Life Science Compliance Update

October 13, 2014

Clinical Trial Transparency: Starting Jan. 1, 2015, European Medicines Agency Will Publish Clinical Reports For New Drugs; Individual Patient Data Next

Clincal Trail Transparency 2

On October 2, 2014, the European Medicines Agency (EMA) unanimously voted to publish the clinical reports “that underpin the decision-making on medicines.” EMA will publish data submitted as part of marketing applications starting January 1, 2015. Beginning July 1, 2015, the agency will provide access to reports relating to applications for line extensions of indications for existing medicines. The policy does not apply retroactively, so EMA will only publish new data.  

EMA is the “first entity in the world” to introduce such rules, EMA Executive Director Guido Rasi noted. “This unprecedented level of access to clinical reports will benefit patients, healthcare professionals, academia and industry.”

According to EMA’s press statement, “the publication of clinical reports will also help to avoid duplication of clinical trials, foster innovation and encourage development of new medicines.”  

Under the policy (available here), users who want general information about the data can search and browse on-screen after a simple registration process. Users who want the information for academic and non-commercial research purposes will need to provide more detailed information to the agency, including their affiliations and positions within their organisations. Any information that is considered "commercially confidential" will be redacted from the documents.

EMA notes that the data “will only start to become accessible once the final decision on a given procedure has been reached by the European Commission, which implies a timeframe of about 18 months.”

Further down the line, EMA will consult with various stakeholders to “endeavor to find the most appropriate way to make individual patient data available, in compliance with privacy and data protection laws.”

Controversy

The AllTrials campaign, comprised of the BMJ, the Cochrane Collaboration, and others, has been leading the charge for more clinical transparency. Earlier this year, they criticized EMA’s trial policy because the agency was only going to allow users to view trial data in an on-screen-only option. We wrote about that controversy earlier this year.

In the latest policy, EMA removed the on-screen-only restriction and adopted a more “user-friendly” approach which will allow users to download the information. “Now, the public can either browse or search the data on screen, or download, print and save the information,” EMA states.

While the searchability of the data seemed like the big issue a few months ago, EMA has fronted additional criticism. In addition to the push for transparency, the agency must reconcile pharmaceutical companies' rights to commercially confidential information (CCI).  

According to EMA's statement, “[t]he reports cannot be used for commercial purposes...Information that, in limited instances, may be considered commercially confidential will be redacted. The redaction will be made in accordance with principles outlined in the policy’s annexes. The decision on such redactions lies with the Agency.” Many argue that the definition of CCI is very unclear. 

EMA stresses how infrequently a CCI determination will actually limit what users will be able to see. In their policy, EMA states that certain aspects of reports "MAY contain CCI and, therefore, MAY be redacted. It should be noted that NOT ALL the information in the sections...will be redacted but only the SUBSET of the text considered being CCI" (capitalization included in the report).  View the appendix describing what EMA designates commercially confidential information on page 8 of the document

AllTrials, however, believes this gives too much power to the companies. The policy puts primary responsibility for redacting information into the hands of companies, AllTrials states, meaning they get to suggest which information submitted to the EMA should be kept hidden. Furthermore, the campaign notes that the "Terms of Use" that companies and independent researchers must sign allows trial sponsors to take direct legal action against researchers for possible violation of the Terms. They are concerned that trial sponsors can sue independent researchers, which they argue "puts a chill on independent research.” Outsourcing Pharma notes this may mean higher legal costs for contract research organizations (CROs).

The Agency is also involved in a separate process to make summaries of the results of clinical trials publicly available through the EU Clinical Trials Register.

August 13, 2014

European Medicines Agency Inching Towards Clinical Trial Transparency

The European Medicines Agency (EMA) Management Board has been inching towards a policy on clinical trial transparency. Striking a compromise between opposing stakeholders, however, has proved challenging. The European Union's pharmaceutical regulator has been moving towards a policy since at least December 2010, when EMA promised to disclose on-demand clinical trial data for drugs it had review. The final draft was pushed back from January 2014 to July 2014, and now EMA has stated that they will postpone the formal adoption of their policy until October.

EMA's road to a trial transparency policy has been rocky. On the one hand, they faced intense pressure from the pharma industry to curtail the release of the data. Companies have expressed concern that data will be misinterpreted by non-experts, casting unnecessary doubt on the safety or efficacy of their products. Journalists can occasionally latch onto very rudimentary analyses of complicated issues—especially where healthcare is concerned—and make a mountain out of a mole in a sense. This could block potentially beneficial medicines from development.

Also at issue is the use of data by competitors. Companies worry that their data could be used to find and patent new uses for drugs before the originating company is able to study the data, or that companies in markets outside the European Union may use the data to obtain their own approvals from local regulators. This could disincentive expensive R&D. Last year, AbbVie and InterMune sued EMA to block the release of data. Abbvie sought to protect their "confidential and commercially sensitive information," they noted at the time. While the company noted that it supports transparency of clinical research and safety information "for the benefit of patients and healthcare professionals," it opposes the publication of information "that does not meaningfully contribute to the scientific review or evaluation of our products." (Bloomberg).

