In this webinar, INC Research/inVentiv Health experts discuss the factors that sponsors must take into account as they design and execute clinical trials in this space, beginning with a review of the immunotherapy landscape.
Unique issues arise with each novel immunotherapy treatment, including the selection of relevant endpoints, inclusion of appropriate patients, and surveillance of immuno-modulated adverse reactions. These new immunotherapies pose further challenges for sponsors in ensuring regulatory approvability and compliance, given that there is a separate and very different regulatory framework for each novel mechanism of action. In both the US and EU, distinct regulations apply to cell-based medicinal products, gene therapy, antibodies, and therapeutic vaccines.
Once scientific and regulatory plans have been determined, planning how many sites or how much time it will take to enroll the required number of patients into a trial of a new immunotherapy is sometimes more art than science because there is comparatively little established past history on which to base patient enrollment projections. Therefore, the feasibility processes of estimating the enrollment rate for newer immunotherapies necessarily involves supplementing evidence with the judgment of a multidisciplinary team of experts.
Clinical trials of cancer immunotherapies are, as a result, quite different from those with other cancer therapeutics; they require special planning and are subject to unique medical, regulatory, and operational considerations.