The response of the industry to the new consolidated EMA clinical trials platform to date is overwhelmingly positive
• The majority of Clinical & Quality leads at Pharma, Biotech and CROs are largely positive about the one-stop portal, which promises to make Europe a more attractive and cohesive market in which to conduct trials.
• 40% have already submitted a CTA via the centralized portal, and over 17% have applications pending, the August 2022 survey has found.
Bio Europe - Leipzig, Germany – October 24th , 2022 - Arriello, a leading global provider of Regulatory, Quality, Safety/PV and Clinical advisory and process support services, has found surprising evidence of strong, early engagement with EMA’s new definitive, centralized registration system for clinical trials, CTIS, despite its use not being mandatory for new clinical trials until after January 31, 2023.
Already, over 90% of pharma and biotech companies polled across the UK, Germany, Switzerland, and the US say they are registered in the CTIS; 40% have submitted a clinical trials application (CTA); and just over 17% have applications pending, according to the survey, conducted in August among 400 relevant Director and/or relevant Functional Heads in Pharma, Biotech and CRO companies.
The new platform and portal are designed to streamline the submission, assessment and approval of trials across EU markets, under the new Clinical Trials Regulation (CTR) which became applicable at the end of January 2022 and will be mandatory for all new clinical trials from January 31, 2023.
The online Censuswide survey, split evenly across the four geographical markets, found that early experiences of the process to be positive – a step in the right direction toward the long-promised aim of easier clinical trial harmonization in Europe.
With the deadline for compliance with CTR and CTIS use looming, it is to be expected that teams will increasingly default to the new platform and process, to remove the risk of having to transition to it part way through a trials program. Overall, 92% of respondents said their organization was planning a clinical trial through the centralized EMA system over the coming six months, with Switzerland then Germany recording the highest responses (98% and 96% respectively).
Speed & efficiency among the key benefits
Of the high proportion of organizations that had already registered a trial through the CTIS, more than a third (37 percent) reported they had found the experience faster/shorter than expected, and 31 percent said the process had been easier than expected. Three-quarters of companies had registered a trial through the CTIS found assessment deadlines had been achieved, rising to 99% of US organizations.
All respondents appeared to have a good grasp of and appreciation for the intended benefits of CTR and the CTIS, ranked as:
1. Faster approvals – an expected advantage for 35% of respondents (rising to 40% in the US)
2. Benefits of a wider group experience – cited by 33%
3. Efficiency of scale – cited by 30%
4. Harmonization of processes – 28%
5. Greater transparency – 28% (rising to 40% of US respondents while falling to 16% of Swiss respondents)
6. Fostering innovation & research – 26% (falling to 16% of Swiss respondents)
7. Supporting more uniform decisions – 25%.
Issues to iron out
Experiences of the new portal haven’t been pain-free, though there was no obvious single point of concern. Source of friction to date include:
• Issues of organizational structure – cited by 38% of respondents overall, rising to 43% of US respondents
• Training/information overload – cited by 36%
• Transition point identification – an issue for 35%
• Fear of the unknown – cited by 33%
• A lack of clearly defined process steps – cited by 33%.
Swiss respondents were least likely to have significant issues, and the UK participants’ responses were most evenly spread across the different barriers. German and US respondents expressed most concern about organizational and process issues.
Commenting on the findings, Kieran O’Donnell, Vice President, Global Drug Safety at Arriello, said, “The response of the industry to the new consolidated EMA clinical trials platform to date is overwhelmingly positive, much more so than anecdotal evidence had suggested. This shows just how much this resource is needed in the European market which many companies have found hard to navigate up to now, due to its diverse requirements.
“It is encouraging to find such an enthusiastic early response, which we hope will continue to bear out as companies use it more actively to process applications for new trials.”
The full survey findings are free to download from the Arriello web site, here. They will also be discussed at a fireside chat at Bio Europe on Monday 24th at 09:30 am.
Arriello has been providing risk management and compliance services to the life sciences sector since 2008. These services include market consultancy, global regulatory affairs strategy and implementation, full and local pharmacovigilance solutions, clinical drug safety and quality and compliance auditing systems.
Headquartered in Ireland, with European operations in Central Europe, our technical team has a combined experience of over 130 years working across the EU, US, LATAM, MENA, CIS, APAC regions and South Africa.
More at www.arriello.com and @Arriello
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