New treatments and technologies offer valuable benefits, but inevitably carry risks, and regulation is society’s response to this. It makes judgments that seek to balance the potential value and risk: approval, restriction to specific groups of patients or rejection. However, the processes it has developed are too standardized and rigid and insufficiently responsive to the needs of particular diseases, patient groups and treatment situations.
CASMI works on how an “adaptive” approach – shaping the processes and criteria around these factors – can strike a better balance, reduce the costs and time of development and offer patients more affordable treatments more rapidly. We also study the technologies that make this possible, such as new trial designs, new statistical techniques and new ways of collecting and analyzing ‘real world data’ from more routine use.
We ask questions such as: How can we use the new tools of stratified medicine to select and study a new treatment in the right group of patients? How should the patient voice be heard in regulation? What are the ethical issues that arise when treatments are approved earlier and with less evidence? How should the public be engaged? How can we better formal clinical trials and routine outcome data to build a steadily more accurate picture of a treatment over time?
Our objective is to inform and shape the evolution of regulation to get the right treatment to the right patients as rapidly, affordably and safely as possible. We have already contributed to the field in the regulation of stratified medicine, the development of Good Genomic Practice and the design of adaptive development.