Transparency law boosts access to medical device data – new study

The registration and reporting of clinical trials of medical devices improved after the passing of a key transparency law, a new study has found.


Comparing 165 pivotal trials of high-risk cardiovascular devices conducted before and after the 2007 FDA Amendments Act was passed, the authors found that trial registration rates increased from 50% to 98%, results posting on the American trial registry leapt from 15% to 85%, and publication in peer-reviewed journals increased from 58% to 85%.


(Confused about what all this means? This overview may help.)


The authors note that “these [transparency] rates are high but lag behind those reported for new drugs”.


Under the 2007 American law, companies and institutions running trials have to register and make public the results of some trials, including all trials covered by the study. While FDA enforcement to date has been weak, the mere existence of the law seems to have significantly promoted transparency.


In the European Union, there are no comparable transparency rules for medical device trials. Existing European transparency rules only apply to drug trials.


Further findings of the study:

  • Non-publication rates did not differ between ‘positive’ and ‘negative’ trials

  • ‘Outcome switching’ decreased from 14% to 4% of trials (p=0.07)

  • Eight unsuccessful trials ‘spun’ their results as positive

  • Only 36% of trials were randomized


The authors conclude that:


“These results suggest that the legislation has improved transparency and unbiased result reporting of clinical trials, potentially mitigating selective publication and outcome reporting, which can thereby ensure that patient care decisions are based on more complete and accurate research.”


“However, there is still room for improvement because 2% of post-FDAAA trials remain unregistered on ClinicalTrials.gov, 15% have not posted their results on ClinicalTrials.gov, and 15% remain unpublished in the peer-reviewed literature. As required by law, rates of registration and reporting of results on ClinicalTrials.gov should be 100%.”


The author caution that their findings “may not be generalizable to all high-risk medical devices and… [we] did not examine reporting or publication of secondary efficacy and safety endpoints.”


The study can be accessed here.


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