Experts offer CTIS advice on eve of transition for new applications

Many pharmaceutical companies in the EU are waiting on the sidelines to submit new clinical trial applications to the Clinical Trial Information System (CTIS) portal. Companies are either waiting for their colleagues to submit first or are waiting for last-minute technical glitches to be ironed out first, said an expert who recently spoke to Regulatory Focus on CTIS implementation.
 
Other experts told Focus that while the requirement to submit all new trials to CTIS is on 31 January, an ongoing challenge is submitting two sets of documents in the portal, one set of proprietary documents that cannot be released publicly and one set of non-proprietary information that can be published.
 
Another issue of concern is that local ethics committees are “struggling” with CTIS implementation amidst resource constraints and the information demands of the Clinical Trials Regulation (CTR). The experts also offered tips to ensure smooth implementation for submitting information to the portal.
 
Companies waiting until last minute
 
Bertrand Fournier, director of regulatory policy and intelligence for Shionogi Europe, said that sponsors are waiting until the last minute to ensure that any lingering bugs with the system are worked out.
 
Fournier said his company decided to wait and let other companies submit first so that any outstanding issues with the system could be resolved. “I know many companies are also doing the same thing,” he said.
 
Fournier also said he is concerned that the system may not be able to sustain the volume of data that will be submitted after the transition on 31 January.
 
He said that so far, uptake has been “very slow” and that only a limited number of trials have been submitted via the portal.
 
“Will the system be able to sustain the amount of users and the amount of data that will be submitted? Nobody knows how robust and strong the system will be … A big question that I have and that has never really been answered by EMA is what if the system crashes on the first or the second of February. What do we do then?”
 
Yet Pierre-Frédéric Omnes, executive director at TransPerfect Life Sciences, and a consultant to EMA on the CTIS portal, was more confident about the readiness of the CTIS system. He said that while the system is far from perfect, major improvements have been made to the user interface this year.
 
“Is it going to be without glitches or bugs? Only time will tell.” He asserted that the system “is better than it was” and that many improvements have been made to the user interface since the launch of the first CTIS system in 2017.
 
EMA retained the 31 January deadline after determining that it can resolve the final “blocking bugs” by the go-live date. (RELATED: Euro Roundup: EMA keeps deadline for CTIS switch, says it can fix ‘blocking bugs’ in time, Regulatory Focus 26 January 2023)
 
Larger companies will be ready
 
When asked their views on whether industry is ready to submit clinical trial data in the new system, experts said the level of readiness varies based on a company’s size and location.
 
Kate Stockman, OTC category lead and senior director for global regulatory affairs for Haleon, asserted that larger companies are ready, while many smaller firms and those companies located outside the EU may not be.
 
“It’s a bit of a mixed bag honestly. For those companies in the innovator part of the sector particularly the larger ones who are conducting tens if not hundreds of studies, then they tend to ready.” She added some of the smaller companies, particularly those outside of Europe, including firms based in China and Asia “are a bit less ready.”
 
Ethics committee readiness a concern
 
Fournier expressed more concern about the readiness of local ethics committee in complying with the document demands of the CTIR and said some ethics committees are inadequately resourced and ill-equipped to handle the document requests.
 
“The ethics committees are very, very small and they are literally drowning in this” and having trouble adapting to the legislation. “They are lost, many of them don’t speak English and are struggling with translations. It is a totally different world.”
 
Member state divergence still a problem
 
Another issue, Fournier said, is that some Member States are either diverging from the CTR while others are requiring additional documents that are not specified in the CTR.
 
Fournier said these divergence issues have been reported to EMA. Yet the agency is unable to act against these countries as this is outside their remit. The European Commission, Fourier said, is “aware of this and are working with the companies to remind them that they are not allowed to deviate from the CTR.”
 
For its part, the Commission is “mindful that NCAs [National Competent Authorities] and ethics committees are struggling with implementation and with resources and computer issues,” Fournier said.
 
Smooth transitions
 
Regardless of these obstacles, experts offered some tips on ensuring a successful transition to CTIS. Stockman said that firms should involve all sectors of their company in preparing the necessary documents for the portal. She said that not having this buy-in cost her company an additional six months when preparing their first submission.
 
Fournier said that companies should ensure they have processes and systems in place for managing the voluminous task of submitting two sets of data to CTIS: one that is confidential and proprietary and those which are redacted.
 
Before the CTR took effect, sponsors only had to submit trial summaries and protocol summaries, now all trial information and protocols must be submitted.
 
Stockman acknowledged that “submitting a non-redacted and a redacted version of the trial has been a challenge.”