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Regulatory


Oslo University Hospital in Norway, one of the authors of the paper ‘Experiences and challenges with the new European Clinical Trials Regulation’. “With the old directive, all the different countries had different legislation,” he adds. “Now, we have Europe as a place where you can run trials in many countries at the same time. Europe was quite fragmented with different regulations, so now we have taken a big step in the right direction.” No change is without its downsides, however, as Lene Grejs Petersen, senior advisor at the Danish Medicines Agency, admits.


“For the European Commission, one good thing is that we all know the deadlines, and they are strict,” she says. “If you don’t make it on time, your application will lapse. Sponsors only have twelve days to assess the questions we send out to them, and there is no possibility to extend. That is one downside. Sponsors are also saying that an enormous amount of documentation must be uploaded to CTIS because they are submitting to all member states in one go, but in different languages.”


A work in progress


Olsen and his co-authors also found that CTR has not yet lowered barriers to entry. Timelines for approvals are still ‘unacceptably slow’, particularly for studies conducted in the context of an evolving outbreak. Furthermore, there is evidence of conflicting application requirements, increased documentation burden, barriers to submitting important modifications, and ‘debilitating’ technical hurdles. “There is a lot of documentation in different languages, but you can’t expect patients to all speak English,” Olsen concedes. “But there are some very unfortunate things about CTR itself. I am an academic and I want to do flexible platform trials – massive trials that are very adaptive, in which you can do many things at once. CTR is not flexible enough to accommodate that.” Requirements for substantial modifications currently have a very serial structure. Once a trial is approved and begun, if a change is made the sponsor must first get approval before making any other changes. In platform trials, changes must happen in parallel; for example, a new country might join the trial, or a new treatment might come in. “Being forced into a serial approach could really hamper trials,” Olsen remarks.


Furthermore, any change in the principal investigator (PI) at one site requires a substantial modification. If a doctor has to go on paternity or maternity leave, for example, the sponsor must apply for a substantial modification that could take three months to approve, during which there is no PI. That could be a real problem for multi-site trials.


Clinical Trials Insight / www.worldpharmaceuticals.net


Regulators are well aware of such issues, but they are bound by the regulations, which are hard to change. Nevertheless, change does happen, as shown by the latest round of updates.


The evolution of CTIS Olsen’s group was one of the first to transition to CTIS and apply for a new trial. “The amount of workarounds was incredible,” he remarks. “Both sponsors and regulators were equally frustrated because things didn’t really work well. We could write a massive book about the errors in CTIS, but it is getting better and they are learning. “They had eight years to prepare CTIS, and in some areas it was obvious they hadn’t tested it enough,” he adds. “We had to do the first transition three times because it broke down twice. We would upload docs and they would get lost. The whole process was problematic.”


“With the old directive, all the different countries had different legislation. Now, we have Europe as a place where you can run trials in many countries at the same time.”


Inge Christoffer Olsen


Looking back, problems were inevitable with a new and highly complex system. It was launched in the knowledge that it had many bugs, which is possibly why few pharmaceutical trials were launched on CTIS in the first year by pharma or biotech companies. As with any new technology, that is standard practice – launch a beta version of the system and improve it with users’ feedback.


9


There is only one year remaining for all ongoing clinical trials in the EU to transition to the CTIS.


Photon photo/Shutterstock.com


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