Life Science

By Alex Forrest, Head of Industry Practices and Life Sciences, Chubb Overseas General
 

The Clinical Trials Information System (CTIS) opened to submissions in January 2022 and offers a workspace for clinical trials sponsors in the EU to compile and submit their clinical trial applications. The system was intended to be a single-entry point for submission and assessment of multinational and multi-jurisdictional trials, with a publicly accessible website providing information on clinical trials taking place in the EU and EEA. Submission via this system has been mandatory for new clinical trials applications since January 2023. Twelve months on, how has CTIS been performing and how has it impacted clinical trials insurers in Europe? 
 

Related challenges affecting clinical trials insurers

There are three related challenges impacting clinical trials insurers that we have found to be the most significant. First, since the CTIS rollout, we have increasingly found that CROs tend to assign responsibility for multiple countries or regions in a clinical trial to one co-ordinator, rather than allocating one co-ordinator to each country or jurisdiction in the trial as they did before. This means that the co-ordinator responsible for a clinical trial may not be familiar with the insurance or regulatory particularities of each country within their purview. On a number of occasions, we have dealt with clinical trial co-ordinators who are not based in or familiar with many of the countries in scope. Their gaps in knowledge can further delay the process of collating all the necessary insurance documents for each country. Second, in the recent past we have seen more clinical trial cancellations than usual, which can be attributed to many factors, a significant one being recruitment issues. While a certain number of cancellations are expected due to the nature of clinical trials, the high numbers of cancellations we are seeing may indicate that clinical trial applications via CTIS are being submitted with more countries included than will be utilised. Higher numbers of cancellations mean that the significant amount of work that goes into binding risk in each country for the submission – by insurers, brokers, CROs and sponsors – is wasted. Lastly, an already existing issue that we have often come across – the inconsistency of ethics committees – has been exacerbated by CTIS. As countries have different clinical trial regulations and vary wildly in their application, obtaining approval from ethics committees in some countries is harder than in others.
 

What is the future of clinical trials in Europe?

It is reasonable to assume that the upward trend in cancellations will continue if the CTIS process does not change. Furthermore, it may be the case that pharmaceutical or medical device companies are disincentivised from undertaking clinical trials in certain EU countries. For example, if a sponsor or CRO is aware of a country that has an abstruse ethics committee, they may opt not to include that country in their clinical trial plans. This landscape may also encourage sponsors to conduct a greater proportion of their clinical trials outside of Europe, opting for countries such as Australia or Singapore. The challenges to clinical trials caused by CTIS have shifted the key commercial consideration in clinical trials insurance from premium to service. Because of this, insurers may face barriers to entry in the market if they struggle to offer the quick turnaround required. For insurers like us who are already in the market, they may struggle to maintain their place due to the strain put on their services by CTIS.
 

What can be done to mitigate the common problems in clinical trial approvals?

Like all insurers in this space, at Chubb we are under immense time pressure to fulfil clinical trials insurance requests. As mentioned above, initial requests for coverage often come through very late into the clinical trial planning process, sometimes with only a matter of hours to assess the risk, produce a quote and bind. Insurance is often thought of as the last action to take prior to CTIS submission, but we would advise against this approach. If insurers were part of the clinical trial plan from an earlier stage, it would be more beneficial to customers’ CTIS applications. The more time that insurers have to understand and bind a risk is inversely proportional to the margin for error. At Chubb, we are adept at issuing certificates and policies very quickly, but we would still benefit from longer lead times to prepare the required documents in advance.
 

Conclusion

While the intentions of the new CTIS process are reasonable, the impact of the new system over the last 12 months has been problematic for insurers, CROs and sponsors alike. The labour-intensive practice has resulted in a huge increase in time pressure on those involved in clinical trials approval submissions. The system has also exacerbated existing issues with ethics committees and, again, added more time pressure to respond to their queries. I hope that the CTIS process will be amended to provide more flexibility in the approvals process. If ethics committees were subject to standardisation, that would also benefit clinical trials approvals. Standardisation would enable those applying to better anticipate committee queries and respond quickly –something that is very challenging in the current system.