Masterstudiengang "Drug Regulatory Affairs"


Impact of the new legislative framework within the European Union on non-commercial clinical research and investigator-initiated trials: a cross-European analysis with focus on oncology ***

Dr. Markus Hartmann (Abschlußjahr: 2005)

The issue and transposition of the Clinical Trials Directive 2001/20/EC constitutes a landmark for the clinical research process in Europe. Put into place under the auspices of the European Commissions DG Enterprise, the Directive and its enclosed guidelines set forth a modified framework of rules for pivotal studies conducted by commercial sponsors. Founded on the unifying principles of GCP, the Clinical Trials Directive and the GCP-Directive 2005/28/EC regulate as well the conduct of non-commercial studies.

This master-thesis is aimed to investigate the impact of the European legislative process and its transposition into national legislation on the future conduct of non-commercial clinical studies and IIT. The analysis is focussing on clinical cancer research representing an area of unmet medical need and a major scientific, medical and socioeconomic challenge. Carried out in form of a comparative study, the transposition of the Clinical Trials Directive and the present clinical research environment in eight EU Member States (Germany, UK, France, Spain, Italy, Belgium, Sweden and the Netherlands) is analysed in order to depict a picture of the actual status quo of clinical research in the EU.

At a glance, the easiness for physicians to carry out medical research on human beings has been diminished. Today, sponsor liability issues, the provision of drugs free-of-charge, raising worries regarding insurance conditions, missing structural and educational support to set-up trials and funding problems are named as major hurdles to conduct non-commercial trials. The new framework asks for considerable administrative and regulatory maintenance and requires the implementation of quality assurance systems.

A discrepancy between the goals of the directive (enforcement of patient protection, enhanced drug quality standards for clinical trials, elimination of red-tape, R&D speed-up and transparency) and the results might be stated regarding the set-up of the initial GCP framework in the EU. Nevertheless patient protection is enforced especially in case of non-commercial clinical trials carried out with investigational medicinal products not manufactured GMP-conform in the past. Such GMP or GCP deviations were assumed to occur more frequently in case, manufacturing processes took place at university-based plants or at biotech spin-offs.

Regarding the future regulatory process, the scenario remains unclear. The GCP-Directive now gives Member States more flexibility, to rule investigator-initiated trials able to show enormous public health benefits. Of interest is, if Member States follow the actual SmPC-ruled classification system for IIT (“essential proximity”) or if they develop like in the US a risk-assessment approach offering physicians more choice in patient-focused research.

Pages: 41

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