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Sponsors of clinical trials often do not comply with European Union (EU) rules on reporting results, according to a new study.
Researchers looked at more than 7,000 trials for which results were supposed to be reported on the EU Clinical Trials Register (EUCTR).
Only about half of these trials actually had results on the EUCTR within 12 months of trial completion, as is required by the European Commission.
Ben Goldacre, MBBS, of the University of Oxford in the U.K., and his colleagues reported these findings in The BMJ.
The researchers assessed compliance with EU rules, explored factors associated with non-compliance, and ranked sponsors by compliance. The team also created a website for live, ongoing audit of compliance.
The researchers assessed 7,274 completed clinical trials for which results were due and found that 49.5% had results reported on the EUCTR.
Trials with commercial sponsors were more likely to have posted results than trials with non-commercial sponsors—68.1% and 11.0%, respectively (adjusted odds ratio, 23.25; P<0.001).
In addition, sponsors with a large number of trials were more likely to report results than sponsors without a large number of trials—78% and 18%, respectively (adjusted odds ratio, 18.38; P<0.001).
The researchers also said they found evidence of errors, omissions, and contradictory data on the EUCTR. For example, 29.4% of trials marked as “completed” gave no completion date, which prevents ascertainment of compliance with reporting requirements.
Finally, the researchers described the development of the EU TrialsTracker website. This site gives detailed information on the trial reporting performance of every individual drug company, university, and hospital conducting clinical trials in Europe.
The site shows which sponsors are the best or worst at complying with the law, and it gives detailed information on the individual trials for which results have not been reported on the register. The information on the site is updated every month.
Sponsors of clinical trials often do not comply with European Union (EU) rules on reporting results, according to a new study.
Researchers looked at more than 7,000 trials for which results were supposed to be reported on the EU Clinical Trials Register (EUCTR).
Only about half of these trials actually had results on the EUCTR within 12 months of trial completion, as is required by the European Commission.
Ben Goldacre, MBBS, of the University of Oxford in the U.K., and his colleagues reported these findings in The BMJ.
The researchers assessed compliance with EU rules, explored factors associated with non-compliance, and ranked sponsors by compliance. The team also created a website for live, ongoing audit of compliance.
The researchers assessed 7,274 completed clinical trials for which results were due and found that 49.5% had results reported on the EUCTR.
Trials with commercial sponsors were more likely to have posted results than trials with non-commercial sponsors—68.1% and 11.0%, respectively (adjusted odds ratio, 23.25; P<0.001).
In addition, sponsors with a large number of trials were more likely to report results than sponsors without a large number of trials—78% and 18%, respectively (adjusted odds ratio, 18.38; P<0.001).
The researchers also said they found evidence of errors, omissions, and contradictory data on the EUCTR. For example, 29.4% of trials marked as “completed” gave no completion date, which prevents ascertainment of compliance with reporting requirements.
Finally, the researchers described the development of the EU TrialsTracker website. This site gives detailed information on the trial reporting performance of every individual drug company, university, and hospital conducting clinical trials in Europe.
The site shows which sponsors are the best or worst at complying with the law, and it gives detailed information on the individual trials for which results have not been reported on the register. The information on the site is updated every month.
Sponsors of clinical trials often do not comply with European Union (EU) rules on reporting results, according to a new study.
Researchers looked at more than 7,000 trials for which results were supposed to be reported on the EU Clinical Trials Register (EUCTR).
Only about half of these trials actually had results on the EUCTR within 12 months of trial completion, as is required by the European Commission.
Ben Goldacre, MBBS, of the University of Oxford in the U.K., and his colleagues reported these findings in The BMJ.
The researchers assessed compliance with EU rules, explored factors associated with non-compliance, and ranked sponsors by compliance. The team also created a website for live, ongoing audit of compliance.
The researchers assessed 7,274 completed clinical trials for which results were due and found that 49.5% had results reported on the EUCTR.
Trials with commercial sponsors were more likely to have posted results than trials with non-commercial sponsors—68.1% and 11.0%, respectively (adjusted odds ratio, 23.25; P<0.001).
In addition, sponsors with a large number of trials were more likely to report results than sponsors without a large number of trials—78% and 18%, respectively (adjusted odds ratio, 18.38; P<0.001).
The researchers also said they found evidence of errors, omissions, and contradictory data on the EUCTR. For example, 29.4% of trials marked as “completed” gave no completion date, which prevents ascertainment of compliance with reporting requirements.
Finally, the researchers described the development of the EU TrialsTracker website. This site gives detailed information on the trial reporting performance of every individual drug company, university, and hospital conducting clinical trials in Europe.
The site shows which sponsors are the best or worst at complying with the law, and it gives detailed information on the individual trials for which results have not been reported on the register. The information on the site is updated every month.