Canadian Cancer Trials Group Bulletins

Group Administrators Office

Update on the Initiative to Streamline Clinical Trials (ISCT)

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". 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.

The Initiative to Streamline Clinical Trials (ISCT) Working Group, formed in 2012 to address the CCRA recommendations, includes members who are experts in clinical trial conduct across many therapeutic areas. Since 2012, Karen Arts (N2), Jackie Bosch (PHRI), and Lesley Seymour (Canadian Cancer Trials Group) were the co-chairs of ISCT. 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 Organization for Economic Cooperation and Development (OECD). During the discussions, it became apparent that changes to certain regulations or laws interpretations were also desirable.

The focus of ISCT encompassed academic clinical trials of drugs and/or biologics, which are required or interpreted to be required to be conducted under a Clinical Trials Application. Academic trials are defined as trials where the regulatory sponsor of the clinical trial is not a commercial for-profit organization such as a pharmaceutical company or contract research organization (CRO).

The ISCT Recommendations were finalized in February 2014. As indicated at the Canadian Cancer Trials Group Spring Meeting, the Recommendations can now be found on the following webpage - Each recommendation was categorized as being feasible within the current regulatory framework, or if it was felt that changes to existing regulations or laws were required, as recommended.

Next steps for CTG include examining how best to implement the ISCT recommendations to streamline our processes accordingly. This will be reviewed to identify opportunities to reduce complexity. Internally, this has already begun with RIPPLE and specifically considering how to handle delegation of duties.