Details Missing in Clinical Trials Directive

Written by Gillian King, Head of Global Consulting, Global Professional Services, CSC Life Sciences

Change – especially when change implies harmonisation, standardisation, and streamlining – can be a good thing. But when Europe’s Clinical Trials Directive was discussed at the recent TOPRA (The Organisation for Professionals in Regulatory Affairs) symposium the underlying theme was a lack of details.

Since the Clinical Trial Directive first came into being there’s been broad agreement that changes needed to be made and that it was a good thing. But the overriding feedback to the TOPRA panel on 1st October was that in the last two years, not a lot has happened.

Multi-National Approach
The biggest difference with the proposed changes lies in how multi-country clinical trials are going to be managed. Currently, companies have to get approval from each EU country in which they wish to conduct a clinical trial, and not only do they need approval from the national competent authority but also from the ethics committees. EMA wants to harmonise the process to enable centralised approval of everything. That’s a good thing. The problem is, no one has any details on how it’s going to work!

Another positive is that if the authorities don’t approve or respond in a timely way, it implies tacit approval, which is fantastic because some of the resource strapped European countries would be slow getting back to companies about a clinical trial. All of these things help to get a standard, streamlined clinical trial process across Europe, which is very good for industry.

There is a caveat to that -- there are treatment standards that occur within countries that will still apply under the purview of any medical authority in a national country. But industry can work with that. It really does help reduce the need for all of the staff or affiliate involvement in clinical trial, and helps move the industry to a standard – and thereby centralised -- European way of doing things.

One potential concern industry has is that the concept of tacit approval will promote a culture of objecting. I think that speaks directly to the fear that exists within industry of anything that’s new, but also to the lack of details. What we need is a greater understanding of how the health authority will play its part in any multi-national clinical trial authorisation procedure.

Portal Pain
Another big change is the introduction of a European portal. How many times have we heard that expression, that there will be a European portal? The problem is no one knows what platform it is, how it will be built, there’s not even one to test.

This makes industry very nervous. As soon as industry hears the word portal it becomes uneasy, because experience has shown us that these things get delayed, they don’t work, and it puts additional burden on companies to train their staff. Again what’s missing? Details!

Taking Time
Although the changes proposed create a timeline for approvals, no time has been allowed for the actual harmonisation aspect of the Clinical Trials Approval process. With such short timelines, no time has been allowed for discussion between the member states. And again, experience shows that when you’re talking about 27 member states and however many a company might be selecting for its clinical trial, each state will argue and need a lot of time. The fact that this hasn’t been figured into the proceedings is a big concern.

Another issue that’s creating concern is what happens if a company gets a yes/no agreement, with some countries agreeing and others not? If one member state doesn’t want to go ahead with the trial does it kill the whole procedure? This is the same as in the centralised procedure with marketing authorisations, and we’re used to this way of working. Even though everyone is at great pains to point out that these proposed changes are not ‘a centralised procedure’ per se, some of the details on withdrawals and member state responsibility seem decidedly lacking.

Awaiting Certainty
Overall, the changes to the Clinical Trials Directive are to be welcomed because it’s a regulation and we always complain that we don’t have enough regulations, just guidances. The problems that arise are short timelines and the need for details, details, details. What’s going to happen? How is it going to work? At the moment, it comes across as a try-and-see project, and regulatory affairs people and the industry generally doesn’t like waiting and seeing and trying something. And that’s because no one wants to be first to try for fear of jeopardising their clinical trials. Also, what will happen during the transition phase? Pick and Mix? We all know how that would turn out …

There’s plenty to be positive about. TOPRA, EFPIA, the European groups generally are actively engaging in discussion around the directive. But the health authorities really need to bring out clearer instructions as to how they will operate, as well as how industry fits into this. The devil, as they say, is in the detail.