The monitoring burden per patient in oncology trials greatly exceeds that in many other indications. There is a large complex set of factors that are collected related to the patients cancer and prior therapies. However, one of the greatest hurdles is the collection of the adverse event data which is much more voluminous per patient than most other indications. Also, many studies have rather restrictive enrollment criteria that requires more sites with less patients per site. The sites therefore each have a smaller number of patients on the individual study being monitored and often require significant attention to maintain high quality data capture. Strong relationships with the site staff and well-developed monitoring processes can help handle this burden.

Adaptive design is become more frequently utilized in oncology trials and appears to have acceptance by regulatory agencies. If a drug enters later stage trials without an ability to accurately predict what the response in the study may be, adaptive design offers the advantage of permitting the number of enrolled patients to be less if a higher than anticipated response rate occurs.