Tuesday, February 05, 2013

Come on ABPI! Get with the programme.

ABPI holds to conditional release of clinical-trial data

While clinical study reports for all medicines currently in use should “in principle” be available to the public, the company responsible must be involved in identifying which elements of those data “should not be disclosed due to data privacy concerns or to protect commercially confidential information”, insists the Association of the British Pharmaceutical Industry (ABPI).

The ABPI was clarifying its position in the ongoing debate over clinical-trial data transparency under increasing pressure from AllTrials, the transparency campaign backed by epidemiologist and Bad Pharma author Dr Ben Goldacre, the BMJ, the James Lind Initiative, the Centre for Evidence-Based Medicine and Sense About Science.

AllTrials, which sent the ABPI some specific questions about its stance on the release of clinical-trial data after claiming the association had been evasive in its previous responses to the campaign’s queries, wants to see the publication of study reports from all clinical trials conducted since the 1990s on treatments currently in use internationally, as well as registration of all clinical trials.

The ABPI says it believes more transparency around clinical-trial results, and “appropriate access to trial data, past and present, are in the best interests of patients and medicine. It also suggests there is “much common ground” with AllTrials on these issues.

Nonetheless, the association continues to resist a wholesale ‘data dump’ and to counsel prudence until the European Medicines Agency’s (EMA) working groups report on the mechanics of releasing trial data later this year.

Prioritise studies

Asked by AllTrials whether it agrees clinical study reports for all treatments currently in use should be publicly available, the ABPI says industry would “urge civil society to prioritise what studies are most important to release”.
It is “simply impossible for regulators and companies to release all study reports at once”, the association continues.

“Companies would rather spend time developing new medicines than going through millions of pages of historic data. Also, there must be a process of co-ordinating this process among the regulatory agencies – the same study reports have been submitted to agencies all around the world.”

Data exclusivity

The association generally favours redaction of patient-identifiable data or commercially sensitive information rather than withholding study reports.
All the same, it does emphasise the importance of data- and market exclusivity as a lever for research and development investment.

When a company does not hold a patent on a product, “it relies on ‘regulatory data protection’ to get the necessary market exclusivity to recoup the investment made”, the ABPI comments.

“This period is 10 years in the EU. If the entire file with all studies is released other companies can get approvals around the world.”

Commercial plans

One complication, the association says, is that, until now, clinical study reports have been “written for a regulatory audience and assuming confidentiality, they may describe commercial plans of the company”.

For example, a report may set out the development strategy for future studies on new indications for a drug “to put the particular study in context”, the ABPI explains.

In some cases, it adds, companies “may consider that a particular study design is a trade secret that competitors can learn from. Furthermore, study reports often include appendices with detailed information on analytical methods (chemical and physical) and on the manufacturing of the clinical trials material”.

The ABPI’s “overarching belief is that greater transparency of clinical trial information is in the best interests of patients,” it states. “We are supportive of the EMA’s efforts to identify the best way to do this and are engaged in the discussion on how it can be done.”


No comments: