International Clinical Trials Day (ICTD) 2016
ECRIN held a meeting on "Clinical trials in the era of personalised medicine" on May 20th, 2016 in honour of International Clinical Trials Day (ICTD).
The event, which brought together around 150 participants, was organised in collaboration with ECRIN's Czech national scientific partner (CZECRIN), and held at the Senate of the Parliament in Prague, Czech Republic.
The ICTD conference first addressed the unclear definition of personalised medicine, a phrase used in three distinct situations: individualised medicine, targeted therapy and stratified medicine.
The personalised medicine approach refers to healthcare strategies where the treatment option depends on decision trees involving identification of genomic biomarkers, epigenetic factors, phenotypic characteristics, and psychological, social and environmental determinants. Personalised medicine however appears as a quantitative rather than qualitative change in medical practice: treatment decision is based on a more complex and comprehensive diagnostic procedure, more closely related to the molecular and cellular mechanisms underpinning the disease.
Such increased complexity is expected to result in improved accuracy of treatment, enhancing safety and/or efficacy. However, targeting a protein or signaling pathway may not necessarily lead to the expected therapeutic action. Treatments still have to be tested in interventional trials to demonstrate their superiority in terms of efficacy and safety when compared to the standard of care. This raises many issues regarding the sample size, multiple analyses and trial design.
Access to patients and to medical expertise is anyway critical to provide evidence for the efficacy and safety such healthcare strategies. Therefore, international cooperation, and access to multinational funding sources is crucial for the development of this therapeutic approach.
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