On the other hand, pro-transparency groups have hounded the EMA to expand access to clinical study reports. EMA was criticized for "flip-flopping" on its promise for greater transparency when they held a stakeholder meeting about their draft policy in May. AllTrials.net (slogan, "Medicine is Broken, We Need Your Help To Fix It"), seems to be the watchdog of clinical trial transparency. They wrote that the EMA proposal, "to the shock of participants," seemed to be watered down from previous versions.

Namely, AllTrials argued that since EMA backpedaled on its policy, now: (1) clinical study reports would only be available for on-screen viewing and could not be saved, downloaded, printed or shared, (2) substantial parts of the reports could be redacted (hidden), and (3) trial sponsors could redact their own clinical study reports. Most of the press took issue with the trial data being view-only.

This draft policy came on the heels of Abbvie and InterMune dropping their case against the EMA, and EMA stating that they had reached an agreement with the companies on a policy. AllTrials seized upon what they deemed a weak transparency policy and wrote an article entitled, "Has the EMA made a backroom deal with pharma over transparency?"

New Policy for Clinical Trial Data

Seemingly in response to the criticism of their draft, EMA released a statement in June to clarify their stance on clinical trial transparency. They also note that they are being careful to ensure the policy will not prejudice citizens' rights:

The European Medicines Agency Management Board on 12 June 2014 agreed the policy on publication of clinical trial data, together with more user-friendly amendments proposed by EMA Executive Director Guido Rasi, that will not only allow the Agency to proactively publish clinical trial data that are submitted as part of marketing authorisation applications, but also give the possibility to download, save and print the trial data for academic and non-commercial research purposes. (emphasis added)

EMA noted that the "wording of the policy, including practical arrangements for academic and non-commercial research users, will now be finalized with a view to its adoption by the Board through written procedure by mid-July 2014, and will be effective from 1 October 2014."

The Agency is also involved in a separate process to make summaries of the results of clinical trials publicly available through the EU Clinical Trials Register

June 27, 2014

Clinical Trial Transparency Update: Eli Lilly, Bayer, Boehringer, and BMS Join Pharmaceutical Companies Sharing Patient-Level Clinical Trial Data

Eli Lilly, Bayer Healthcare, and Boehringer Ingelheim have announced their plans to increase access to their clinical trial data. All three are using the website ClinicalStudyDataRequest.com (which currently is down until July 1st) to share clinical study reports and de-identified patient-level data with researchers upon request. They will join GlaxoSmithKline, Novartis, Roche, Sanofi, and ViiV Healthcare, who also use the same portal to manage data requests. Separately, Bristol-Myers Squibb announced that they will be collaborating with Duke University to expand access to their trial data.

Clinical Study Data Request: How the database works

Clinical Study Data Request provides a secure internet portal for researchers to request patient-level anonymized clinical trial data provided by sponsor organizations.

After creating an account on the website, researchers can submit a single research proposal which is then reviewed by an independent review panel who decides whether access should be provided. The panel reviews the proposed science, publication plans, conflicts of interest and the qualifications of the research team. Following approval by the independent review panel, researchers are asked to sign a data sharing agreement.

Eli Lilly's announcement highlights the differences from previous data-sharing sites. "The new portal, www.clinicalstudydatarequest.com, differs…in that access will only be granted after approval of a research proposal by an independent scientific review panel. Lilly will not be involved in the decisions made by the independent scientific review panel."

YODA Project

Medtronic and Janssen, the pharmaceutical company of Johnson and Johnson use Yale's Open Data Access (YODA) as the intermediary for clinical trial data requests. The YODA Project performs independent scientific reviews of investigator requests for Janssen's and Medtronic's clinical trial data, including both Clinical Study Reports and participant-level data.

Duke Clinical Research Institute

Bristol-Meyers Squibb on June 24 announced that they would expand their access to clinical trial data through a collaboration with Duke University.

PhRMA Principles for Responsible Clinical Trial Data Sharing

In January of this year, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) jointly created a new policy that sought to enhance public health through responsible sharing of clinical data. Companies that follow the policy certify that they have established policies and procedures to implement the data sharing commitments. The following list identifies the companies that have provided such certifications to PhRMA as of May 28, 2014:

Clinical Trial Transparency: List of Individual Company Information

Abbvie

Bayer Healthcare

Biogen

Bristol-Meyers Squibb (New- June 24, 2014)

Boehringer Ingelheim

Calgene

Eli Lilly

GlaxoSmithKline

Novartis

Novo Nordisk

Pfizer

Roche

Sanofi

Shire

Takeda

UCB

ViiV Healthcare

If we failed to list your company, please send us the link to your information and we will be glad to add it to this list.

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