Nick Latimer was invited to give a talk at the FDA/AACR Immuno-oncology Drug Development Workshop held in Washington, DC in October. The aim of the workshop was to develop a path forward for evaluating an immuno-oncology-focused nonclinical and clinical development paradigm, including a re-definition of biological outcome measures and clinical endpoints, leading to innovative clinical trial designs and statistical methods in the development of immuno-oncology clinical trials.
There were some extremely interesting talks on outcome definitions, with the FDAs own research leading the way in addressing issues with the definition of disease progression. Nick gave a talk on methods for analysing survival data in the absence of proportional hazards - something which is not uncommon in technology appraisals undertaken in the UK. Transcripts and slides from the workshop are available
here.
