Upholding ethical and regulatory standards in clinical research
Regulatory and ethical approvals are pivotal milestones in clinical trials, ensuring the safety, rights, and wellbeing of participants, while maintaining the integrity of research.
The ECRAID-Prime project recently received the green light to initiate the adaptive platform trial in European six countries. Following the rigorous approval processes, we caught up with Roderick Venekamp, Associate Professor at the UMC Utrecht and ECRAID-Prime Ethics Work Package lead.
“Ethics in clinical trials are more than just guidelines; they are essential for protecting participants, maintaining scienfitic integrity, fostering trust, ensuring compliance and setting global standards,” explained Roderick.
He elaborated, “Within ECRAID-Prime, this means ensuring that our trial activities in all countries adhere to the ethical and regulatory standards outlined in the Clinical Trials Regulation. This also includes robust security and safeguarding measures to prevent unauthorised access to personal data, and uphold the rights and freedoms of our data subjects and research participants.”
Implemented in 2022, the Clinical Trials Regulation plays a crucial role in upholding ethics in clinical trials within the EU. It aims to create an attractive and favourable environment within the EU for large scale clinical research, emphasising public transparency and safety for clinical trial participants.
“Ethics in clinical trials are more than just guidelines; they are essential for protecting participants, maintaining scienfitic integrity, fostering trust, ensuring compliance and setting global standards.”
- Roderick Venekamp, general practitioner and Associate Professor at UMC Utrecht in the Netherlands.
Upholding Ethics: A collaborative effort
Ethics, emphasised Roderick, is essentially a collaborative effort that spans the entire EU-funded clinical research project, and he works closely with fellow consortium members to ensure ethical tasks and issues are addressed:“The project’s sponsor has sought authorisation to conduct our adaptive platform trial across multiple countries in the European Economic Area (EEA) through the Clinical Trials Information System (CTIS). All our partners and stakeholders have contributed valuable insights on regulatory and ethical considerations and will continue to do so as the trial progresses.”
Roderick also shared that the consortium has appointed Nina Gobat, a social scientist currently at the World Health Orgnisation and formerly at the University of Oxford, as the project’s external independent Ethics Advisor. Nina’s strong background in health, behavioural and social sciences, and her impartial and unbiased oversight will enhance the credibility, integrity and ethical standards of our trial across diverse international settings.
About the ECRAID-Prime trial
In May and June 2024, the EU-funded ECRAID-Prime project has received full regulatory and ethical approvals to initate the adaptive platform trial in primary care in Belgium, Germany, Ireland, Poland, Spain and UK. The team is currently awaiting for approval to commence in France. Recruitment of trial participants is expected to begin in Q4 2023.
Read more on https://ecraid.eu/ecraid-prime/updates.