EUCROF states position on new clinical trials regulation
Friday, November 14, 2014
The European CRO Federation (EUCROF), which represents 300 member CROs, has released proposals on the early publication of clinical trial information, balancing the public’s need for transparency and innovators’ intellectual property and confidentiality rights.
EUCROF is committed to working with regulatory bodies and all stakeholders to help implement the E.U. clinical trials regulation to meet its objectives of stimulating transparent, innovative clinical research in Europe.
EUCROF is seeking to find a balanced approach useful to patients and yet not harmful to European early drug development and innovation, so the clinical trials regulation can achieve what it was intended for: to boost clinical research in Europe, to give patients access to the most innovative clinical research and treatments and to improve existing treatments.
Early phase clinical trials study basic mechanisms and actions of potential new medicines rather than their therapeutic efficacy. Patients and healthy volunteers who participate in these studies usually are not expected to gain any health benefit. In order to provide a transparent approach of public access to early clinical research information, it is proposed to release the information as and when it becomes relevant for patients, healthcare professionals and the public and thereby ceases to be commercially confidential. EUCROF proposed:
- Relevant registration information is made publicly accessible via the E.U. database following clinical trial authorization and prior to study commencement.
- All further publication milestones, such as access to further registration information, summary results and lay summary and general rules for publication (e.g. if a study has been terminated on safety grounds), are clearly defined and justified in each clinical study protocol and approved via the clinical trial authorization.
- In case of any changes to the authorized publication process and timelines, a substantial modification is submitted and, if justified, authorized prior to implementation.
EUCROF believes the proposed approach has a number of advantages:
- It meets patients’ and public need for disclosure of all information when it becomes relevant for the recipients.
- There is a firm commitment by innovators to be transparent and to publish at specified time points.
- The process has regulatory approval.
- It can be modified via substantial modification, if necessary.
- It is the responsibility of the sponsor and investigator to comply with the commitments made, in the same way as complying with all other parts of the clinical trial and its authorization. Competent Authorities are able to assess compliance with the commitments made.
- It follows a tried and tested process of study design, regulatory approval and change management; it would therefore require little (if any) additional administrative effort.
- It is an efficient and pragmatic process which operates in compliance with the clinical trial regulation and its objectives.
- Commercially confidential information is respected.