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Access to clinical trial data: a new year, a new chapter in the debate

08 January 2013 Cameron Lockwood

With the start of the New Year, I thought I would provide an update on the clinical trial data transparency debate. For while 2013 has just begun, this month marks the start of the British Medical Journal's new policy that will see it publish clinical trial data only for those medicinal products where there is a commitment to make anonymised, patient-level data available (on "reasonable request").

Moves at European level
The latter part of 2012 saw a flurry of activity and commentary which has significantly shaped the course of the debate. In November, the EMA held a workshop on clinical trial data and transparency, with the aim of identifying the practical and legal implications of publishing this data upon completion of the market authorisation decision-making process. Although the Agency has released clinical trial reports upon request since 2010, regulators are keen to move toward raw data sharing of full clinical trial reports, provided that safeguards for protection of personal data, quality standards and rules of "engagement" are in place.

Meanwhile, just the other week, the BMJ (which has campaigned for open access to data and played a key role in the debate) pointed to evidence that the EMA has rejected a quarter of all requests under this policy, since it became operational.

The November workshop identified five different areas where further advice is needed, and which will inform development of an EMA policy on proactive publication of clinical trial data:

  • Protecting patient confidentiality;
  • Clinical trial data formats;
  • Rules of engagement;
  • Good analysis practice; and
  • Legal aspects.

For each of these areas, five dedicated advisory groups will be formed, comprised of members to be confirmed by the Agency in January 2013. These groups will facilitate dialogue between the EMA and all stakeholders, and report their final advice by the end of April 2013.

Developments in the UK
Here in the UK, the debate has spilled over into the political arena, a result not only of the origins of much of the debate in the controversies over the Cochrane review of neuraminidase inhibitors (commissioned by the UK National Institute of Health Research), but also the publication in September 2012 of Bad Pharma, a no-holds-barred critique of the industry by British physician and writer Dr. Ben Goldacre.

At an NHS Alliance conference held in November, the House of Commons Health Select Committee chairman, Stephen Dorrell, announced that clinical trial data transparency will be a priority for Committee discussion during this year. At the same conference, Committee member Dr. Sarah Wollaston commented that the government should have full access to clinical trial data in the context of making purchases for the national health service.

Meanwhile, just last month, the Science and Technology Committee announced an inquiry into clinical trials that will begin early this year. While the remit of this inquiry will encompass the subject of clinical trials more broadly, it will also include a focus on access to clinical trial data. The Committee is currently seeking written submissions pertaining to:

  • Evidence that the pharmaceutical industry withholds such data and the impact on public health;
  • Ways to make clinical trials subject to more open scrutiny, including responsibility for this; and
  • Whether lessons on transparency and disclosure of clinical trial data can be obtained from other jurisdictions.

Some final thoughts
Thus, the debate is now well and truly operating at multiple levels (European and Member State) and via multiple channels. That the issue of access to clinical data has been linked to the purchasing of medicines is noteworthy, as it opens up the possibility that the risk-benefit balance of medicines will in future be subjected to greater scrutiny by payers - an interesting idea given the focus of the new pharmacovigilance legislation on ongoing risk-benefit assessment. Could this debate feed into the drive for greater collaboration between regulators and payers? (As is occurring in the context of EUnetHTA, for example).

None of this is to say that industry has been idly sat by. UK-based GlaxoSmithKline announced in September that it will begin giving access to anonymised, patient-level data from its clinical trials collected since 2007, where there is a commitment to publish any associated research results, and after assessment by an independent panel looking to evaluate the scientific basis of the request and the proposed research protocol. The company already publishes a summary of each trial it conducts on its websites, regardless of whether the results are favourable to the product or not. And, as has been commented by industry stakeholders to date, the industry has a history of sharing data with, and seeking guidance from, external academics and clinical experts, a phenomenon that is only expected to increase given trends toward more collaborative R&D.

In any case, the EMA's policy on proactive publication of clinical trial data is expected to go live in January 2014 - expect further developments in the year ahead!

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