EORTC 26082 – 22081 trial accepted for Voluntary Harmonisation Procedure

The EORTC Brain Tumor and Radiation Oncology Groups 26082 – 22081 trial has been accepted for the pilot phase of the Voluntary Harmonisation Procedure (VHP) for the assessment of multinational Clinical Trial Applications by the European Union Heads of Medicines Agency Clinical Trials Facilitation Group (CTFG). The EORTC is proud to be accepted for this VHP and to test its pilot phase as it runs large multinational clinical trials (MN-CT) in Europe and other countries and views the VHP as a vital step in simplifying and harmonizing the clinical trial application process.

In 2004 the European Union Heads of Medicines Agency established the Clinical Trials Facilitation Group to coordinate implementation of the EU clinical trials directive 2001/20 EC across the member states. It was recognized that in the course of translating the EU Clinical Trials Directive 2001/20/EC into national laws and regulations, divergent practices between the EU member states had emerged. This posed a significant problem for multi-national clinical trials for which applications in different member states might result in different decisions. In order to ensure the protection of participants as well as the scientific value of clinical trials, the CTFG initiated the VHP, a harmonization procedure for the assessment of MN-CT applications.

In practice a VHP is proposed on a voluntary basis by both sponsor and the national competent authorities before the initial phase of the national process. It consists of three phases: a request for a VHP, a review of a draft clinical trial application by the national competent authorities of the participating member states, and, finally, a national step with formal clinical trial applications to each of the concerned national competent authorities. The entire process occurs on a tightly scheduled timeline, an advantage for the EORTC since it will know at once the status of the clinical trial application in all of the foreseen participating countries.

The EORTC 26082 – 22081 trial is designed to document the activity profile of temsirolimus (CCI-779) by evaluating survival rates in patients with newly diagnosed glioblastoma without methylation of the DNA repair enzyme O6-methylguanine-DNA-methyltransferase and who are treated with CCI-779 prior to and concomitant with radiotherapy followed by CCI-779 maintenance therapy. It is planned to conduct this trial in seven EU member states: Belgium, Germany, the Netherlands, Italy, France, Spain, and the United Kingdom. It is also planned to conduct this trial in Switzerland.

In the first phase, the applicant describes the key features of the clinical trial together with the clinical trial protocol synopsis. Within 5 days of the third Thursday of the month, the VHP coordinator informs the applicant of the CTFG decision regarding the acceptance of the clinical trial application in the VHP.

In the second phase, the sponsor is required to submit the VHP application, and this must be done within 15 days of the CFTG notification of acceptance for the VHP. National competent authorities participating in the VHP have 30 days to assess the clinical trial in all its scientific aspects (Investigator’s Brochure, Protocol, and Investigational Medicinal Product related documents) and issue the VHP acceptability statement.

In the third and final phase, national Clinical Trial Applications are required to be submitted no later than 20 days following receipt of the VHP acceptability statement. In the case of the positive VHP statement, national approval should take no longer than 10 days after the submission of a valid application.

In this VHP, the EORTC would like to recognize the collaboration of Wyeth. Wyeth is supporting this study with an educational grant and has provided essential documents for the VHP within very short timelines.

The EORTC is one of the only non-commercial sponsors participating in this VHP for the assessment of multinational clinical trial applications. In fulfilling its mission to develop, conduct, coordinate and stimulate high-quality translational and clinical research aimed at improving the standards of treatment for cancer patients in Europe, the EORTC is constantly faced with multiple national regulations. Driving international clinical trials in Europe is part and parcel of the daily work of the EORTC. As such, the EORTC, a proactive participant in the VHP, warmly welcomes this CTFG initiative.

John Bean

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