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 harmonized approach to clinical trial applications across Europe should lead to faster approvals.
However, companies have been facing challenges in several areas since EU CTR became mandatory three months ago. Sponsors and contract research organizations (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.
