Will Canada’s Multi-Center Approval Processes Help Your Oncology Clinical Trial Exceed Pivotal Milestones?
For the Sponsor choosing Canada to help meet and exceed pivotal corporate objectives on their…
Now more than ever, time is of the essence when it comes to oncology clinical trial start-up and execution. The advent of cancer immunotherapy, considered by Science editors to be 2013’s Breakthrough of the Year¹ and the American Society of Clinical Oncology (ASCO)’s Advance of the Year in 2016 and 2017 resulted in thousands of new studies coming to the clinic. In this competitive space, it becomes increasingly important to start (and finish) trials quickly in order to analyze study endpoints and make “go or no go” decisions.
One strategy which can be crucial to an expedited study start-up and enrollment is the use of a centralized research ethics board (REB) such as the Ontario Cancer Research Ethics Board (OCREB).
Established in 2004, OCREB is an offshoot of the Ontario Institute for Cancer Research (OICR) and is accountable to their Board of Directors through its Governance Committee. As of June 2018, OCREB has over 30 participating hospital centres engaged in research reviewed by the board.² OCREB is comprised of oncology experts including medical, surgical and radiation oncologists and hematologists, research nurses, statisticians, ethicists, study coordinators, pharmacists, lawyers and community representatives.
Broadly, OCREB’s overarching mechanism is to designate one Ontario centre as the “provincial applicant” responsible for submission of a study. Once the trial has been approved, the other participating centres receive OCREB approval within days.³ In February 2017, OICR entered into a participation agreement with Clinical Trials Ontario (CTO). With this new partnership, applications for OCREB review are submitted in CTO “Stream”, which is a secure, web-based system developed and administered by CTO for province-wide health research submissions.³ Below is a schematic which illustrates the OCREB application process:
Employing OCREB reduces the time and expense that would be associated with having a separate research ethics review at each participating study site. From a feasibility perspective, OCREB will accept a study for review with only one confirmed participating centre so long as the sponsor is confident that additional sites will be selected and agree to participate. For study sponsors and CRO partners, OCREB reduces the burden of reviewing and approving site specific informed consent forms (ICFs). Each participating centre is required to use the approved provincial ICF with administrative changes only (for example, site-specific letterhead, contact information, etc.)
Once the trial is active, the provincial applicant retains the responsibility for study-wide submissions (protocol amendments, consent form revisions, reports from the data safety monitoring board, etc.) further reducing duplicate work for participating sites and sponsors. For early phase trials, this means that in circumstances where enrollment must be put on hold while the protocol is revised with respect to dosing or new safety information, interruptions will be minimized and sites can be re-opened to accrual faster.
From an enrollment perspective, Ontario is the most densely populated province in Canada with several cancer centers concentrated close to the US border. Trials reviewed by OCREB routinely have upwards of 5 participating centers in Ontario². Sites such as the Princess Margaret Cancer Centre in Toronto, Ontario report that 1 in 6 of their patients participate in a clinical trial. An effective strategy in Ontario is often critical to the overall outcome of the trial in Canada and perhaps even North America.
Engaging with a CRO partner with OCREB experience means that the efficiencies of this framework can be fully exploited in order to drive the success of the trial in Canada both from a start-up and enrollment perspective.
Contributed by: Leigh Miller, BScH, CCRP, PMP, Clinical Trial Leader