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Philip Ward is ACT's European editor, phone +44 1244 538583, firstname.lastname@example.org
EUCROF has unveiled proposals on the early publication of clinical trial information.
The European Contract Research Organization Federation (EUCROF) has unveiled proposals on the early publication of clinical trial information. They aim to balance the public’s need for transparency and innovators’ intellectual property and confidentiality rights.
Patients and healthy volunteers who participate in early phase studies are usually not expected to gain any health benefit. To provide a transparent approach of public access to early clinical research information, the authors of the EUCROF statement propose releasing the information as and when it becomes relevant for patients, health care professionals and the public and thereby ceases to be commercially confidential.
Their three key points are: relevant registration information should be made publicly accessible via the EU 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) should be clearly defined and justified in each clinical study protocol and approved via the clinical trial authorization; and in the case of any changes to the authorized publication process and timelines, a substantial modification must be submitted and, if justified, authorized prior to implementation.
The authors believe their approach has several advantages:
For the full position paper, click here.
Read the full release here.