Frustrated by Regulations?

Please help us streamline clinical trials in Canada by completing the survey here: https://www.surveymonkey.com/r/ISCTGuidelines

If you are unable to access survey monkey, you can download the survey as a pdf file here.  Please send completed copies to kate.darling@n2canada.ca

Completing this 10-question survey will inform future directions of the Initiative to Streamline Clinical Trials (ISCT) Working Group, and provide information to be presented in discussions with Health Canada. We appreciate your support in taking a minute to complete the survey. Even if you are unfamiliar with the ISCT guidelines or have not implemented them, your responses will help shape future work on this initiative. The survey is anonymous and results will be aggregated. Click the button below to start the survey.

Background
In 2011, the Canadian Cancer Research Alliance (CCRA) report on the State of Cancer Clinical Trials In Canada identified 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”. One of the recommendations in 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.

In response, the Initiative to Streamline Clinical Trials (ISCT) Working Group was organized in 2012, and included members who are experts in clinical trial conduct across many therapeutic areas. The primary objective of the ISCT was to develop specific, pragmatic, and practical interpretations of current regulations, laws and guidelines, in order to facilitate, rather than limit, Canadian clinical trials, by expanding on recommendations such as those of the CCRA and OECD. The guidelines were finalized in February 2014 and are available at http://n2canada.ca/isct/.

Since the 2011 CCRA report, the ISCT Guidelines has been one of many initiatives underway nationally to address threats to the clinical trial enterprise. While results are promising, understanding of the current environment as well as the implementation and impact of the ISCT Guidelines by academic Investigators, Institutions, and Sponsors is needed to determine future actions required.