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Drug regulators warn against misuse of open clinical trial data

European drug regulators have warned against the possible misuse of clinical trials data if such data is published with open access.

In an article published by journal PLoS Medicine on 10 April, four drug regulation agencies claim that unrestricted access to clinical datasets could lead to misleading results. Their comments are in response to an article by a group of scientists challenging the pharmaceutical industry to justify the secrecy of their clinical data.

“We are concerned that unrestricted availability of full datasets may in some cases facilitate the publication of papers containing misleading results,” giving rise to unfounded health scares, write the officials from the European Medicines Agency and national drug agencies in France, the Netherlands and the UK.

They argue that opening clinical datasets could lead to unreliable studies, as scientists could be tempted to exaggerate drug effects in their analyses of data produced in industry trials.

“Personal advancement in academia, confirmation of previously defended positions, or simply raising one’s own visibility may be powerful motivators” to misapply data, the regulators write, adding that independent analyses can be as “vulnerable to distortion” as those sponsored by the industry itself. “More often than not, ego trumps money,” they say.

The authors recommend developing shared quality standards for meta-analyses and re-analyses of clinical data. “The same standard of openness should apply to all (drug) trial data, whether sponsored by industry, investigator-initiated, or sponsored by public grant-giving bodies. Likewise, the same standard of third-party scrutiny should be applicable to all secondary data analyses,” they suggest.

The regulators admit that clinical trial data should not be handled as confidential commercial information, and should be made more broadly available. However, making such data publicly accessible requires the development of shared standards for the protection of patient data, they add.