February 15, 2023 PAO-02-23-CL-02
In the late summer, Arriello commissioned a comprehensive survey of European and US pharma companies’ initial experiences of the EMA’s new centralized clinical trials information system (CTIS). 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)1, applicable since the end of January 2022 and mandatory for all new trials from January 31, 2023.
Expectations for the new system have been high — if tentative. Under previous attempts to streamline clinical trial requirements and approval processes under a European Clinical Trials Directive, too much was left to interpretation, meaning that each member state transposed the legislation slightly differently.
The August 2022 survey, conducted by Censuswide, took place at roughly the halfway point between the CTR go-live and the mandatory date for compliance with CTIS for new studies. The intention was to capture the early feedback and experiences of 400 relevant Director+/relevant Functional Heads in Pharma, Biotech and CRO companies (100 each across the UK, Germany, Switzerland, and the US).
While mixed early experiences of the new platform might have been expected, the survey findings have proved remarkably upbeat.
The first surprise was the level of activity already taking place through CTIS by August, given that CTIS use isn’t mandatory until after the end of January 2023. Over 90 per cent of respondents claimed to be already registered in the new centralized system; 40 per cent had used it to submit a clinical trial application (CTA), and just over 17 per cent had applications pending.
With the deadline for conformance 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, so it could be that as the year has ticked on companies have opted to make the switch sooner rather than later.
Overall, 92 per cent of survey participants 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 per cent respectively). Nine in 10 US respondents reported that this was the case. In the UK, 85 per cent had plans to plan a clinical trial through the CTIS over the remainder of the year.
Of those that had already registered a trial through the CTIS, more than a third (37 per cent) had found the experience faster/shorter than expected, and 31 per cent said the process had been easier than expected. Biotechs were most likely to be impressed with the speed of using the new system. Just over three-quarters of respondents whose companies had registered a trial through the CTIS said assessment deadlines had been achieved, rising to 99 per cent of US organizations.
Although experiences of the new portal haven’t been pain free, there was no obvious single point of concern. Issues spanned:
Traditional pharma organizations were most likely to have encountered issues with organizational structure and transition point identification. And, while two-thirds of all respondents claim to have already performed appropriate adaptation to their Quality systems for CTR/CTIS, there is work still to be done.
All respondents appeared to have a good grasp of the intended benefits of the CTIS, confirmed to include:
Biotechs were most switched on by the potential for accelerated trial approvals. For traditional pharma, harmonized processes, increased transparency, and efficiency of scale were the top three expected benefits.
The vast majority (81 per cent) of all respondents said they expected a net increase in the volume of sponsored trial activity in Europe, rising to 94 per cent of US respondents — a third of which said they expected a lot more of this.
While this is encouraging, there is still a way to go in achieving total harmonization of clinical trial vetting across Europe’s diverse markets. Acceptance of the new centralized model appears strong, as well as the belief that harmonization will reduce barriers to performing clinical studies in Europe and make the region a more attractive market overall for new innovation in life sciences.
As the risk of having to transition between systems mid study grows, the number of companies registering clinical trials via the new CTIS is likely to have increased sharply since the survey was carried out in August. The submission, assessment and approval of trials across EU markets through the platform, under the new Clinical Trials Regulation, is soon to become mandatory. The survey appears to show that most pharma and biotech companies are working hard to be ready to reap the benefits.
1. Clinical Trials Regulation, EMA: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation
Nicola Kidman is a Principal Consultant, Regulatory Affairs at Arriello and has over 20 years of EU/UK and International regulatory experience gained via positions in pharma, CROs and consultancy companies. Her expertise spans all aspects of regulatory affairs from early drug development to post marketing support, including clinical trial applications and amendments, clinical development plans, scientific advice, Orphan Drug Applications, Paediatric Investigation Plans, MAAs, and life cycle maintenance support.