The controlled release of raw clinical-trial data to other professionals through a suitable gatekeeper should not trouble industry unduly.

Indeed, suggest officials from the UK’s Ethical Medicines Industry Group (EMIG), it could prove to be a valuable resource in driving better-designed and more cost-effective clinical development programmes.

All the same, EMIG believes, a public ‘data-dump’ once medicines have been cleared for marketing would be counter-productive, with the risk of sub-standard analyses compromising or even seriously jeopardising patient safety.

EMIG, which represents small to medium-sized pharmaceutical companies in the UK, has pitched into the debate over the transparency of clinical-trial data shortly after the European Medicines Agency (EMA) heard some sharply conflicting views on the issue from industry, regulators, and campaigners for public access at a workshop in London.

The EMA has declared its commitment to the proactive publication of clinical-trial data once a drug has completed the marketing-authorisation process.

Broad-based advisory groups will start working on the key issues raised by the push for more data transparency – protecting patient confidentiality; clinical-trial-data formats; rules of engagement; good analysis practice; and legal aspects – early next year.

Need for clarity

Mark Edwards, R&D director for EMIG, stresses the need for clarity on the EMA’s intentions, particularly in the face of concerns over the potential vulnerability of commercially sensitive intellectual property (IP).  

The agency wants to “release raw datasets of clinical trial data once it has reviewed and provided an opinion (positive or negative) on a submission”, Edwards notes.  

“Its intent is NOT to release any other sort of data, e.g., that relating to IP around the molecular structure, synthesis, formulation, regulatory CMC [Chemistry, Manufacturing and Controls], etc. “

These data “form part of an overall submission and may be commercially sensitive for sure”, Edwards acknowledges.

Commercially sensitive?

Industry’s “main grouse”, he says, is that “there will be commercially sensitive bits of clinical-trial data that shouldn’t be released without company permission”.  

“My question is”, Edwards continues, “‘what are the truly commercially sensitive pieces of clinical trial data?’  If there are areas that aren’t obvious to me, then, are they at least worthy of considering ‘giving up’ in order to access a whole load more data from other sources in return?”

No free-for-all

Edwards is adamant, though, that he is not advocating – as some transparency campaigners have done – a “data-dump free-for-all”.  

Industry should be open to sharing publicly all of the data used to design, execute and report on clinical trials, once a regulatory opinion has been provided on a marketing application, Edwards suggests.  

At the same time, data-sharing “needs to be done in a controlled way, with well-constructed, prospective requests made by an ‘applicant’ to a future ‘gatekeeper’ authority.  Otherwise we’ll potentially end up with anarchy and ‘home brew’ analyses – which, at worst, could seriously jeopardise patient safety”.

EMIG chairman Leslie Galloway echoes Edwards’ concerns about “who gets their hands on the data to do their own analyses”.  

Having a “well-meaning, but less than regulatory-standard re-analysis of benefit/risk could lead to false advice being given to patients”, Galloway warns.  

That calls for “some sort of application process and gatekeeper … i.e., data release should not simply be made available on public websites”.

Benefits to clinical development

Clinical development could certainly benefit from properly managed open access to clinical trial data sets, Galloway believes.  

Among other things, it should enable clinical- trial programmes to be designed more quickly and targeted more effectively to responsive patient populations.

It should also, Galloway suggests, reduce the number of “pointless” clinical development programmes, with benefits to patient safety and R&D-portfolio budget management.

Further cost savings would accrue from “not having to use the same old KOL [key opinion leader] networks as everyone else to help design full development programmes”, he comments.   

ABPI position

The Association of the British Pharmaceutical Industry has issued a carefully worded position statement on the issue, saying more transparency around clinical-trial data “is in the best interests of patients and medicine”.

Nonetheless, this is “a truly global process and in this context, the ABPI must consider the evolution at a global level and in partnership with all relevant stakeholders”.

There is “a great deal more work to be done to find solutions and we are engaging with European and international colleagues as well as many other stakeholders”, the association comments. “We do not have the answers on our own, but our goal is to help find the answers.”