EMA will no longer allow pharma companies to keep clinical trial protocols secret
In response to advocacy by TranspariMED and other health groups, the European Medicines Agency has adopted a new transparency policy that will give researchers rapid access to clinical trial designs.
Going forward, study protocols for most clinical trials will be made public on the new European CTIS trial registry as soon as a trial receives the regulatory go-ahead. Until previous plans, pharma companies could ‘defer’ the publication of study protocols for several years after trial completion.
EMA’s move is important because it is impossible to fully evaluate and assess a trial’s results without knowing exactly how that trial was designed.
The new transparency rules will allow health technology assessment bodies, guideline developers and independent researchers to better determine which medicines should be offered to what patient groups.
In October 2023, TranspariMED and other health groups had challenged EMA over plans to allow pharma companies to keep protocols secret for many years. Noting that such secrecy ran counter to European law, the groups argued that:
“For EMA to unilaterally decide to allow sponsors to hide trial protocols for long after the results of those same trials have been made public is unacceptable and is not in the best interests of science, patients, or of furthering medical innovation.”
EMA responded by launching a consultation and changing its approach to so-called 'deferrals':
“One of the key changes of the revised rules is the removal of the deferral mechanism, which allowed sponsors to delay the publication of certain data and documents for up to seven years after the end of the trial.”
Under the new rules:
Study protocols for Phase II-IV trials will be made public the moment the trial is approved
Study protocols for Phase I trials involving children will be made public at the same time as the results of the trial
Study protocols for Phase I trials involving adults will be made public within 30 months of the end of the trial
(Phase I trials are commercially sensitive and have little impact on clinical decision-making.)
EMA aims to fully implement the new rules by the second quarter of 2024.
Till Bruckner, founder of TranspariMED, said:
“We strongly welcome the European Medicines Agency’s new transparency rules. It is encouraging to see the agency responding to concerns from the scientific community and living up to its reputation as a global front-runner in regulatory transparency."
"Rapidly making clinical trial protocols public will benefit both patients and taxpayers.”
The October 2023 letter was drafted by TranspariMED. Revue Prescrire coordinated the group of signatories.