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EUCROF released proposals on the early publication of clinical trial information, balancing the public's need for transparency and innovators' intellectual property and confidentiality rights.
Patients, healthcare professionals and the public have the right to access clinical research information that may affect patients’ and public health, new and existing treatments of health conditions and access to innovative clinical research.
EUCROF released proposals on the early publication of clinical trial information, balancing the public’s need for transparency and innovators’ intellectual property and confidentiality rights.
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 are usually 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, health care professionals and the public and thereby ceases to be commercially confidential:
EUCROF believes that the proposed approach has a number of advantages:
EUCROF is committed to continue working with regulatory bodies and all stakeholders and help implement the EU Clinical Trials Regulation to meet its objectives of stimulating transparent, innovative clinical research in Europe. We are seeking to find a balanced approach which is useful to patients and yet not harmful to European early drug development and innovation, so that 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.
You can read the whole paper here.