The European Medicines Agency’s plan to harmonise all clinical trial information requires a significant change in how companies collect and store trial data and records. On 31 January 2022, European Union pharmaceutical legislation known as the Clinical Trials Regulation1 entered into an application – hoping to harmonise the processes for assessment and supervision of clinical trials throughout the EU.
The regulation aims to make it more efficient to carry out multinational trials by enabling sponsors to submit one application via a single online platform – known as the Clinical Trials Information System (CTIS) – that would grant approval to run a clinical trial across several European countries. The regulation also intends to make it more efficient for EU Member States to evaluate and authorise such applications together, via the Clinical Trials Information System. Prior to the new set of regulations, clinical trial sponsors had to submit clinical trial applications separately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial.
The Clinical Trials Regulation1 represents a milestone on the journey to a more competitive European R&D environment, particularly for multinational studies. Improved trial transparency – and EMA has recently opened a public consultation in this area – will make it easier for patients to participate in research. A harmonised approach to clinical trial applications across Europe should lead to faster approvals.
However, despite being given a year’s transition period to adapt to the incoming regulations, companies have been facing challenges in several areas since EU CTR became mandatory for all new starting trials in January earlier this year. Sponsors and contract research organisations (CROs) find it difficult to coordinate submissions cross-functionally and meet tight deadlines, partly due to fragmented and time-consuming data collection. Redactions are another sticking point. Disclosures must be fully integrated within the standard clinical trial process yet occur more frequently across the trial lifecycle than before.
Some issues are outside companies’ control and will only ease once the Clinical Trials Information System (CTIS) reaches a steady state. Still, companies don’t need to wait for the next phase of CTIS to improve their oversight of the complete submission file. Changing the resourcing of their regulatory and clinical teams and adapting their data collection, request for information (RFI), and redaction processes will provide much-needed visibility sooner. The benefits are not limited to EU CTR. Clarifying ownership and creating a single source of trial information would also make rest-of-world studies more efficient.