDA and EMA websites and pairing identical drug reports from the two agencies. Two researchers independently extracted data about identifiers, efficacy and harms from each report.
Results:
We included 27 pairs of drug reports. Almost all were searchable but the table of contents in FDA reports often did not match the electronic documents' page numbers. The reports contained information about trial methodology but did not include trial registry IDs or investigator names. All but one report contained sufficient information, including efficacy data, to be used in a meta-analysis. Comprehensive information about harms was reported for 93% of the FDA reports (25 of 27 reports) and 26% of the EMA reports (7 of 27 reports). Even though it was beyond our objective, we noticed that the approved indications differed substantially for 15 of the 27 drugs. In 14 of these cases, the EMA was more restrictive.
Conclusions:
Comprehensive data on efficacy and harms are made available by the two agencies. The FDA has more data on harms but the documents are harder to navigate. The FDA seems to approve wider indications for drugs than the EMA.
Drug approval reports have been made publicly available by both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). To what extent data are useful is uncertain.
Objectives:
The purpose of this study is to determine whether information publicly available from EMA and FDA is easily accessible, provides useful data on efficacy and safety, and whether the information from the two agencies differs.
Methods:
We conducted a cross-sectional study by sampling all new molecular drugs approved between January 2011 and December 2012 from the FDA and EMA websites and pairing identical drug reports from the two agencies. Two researchers independently extracted data about identifiers, efficacy and harms from each report.
Results:
We included 27 pairs of drug reports. Almost all were searchable but the table of contents in FDA reports often did not match the electronic documents' page numbers. The reports contained information about trial methodology but did not include trial registry IDs or investigator names. All but one report contained sufficient information, including efficacy data, to be used in a meta-analysis. Comprehensive information about harms was reported for 93% of the FDA reports (25 of 27 reports) and 26% of the EMA reports (7 of 27 reports). Even though it was beyond our objective, we noticed that the approved indications differed substantially for 15 of the 27 drugs. In 14 of these cases, the EMA was more restrictive.
Conclusions:
Comprehensive data on efficacy and harms are made available by the two agencies. The FDA has more data on harms but the documents are harder to navigate. The FDA seems to approve wider indications for drugs than the EMA.