In a previous blog I looked at the EU adoption of the ISO Identification of Medicinal Products (IDMP). I mentioned then that Life Sciences companies needed to be aware of other legislation – such as the Clinical Trials Regulation – when planning to meet the new EU regulatory requirements. This changing regulatory environment is something I’ll be discussing during the London date of this year’s Innovation Tour. So, I thought I’d take a closer look at the EU Clinical Trials Regulation (EUCTR) and what it means for Life Sciences companies.
The EUCTR came into force on 16 June, 2014. However, the regulation is based around the EU portal and database, and until the technology is ready, the legislation can’t be enacted. The latest news from the European Medical Agency (EMA) is that implementation is delayed and it will now be mid-2019 before EUCTR will commence.
The agency explained the delay by saying: “This is the most ambitious IT system required by the EU legislation in the last decade, involving a complete EU-wide system to be used for clinical trial applications, urgent safety measures and other notifications to regulators before, during and after the conduct of clinical trials.”
Whatever the reason, this can be seen as a welcome extension to give you more time to prepare for the legislation. It’s designed to create a favorable environment to conduct clinical trials in Europe while delivering the highest levels of patient safety and transparency.
I’d like to concentrate on three key points of the regulation:
- A streamlined application procedure via a single entry point – the EU portal and database – for all clinical trials conducted in Europe.
- A single authorization procedure for all clinical trials across European member states, and one single assessment outcome and authorization per member state.
- The use of the EU portal and database as a single point for the disclosure and transparency for clinical trials data to be published within 12 months of trial completion or marketing authorization.
The trend within the EU appears to be the replacement of directives with regulations. Directives can be individually applied by the member state while regulations are uniformly (well, almost) applied across all member states. Both IDMP and GDPR follow this approach as does EUCTR. Like GDPR, EUCTR will also apply to clinical trials that take place outside the EU if they are used for marketing authorization purposes within it. The result is that most large Life Sciences companies will be affected by this new regulation.
EUCTR: Why is it needed?
The EUCTR should be good news for Life Sciences companies – especially clinical trial sponsors. It is an admission from the EU that the previous directive was flawed. In fact, the European Commission acknowledges that it led to a significant fall in the number of clinical trials across Europe while increasing the administrative burden and time taken to launch new trials by as much as 90%.
The new regulation aims at simplifying the rules surrounding trials while providing a single point for the application, administration and authorization of clinical trials across Europe. It introduces a lighter regulatory regime for trials conducted with medicines that have already been authorized. The reporting requirements have also been centralized and simplified to reduce a great deal of the duplication in the current system.
Taken together, EUCTR should reduce the time to launch new trails and the cost and complexity of administering the trial and informing the regulators. It is something that should be welcomed by Life Sciences companies that operate in the EU. However, while EUCTR may not represent your largest IT change in a decade, it is certainly a technical challenge that you should address.
A single point of integration
In theory, the EU portal and database is an excellent idea. It’s too early to say what the actual implementation will be, but we all have experience of massive, monolithic public sector IT systems. The challenge for Life Sciences companies is not simply achieving effective integration, it’s the variety of content and documentation that you will be providing to the system.
The new EU portal and database becomes the sole administrative system for for clinical trail submissions – including the submission dossier – all supporting documentation for the trial, the maintenance of applications, the authorization process and the trial notifications process. It will also be the single source of public information of the lifecycle of clinical trials from the initial review to the publication of results.
This, of course, simplifies the previous environment where you would have to submit different information to different systems in different countries. However, it places a greater emphasis on the quality of the data that you are entering into the EU portal and database. With the quantity and regularity that you will be expected to manage your clinical trial data on the system, you will need to implement a system for automating as much of the processes as possible – such as an EIM platform – while ensuring that all information can be quickly retrieved and audited for compliance purposes.
Authorizations and keeping the regulators informed
EUCTR delivers a single point of authorization. You’ll receive one assessment outcome and one authorization for each member state. This is a much improved way of working. But, this new system does require that you keep the regulators informed. In fact, there is an extensive series of notifications that you have to deliver including:
- Start of recruitment
- First patient per country
- First visit per country
- End of recruitment
- Last patient per country
- Last visit per country
- End of recruitment
- Temporary halt or suspension
- Early termination
The most effective means of complying with these EUCTR stipulations is through an automated notifications solution backed by a policy that sets out communication flows between all parties involved in the clinical trial and the regulators.
This is especially important as regular and timely communication is an essential part of the submission and modification process. If the Life Sciences company doesn’t respond to requests of information or clarification to set timescales can result in the submission being removed. On the flip side, if the member state misses the deadline than it is deemed to have given ‘tacit agreement’ and the application is automatically approved.
Meeting your transparency obligations
A major part of EUCTR is the increased transparency of clinical trial data. The regulation seeks to increase the transparency of data regarding clinical trial results and outcomes. You will be expected to publish both a summary and lay summary of the results – positive and negative – within 12 months after the end of the trial or at key milestones if it is a post-marketing trail or low-intervention trial.
The benefits of increased transparency are well understood. Deloitte points to a 2104 study of doctors which showed that 81% felt that drug manufacturers had a ‘moral duty’ to make clinical trial data publicly available. 87% thought increased scrutiny of data would lead to better science and research.
Leaving aside the issue of commercial confidentiality – which is provided as an exception within EUCTR – the ability to share and learn from clinical trial data can help improve the performance of trials and cut down on the duplication of effort amongst researchers and Life Sciences companies as a whole. It also helps to build public confidence and trust which is a very good thing for the long term.
However, this places an onus on you being able to ensure the quality of the information that you make publicly available. Life Sciences are going to have to publish far more clinical trial data – submission dossier, clinical results summary, lay summary, etc – than you ever have before. This requires developing new cross-functional processes and information flows to ensure that only the correct information – that’s up-to-date and accurate – is published to ensure compliance while ensuring the confidentiality of all other data.
To effectively meet your transparency obligations requires an EIM platform that can identify all relevant data and content across a wide range of internal and external systems as well as enabling the management and compilation of that information for automated disclosure.
If you’d like to know more about how the changing EU regulatory environment is affecting Life Sciences companies, please join us during our Innovation Tour 2018.