Terry Fox Research Institute

Clinical trials Manager Ontario

London Regional Cancer Program, London; Algoma District Cancer Program, Sault Ste Marie; The Ottawa Hospital Cancer Centre, Ottawa; Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston; Juravinski Cancer Centre, Hamilton; R.S. McLaughlin Durham Regional Cancer Centre, Oshawa; Ontario Institute for Cancer Research, Toronto, Ontario, Canada
Corresponding author: Bobbi Smuck, CCRP, Manager, Clinical Research Unit, London Regional Cancer Program, 790 Commissioners Rd East, London, ON, N6A 4L6; e-mail: Bobbi.Smuck@lhsc.on.ca.

Abstract
Purpose: The Ontario Institute for Cancer Research supported the creation of a working group with the objective of developing a standard rating scale to evaluate clinical trial complexity and applying the scale to facilitate workload measurement for Ontario cancer research sites.

Methods: The lack of a mechanism to measure the workload involved in a clinical trials protocol was identified and confirmed by a literature review. To collect information on how Ontario sites were assessing workload, a survey was distributed and evaluated. As a result, the working group developed the Ontario Protocol Assessment Level (OPAL), a protocol complexity rating scale designed to capture the workload involved in a clinical trial. After a training workshop on the application, OPAL was evaluated by 17 Ontario cancer centers to demonstrate its reliability and consistency during a 3-month pilot study.

Results: Twenty-seven protocols were reviewed by multiple sites, and the majority of the sites reported OPAL score differences between 0 and 1.5.

Conclusion: OPAL provides clinical trials departments with an objective method of quantifying clinical trials activity on the basis of study protocol complexity. With consistent application of OPAL, sites can manage staffing objectively. The working group is continuing to monitor the application of OPAL in Ontario.

Ontario Protocol Assessment Level: Clinical Trial Complexity Rating Tool for Workload Planning in Oncology Clinical Trials — JOP

BMC Medical Research Methodology at the 35th Annual Conference of the ..  — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.

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