efining and Managing Protocol Deviation/Violation/Exception
Why Should You Attend:
The introduction of new drugs and the ongoing researches on therapies directed at critical molecular targets have caused several difficulties among Medical Oncologists and as well as among Companies and CRO. More than 80% of drugs for all indications entering clinical development do not get marketing approval, with many failing late in development often in Phase III trials, because of unexpected safety issues or difficulty determining efficacy, including confounded outcomes. A critical point is related to the clinical trial conduction within the sites. For the above mentioned reasons, it is important to know what deviations, violations and exceptions represent and when they could have an impact on the clinical trial results.
Areas Covered in the Seminar:
- Traditional statistical design of clinical trials in Oncology (phases of studies, standard endpoints…)
- Introduction of targeted therapies in the Oncology field and the related different needs (i.e. identification and validation of biomarkers).
- Requirements of the regulatory authorities (FDA, EMEA) and we will focus on the meaning of the terms deviation, violation and exception and their impact on the clinical trials conduction and results.