10 Dec 2020
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Moving Personalised Medicine towards wider acceptance and use will depend largely on a new approach to complex international clinical research involving highly selected patient populations, the collection of human biological material, and the use of large databases for bioinformatics. The classical approach to clinical trials cannot capture the necessary data adequately. Now that subgroups of patients are being identified within a broad disease category via prognostic or predictive biomarkers, these scientific advances in diagnostic refinement and stratification have to be incorporated into the format of clinical trials.
The legal framework in Europe needs adapting, not only to permit easier access to smaller groups of subjects, but also to recognise the validity of results from trials much smaller than the classic randomised approach. And clinical trials adequate methodologies and infrastructures that support large screening platforms are needed to ensure quality of the research and reliability of evidence.
Key changes are:
- Innovative research methodologies and trial designs that are endorsed by regulators and payers
- Improved collaboration between academia and industry
- Greater support to public-private partnerships
- Formalisation of a risk based approach
- Clinical trials rules that simplify and speed trial authorisation, taking account of the new paradigm that personalised medicine introduces
- Harmonized legislation and reduced costs and administrative burdens
- Public funding for high-quality investigator-driven and academic international clinical trials
For more information on the activities of this initiative, please contact Denis Horgan, Executive Director