Study designs for clinical trials applied to personalised medicine

In July, PERMIT WP6 hosted two working sessions mainly focused on three specific trial designs commonly used in the field of personalised medicine (platform, umbrella and basket design). Experts in the field discussed how these three complex trial designs can be used for the development of personalised medicine, their advantages and their disadvantages. The working sessions also focused on the methods for comparative effectiveness and cost-effectiveness of personalised medicine versus non-personalised medicine strategy. The first virtual working session was hosted on July 2nd and gathered together 14 regulators, HTA and industry representatives. The second one on July 6th brought together 13 investigators and academics with methodological and statistical expertise in clinical trials and personalised medicine.  The outcome of these meetings will be used for drafting the first version of recommendations on complex trial designs and methods for comparative effectiveness and cost-effectiveness of personalised medicine vs. non-personalised medicine strategy.  The final recommendations will then be validated and discussed in a dedicated workshop with a larger group of experts scheduled for Fall 2021.