A storm is brewing over the release of clinical trial data as GlaxoSmithKline on Tuesday took a step away from UK and US industry groups and said it intends to publish clinical study reports for all approved medicines dating back to when the company was first created in 2000.
The announcement, which aligns the company with the trial transparency effort of Alltrials.net and follows a similar announcement in October , was praised by Member of the European Parliament Rebecca Taylor.
She told In-Pharmatechnologist.com that it’s a welcome move given that negotiations are about to begin on a newly proposed clinical trial regulation in the EU.
The commission's proposal adds a bevy of new requirements where sponsors will have to provide reasons for withdrawing clinical trial applications, and trial data will no longer be considered confidential once a marketing authorisation has been approved, according to Rapporteur Glennis Willmot’s draft report on the proposal released Monday.
The regulation is intended to boost the number of trials in the EU by streamlining the authorization procedure for trials in multiple countries. It also aims to increase transparency by requiring the results of all trials to be reported within one year of their completion, abandonment, or halting because of adverse events, Taylor said.
But the legislation will not retroactively require companies to disclose trial data for drugs already approved in the EU as that isn’t legally viable, Taylor added.
And when asked if she thinks these new requirements will have a chilling effect on trials in the EU and push sponsors to conduct their studies in other countries, Taylor said she didn’t think so. She said the new requirements have been received with a lot of support from universities, non-government organizations, research groups and other sponsors.
The transparency efforts in the proposal, which is expected to come into effect in 2016, will work in tandem with efforts from the European Medicines Agency (EMA) to publish online all clinical trial data that support the approvals of marketing authorizations.
Taylor also noted that the final regulation may extend the amount of time sponsors keep the trial master file beyond the current five years. The file includes all of the information sponsors submit for approval of the trial.
The GSK announcement, EC transparency efforts and calls from the British Medical Journal to release more past data come in stark contrast to what is amounting to a joint effort by the Association of British Pharmaceutical Industries (ABPI) and US industry trade group PhRMA to halt the release of more trial data based on privacy concerns.
“The demands by [Alltrials.net] and the British Medical Journal (BMJ) to release patient-level clinical trial data are irresponsible with potentially harmful consequences for future medicine development,” PhRMA’s executive vice president Josie Martin said. The recommendations “would jeopardize patient privacy” and “also encourage second-guessing of the regulatory approval process, which would be disastrous for patients.”
Similarly, the ABPI said in a statement, “It is simply impossible for regulators and companies to release all study reports at once. Companies would rather spend time developing new medicines than going through millions of pages of historic data.”
But Alltrials.net claims that as many as half of all trials conducted have not been published in medical journals.
The UK government’s health committee also recently called for all trial data to be made public but the details of what will be reported, to whom, and when were not specified.
But the ABPI said it would wait on decisions by EMA working groups before deciding exactly how to release clinical study reports moving forward.