gms | German Medical Science

Recruitment of patients in early phase clinical trials in oncology benefits from a large, stable, catchment population. Successful early phase clinical trials are based on close integration with the tumour site teams and multidisciplinary teams who provide treatment service. This enables the most cutting edge science to be used in the trial design. Incorporating adaptive design methodologies into clinical trials can enhance efficiency while maintaining trial integrity. They can also reduce the number of patients on placebo and sub-therapeutic doses. The value of adaptive design lies in continuous learning. Traditional trial design uses a rigid protocol and depends on collecting data and analyzing outcomes at the end of the trial. However, the european guideline on the evaluation of anticancer medicinal product in man mentions an adaptive design only for phase II/III trials as a possibility to increase efficiency of drug development. As an example, today's clinical trials are not designed to test metastasis-preventive compounds [1]. There is a strong need to act already during the drug development process, as early as possible with new concepts.