Have you heard the buzz around the new European Union Clinical Trial Regulations (EU-CTR) for transparency and disclosure of clinical trial data? The goal of the EU-CTR is to create a more favorable environment for clinical research in Europe, as well as maintain the highest patient safety standards, and increased transparency of clinical trial information for both research participants and the scientific community.
The European Medicines Agency (EMA) released these regulations in early 2022, giving pharmaceutical companies a year to pilot programs and prepare for full implementation. Starting in January 2023, all new clinical trials submitted to the EMA must be compliant with EU-CTR.
If you haven’t had time to digest hundreds of pages of regulations, guidances, and updates, you’re not alone. In smaller biotech companies where every team member wears many hats, it can be difficult to tell which aspects of the complex regulations apply to your work.
To summarize, new EU-CTR regulations will require more work from Sponsors to ensure that they are appropriately disclosing information to the public. Here are the three main ways in which EU-CTR will impact Sponsors and require new processes and workflows.
1. All Trial Information will be Submitted through a New Database
The most overarching and immediate change established in EU-CTR is the implementation of the Clinical Trial Information System (CTIS). The CTIS will replace EudraCT as the EMA’s electronic database. With this new system come new requirements, forms, and fields for registering trials and posting results. EMA recommends that sponsors begin training and familiarize themselves with CTIS now, to prepare for 2023.
2. Plain Language Summaries will be Required
For the first time, Plain Language Summaries (PLS) or “Lay” Summaries will be required for every clinical trial conducted in Europe. PLS ensure study participants are informed about study results and that they understand the value of their contribution to science and public health.
Not only does this add the creation of another document to the regulatory process, it also adds another deadline: a PLS must be submitted within 12 months of protocol-defined trial completion (6 months for pediatric trials, and 30 months for non-therapeutic Phase 1 trials).
It may seem like authoring a PLS is easy; after all, this document should be written to a middle school reading level. However, there is a science (and an art) to distilling complex technical documents down to a few pages of objective, impactful information. Anyone authoring a PLS should be familiar with the European Commission’s “Good Lay Summary Practice” (GLSP) guidance. GLSP provides recommendations around PLS length, layout, graphics, translation, patient engagement and dissemination, all with the goal of enhancing communication with the patient populations we serve.
3. New Documents will be Subject to Public Disclosure
Prior to EU-CTR, Sponsors typically did not worry about publicly disclosing sensitive documents until they were ready to file a marketing application. Under the new regulations, a full list of study-level documents is subject to public release, including: Protocols, Synopses, Investigator’s Brochures, Investigational Medicinal Product Dossiers, and more. This means that sponsors need to redact and/or anonymize Personal Protected Data (PPD) and Company Confidential Information (CCI) in these documents prior to public disclosure.
Meeting the threshold for protecting your patients’ privacy and your company’s intellectual property can be very difficult, especially as EMA doesn’t provide a clear ruleset for what qualifies as protected information. Many times, Sponsors learn this ruleset through numerous interactions with the Health Authority. Companies must balance redacting and anonymizing enough data to protect their patients and their intellectual property while still preserving data utility for the research community.
Achieve Compliance with Certara
Certara Synchrogenix can support all your EU-CTR needs as a leading technology and services provider with expertise in transparency and disclosure. Our full suite of transparency & disclosure services includes expert Plain Language Summary authoring, technology-enabled Anonymization & Redaction, and clinical trial registration & results posting management services.
Our years of experience in successfully supporting programs across regions, as well as our exclusive team of experts, are ready to help you meet and exceed your compliance requirements. Click below to learn more about our transparency and disclosure solutions and to contact us.
