EUCROF Releases Position Paper on Research Transparency

November 4, 2014
Philip Ward

Philip Ward is ACT's European editor, phone +44 1244 538583, philipward1@btconnect.com

Applied Clinical Trials

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:

  • 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, and competent authorities can 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 that operates in compliance with the clinical trial regulation and its objectives.
  • Commercially confidential information is respected.

For the full position paper, click here.

Read the full release here.

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