Design and Conduct of Early Clinical Studies of Immunotherapy: Recommendations from the Task Force on Methodology for the Development of Innovative Cancer Therapies 2019 (MDICT)

the task force on Methodology for the Development of Innovative Cancer Therapies

    Résultats de recherche: Contribution à un journalArticle 'review'Revue par des pairs

    7 Citations (Scopus)

    Résumé

    Purpose: To review key aspects of the design and conduct of early clinical trials (ECT) of immunotherapy agents. Experimental Design: The Methodology for the Development of Innovative Cancer Therapies Task Force 2019 included experts from academia, nonprofit organizations, industry, and regulatory agencies. The review focus was on methodology for ECTs testing immune-oncology therapies (IO) used in combination with other IO or chemotherapy. Results: Although early successes have been seen, the landscape continues to be very dynamic, and there are ongoing concerns regarding the capacity to test all new drugs and combinations in clinical trials. Conclusions: Optimization of drug development methodology is required, taking into account early, late, and lower grade intolerable toxicities, novel response patterns, as well as pharmacodynamic data.

    langue originaleAnglais
    Pages (de - à)2461-2465
    Nombre de pages5
    journalClinical Cancer Research
    Volume26
    Numéro de publication11
    Les DOIs
    étatPublié - 1 juin 2020

    Contient cette citation