Supporting policies aimed at accelerating and facilitating clinical research in the oncology space
ESMO is committed to supporting the establishment of policies - at all political levels - to enable clinical trials in oncology, thus encouraging the development of innovative new treatments that benefit patients with cancer.
In the European Union (EU), the Clinical Trials Regulation provides rules harmonising the processes for assessment and supervision of clinical trials (with the evaluation, authorisation and supervision of clinical trials remaining the responsibility of individual countries). It as such aims at creating a more favourable environment for research in Europe, as well as maintaining the highest level of standards for patient safety, and increased transparency of clinical trial information. The Regulation also simplifies the rules on safety reporting.
ESMO welcomed the adoption of this legislation in 2014, which entered into application on 31 January 2022. The Clinical Trials Regulation replaced the 2001 EU Clinical Trials Directive.
The entry into application of the Clinical Trials Regulation also marked the official launch of the Clinical Trials Information System (CTIS). CTIS enables sponsors of clinical trials to apply for a clinical trial in up to 30 EU and European Economic Area (EEA) countries with a single application (applications had to be submitted separately to competent authorities in each country prior to the new Regulation). Information on the authorisation, conduct and results of each clinical trial carried out in the EU/EEA is also being made publicly available through CTIS.
A 3-year transition period is currently ongoing during which sponsors of clinical trials will have to transition towards the CTIS. As from 31 January 2025, all ongoing clinical trials will have to have been transitioned into the new system.
ESMO works on keeping medical oncologists informed of the regime for clinical trials established by the Clinical Trials Regulation and held two webinars on how the EU rules impact the oncology field:
- The Clinical Trials Regulation and Its Impact on Oncology
- The Clinical Trials Regulation - Challenges and Burdens Affecting Non-Commercial Research
At the global level, ESMO contributes to the World Health Organization (WHO) initiatives on clinical trials: