Life Science Compliance Update

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December 17, 2013

Increased Clinical Trial Transparency in US and Abroad

Over the past several months, the European Medicines Agency (EMA) has been focusing on making the results and data of clinical trials more transparent. For example, last year we wrote several stories about GlaxoSmithKline making its clinical trial data public.

This topic has been hot in many areas of the world, including Canada and the United States. Regulatory Focus reported back in April of this year that "Health Canada will soon make public key information on clinical trials conducted by industry in the country, introducing a measure of transparency that is ultimately meant as a half-step toward still greater measures."

More recently, FDA proposed making product approval applications more transparent as well. Consequently, FDA re-opened the public comment docket on its proposal to bring more transparency to clinical trials in the beginning of October. Comments are due October 31, 2013.

Consequently, PharmaTimes recently reported that the EMA has "launched an updated version of its European Clinical Trials Database (EudraCT), clearing the way for the agency's long-promised goal of making summary clinical-trial results publicly available through the EU Clinical Trials Register (EU CTR)."

The EMA said the launch of EudraCT V9 "marks the initial step of a process through which summary clinical-trial results will be made publicly available through the EU Clinical Trials Register", the article notes.

"EudraCT already contains protocol-related information submitted by sponsors for interventional clinical trials conducted in European Economic Area countries, and/or for those conducted in third countries where the trial is part of an agreed Paediatric Investigation Plan, the agency notes."

Clinical-trial sponsors are being "encouraged" to register on the EudraCT website so they can begin uploading summary results, the article notes. "These results will start to be available to the public once the EMA has launched the complementary new version of the EU CTR towards the end of this year, it notes."

"Mandatory posting of summary results, within the terms set out in a European Commission guideline published last year, will not take effect until the middle of 2014, once the EMA has made further updates to the system to improve functionality for both trial sponsors and EU regulatory authorities."

"With the launch of these further iterations of EudraCT by mid-2014, the modalities and timing of posting of result-related information as described in the EC guideline will apply, and sponsors will then be required to post result-related information," the agency states.

The Commission's guideline, Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006), was published in the Official Journal of the European Union in October 2012.

Retroactive results

While the new EudraCT feature will "allow sponsors to provide summary results of all interventional trials already published in the EU CTR", some critics believe the EMA's effort only go part of the way in addressing concerns "about the lack of retroactive information on clinical trials in Europe."

"Campaigners such as AllTrials have complained about what they see as the EMA's foot-dragging on the EU Clinical Trials Register, as well as the register's limited scope (only Phase II to IV trials included)." These groups have also called for "measures to ensure that, at the very least, summary results from all past trials of medicines currently in use are immediately made available to the public through a clinical-trial register."

Ultimately, "the AllTrials campaigners would like to see data-sharing from trials going back at least two decades to inform current treatment decisions," the article explains.

The article notes that the EMA "plans to introduce from the beginning of next year a tiered system of access to clinical study reports and raw trial data once the agency has published its European Public Assessment Report on an application for centralised marketing authorisation."

"However, that system – which has been challenged by pharmaceutical industry associations on a number of grounds – would not apply retroactively. Nor would provisions introduced in parliamentary amendments to the European Commission's proposed regulation on clinical trials. These would require sponsors to publish full clinical study reports once a marketing-authorisation decision had been taken."

"Under the proposals endorsed by the Parliament's Environment Committee, trials would also have to be registered on a publicly accessible EU database and their main findings reported within a year of the study ending." (This latter provision is in line with the Commission's original text, under which sponsors would have to submit a "summary of results" to the EU's clinical-trial database within one year of a study ending.)

In response to these announcements, drug companies have expressed their concern. For example, a Pfizer official told the Drug Industry Daily that if "EU regulators and pharma cannot agree on how to handle publication of clinical trial data, drugmakers may delay filing applications in the EU to preserve exclusivity."

Speaking during a PhRMA-sponsored meeting of stakeholders in Washington, D.C., Justin McCarthy, a senior vice president at Pfizer and its chief counsel for R&D, said release of potential commercially confidential information could force firms "to make a choice between filing in Europe and potentially losing the ability to get exclusivity in other parts of the world, or filing in those other countries first to preserve exclusivity."

Response to Increased Clinical Trial Transparency

In response to increased calls for clinical trial transparency, the Association of the British Pharmaceutical Industry (ABPI) released an online clinical trial disclosure toolkit to help drugmakers comply with growing transparency requirements, reported FDANews. ABPI posted 11 documents on its website, including:

  • Points to consider when managing disclosure;
  • Process flow maps to map companies' disclosure processes relating to trial registration and results disclosure;
  • A template standard operating procedure on clinical trial registry; and
  • Self-training and Q&A documents.

ABPI hopes the documents will help drugmakers navigate the research landscape, which has become an obstacle course in recent months with regard to data transparency.

However, the group — which represents more than 180 pharma companies — stresses the toolkit "is not intended and should not be construed as regulatory or legal advice."

"ABPI notes that its code of practice already requires members to register current and future trials within 21 days of enrolling the first patient. The organization also requires members to publish trial results within a year of a drug's marketing authorization or a year post-study completion for products already on the market," FDANews notes.

"Research is a truly global activity, with the UK supplying less than two percent of patients to global clinical trials," said ABPI Chief Executive Stephen Whitehead. "As part of a global industry, we are actively engaging with our European and international counterparts, as well as many other stakeholders, to input into ongoing discussions around clinical trial transparency."

Pfizer Launches Clinical Trial Transparency

Pfizer has also announced it is improving its clinical trial reporting. Stating that it will simplify and broaden access to information gathered in Pfizer-sponsored clinical trials.  The updated policy builds upon and expands the company's established methods of clinical trial information sharing, including Pfizer's long track record of submitting for publication results from all interventional clinical trials in patients and its pioneering efforts to provide clinical trial results and data to study participants.

Pfizer's updated policy meets or exceeds the "Principles for Responsible Data Sharing" issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) in July 2013.
 

 

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