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:
EUCROF believes the proposed approach has a number of advantages: