Initiative to Streamline Clinical Trials (ISCT): Guidance for Investigators/Sponsors

The 2011 Canadian Cancer Research Alliance (CCRA) report on the State of Cancer Clinical Trials In Canada outlines in detail the magnitude of the threat to the conduct of oncology clinical trials. The Report noted that with falling performance metrics, increasing complexity and workload, and an increasingly onerous regulatory environment, clinical trials were at risk, and observed that “Without clinical trials, the outcomes of cancer patients will not continue to improve”. The report recommended engaging with Health Canada and other key stakeholders to foster agreement in appropriate interpretations of the Health Canada Food and Drug Regulations and ICH Good Clinical Practice (GCP) guidelines.