Points to Consider
Safety monitoring of children with cancer enrolled in clinical studies is an ethical, scientific, and legal imperative. Multiple documents address the protection of people enrolled in investigations and some specifically address the enrollment of children. None, however, are specific for the context of children with cancer and in general society is willing to tolerate risks for cancer therapy and cancer clinical investigations that are not tolerated in other clinical settings.
We would like to get specific advice on:
The limited number of pediatric oncology patients with a given diagnosis make it unlikely that more than one definitive study can be performed in a timely manner. To enhance the interpretation of clinical results, we would like to solicit advice on:
· What types of non-clinical data is considered informative to complement or supplement clinical results
· What the characteristics or properties of non-clinical models and data should be to effectively add to clinical results.
· If no satisfactory models exist, what characteristics should a non-clinical model have to confirm, extend, or substitute for clinical results.
· If there are a set of postulates that can be identified or should be developed