October 2021: European Union CTIS Go-live Planning

On 08 October 2021, EMA published a Go-Live plan for European Union CTIS system. On 21 April 2021, following an independent successful audit of CTIS, the EMA’s Management Board confirmed that CTIS is fully functional and meets the agreed functional specifications. The European Commission subsequently issued a Commission Decision which specifies that the entry into application of the CTR and hence the go-live date for the CTIS will be on 31 January 2022.

This CTIS Go-Live Plan provides an overview of the final remaining activities with the aim to:

  • Address the functional and non-functional areas as set out in the CTIS Project Release Plan for go-live
  • Prioritise the development of the sponsor workspace, followed by the authorities workspace and the public portal
  • Set up of a dedicated EMA Service Desk
  • Address operational and procedural aspects in relation to CTIS and supporting systems
  • Prepare extended stakeholder training
  • Support change management
  • Prepare for the initial scope of safety reporting and monitoring in clinical trials

A dedicated training environment will be made available for use by Member States and sponsors. A phased rollout schedule and controlled access based on needs and European Union Clinical Trials Information System CTIS: Go-live Planning. Access will first be provided to Master Trainers enabling them to train users within their organizations. The rollout is foreseen first for Member State Master Trainers mid-October 2021, followed by providing access to Sponsor Master Trainers from mid-November 2021 and thereafter additional Member States and sponsor users in subsequent batches.

July 2021: CTIS Updates

EMA hosted webinar which was open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations.

A recording will be available of the event. The following are the presentations provided by EMA:

  1. CTIS personas and sponsor organisation modelling for sponsor preparedness
  2. CTIS: harmonising the submission, authorisation and supervision of clinical trials
  3. What is needed to work in CTIS: Organisation, Admin and User Registration
  4. Clinical Trials Regulation Why, when, what and how ?
  5. Member State support for sponsor preparedness and adoption
  6. How Sponsors are Preparing for CTIS: Large Sponsor Perspective
  7. How sponsor organisations can prepare for CTIS: The SME perspective
  8. How Sponsor organisations can prepare for CTIS: Academia perspective
  9. EMA training and support for sponsors

May 2021: European health groups demand action over 4,046 missing drug trial results

On May 06th, 2021, TranspariMed reported that according to the EU Trials Tracker, 4,046 out of 13,563 European drug trials (nearly 30%) are currently missing results, in clear violation of transparency rules that require results to be made public within a year of completing a trial. Over four thousand drug trials run in the European Union are currently in violation of European Union transparency rules, leaving large gaps in the evidence base that often make it impossible for doctors and health agencies to precisely determine how safe and effective medicines are, slowing down medical progress and putting patients at risk.

National regulators within each EU country are responsible for ensuring that pharma companies, universities and hospitals make the results of clinical trials public – but many regulators are not even contacting those that break the rules, let alone enforcing compliance.

Further details can be found here.