Successful clinical trials management for the 3CTN Coordinating Centre (CC) and for 3CTN sites requires a flexible system to track trial-related activities. The system has to work well at two levels: for the CC and the sites. The CC needs to have a system to support the identification and communication of portfolio trials to patients and the public. Also, such a system is important for the evaluation of 3CTN against its milestones and deliverables laid out in its business plan. In addition, to demonstrate an increase in recruitment to academic clinical trials in Canada. 3CTN required each participating site to establish an accurate baseline for recruitment. This is used to continuously evaluate the performance and impact of the Network. A flexible system facilitates this evaluation. Among all Canadian cancer centres responding to the initial 3CTN expression of interest, there was a demand for a clinical trial management system (CTMS) to manage the clinical trial projects, track clinical trial activities, staffing, milestones, metrics and finances centrally and in an organized fashion. The optimal solution to track the metrics and research activities is a common platform for all member sites and the 3CTN Coordinating Centre.
3CTN went looking for a CTMS solution. After consultation with a wide variety and number of stakeholders, and following the recommendation of a working group, based on the positive impact in the UK and first Canadian site (i.e. Juravinski Cancer Centre), the EDGE Clinical Research Management System (EDGE) was selected by 3CTN as the preferred system to roll out at the CC and Canadian cancer centres that expressed interest.
The EDGE system, which was developed in the U.K by the University of Southampton and University Hospitals Southampton National Health Service Foundation Trust, was first introduced in 2001. Since then, EDGE has been used by all the U.K. cancer research networks and several other networks established by the Department of Health in the U.K. EDGE provides an innovative cloud-based clinical management system that empowers administrators and investigators to make the most of their research data. EDGE is specifically designed to give a real-time view of clinical research activity within a single hospital or across various research networks.
The CC formally adopted EDGE in September 2014, with the first goal being the tracking of the portfolio. The CC EDGE hosts a comprehensive listing of all 3CTN-endorsed cancer clinical trials. It allows management of the portfolio, including trial application, and timeline tracking of the review and approval process in a clear, efficient and measurable system. In addition to portfolio tracking, the CC can process all data in EDGE and extract the aggregate and site efficiency metrics with ease. It provides a real time and accurate picture of the high impact academic clinical trials across Canada. The national benchmarking data has also proven to be useful to facilitate ongoing process improvement.
EDGE provides an efficient way to collect and process the data without imposing an excessive burden to 3CTN sites. This common platform limits duplication of data entry and ensures ease of data transfer between 3CTN member sites and the CC. For sites that had already adopted a different CTMS prior to 3CTN, EDGE provides portal capability and flexibility to take-in data from the various systems used by sites.
Since the adoption of EDGE by 3CTN, the CC has developed comprehensive implementation supports. These supports include: live demonstrations of the system, project planning, training and first line support to facilitate the roll-out to interested cancer centres. Regional super users were hired to assist with implementation and to ensure sites use EDGE effectively. These super users are situated throughout the Network, and collaborate with the CC to promote best practices, and to determine how EDGE can best be used to benefit all sites across the country.
At the site level, most sites using EDGE are tracking recruitment. Many sites are starting to use EDGE to track regulatory processes and finances for their active recruiting trials, as well as legacy data. The EDGE users are especially pleased with the powerful reporting capabilities of EDGE, which allows them to follow trends in research activities over time. Prior to the implementation of EDGE, sites had numerous files, over a number of file directories to keep track of the progress of trial activation, ethics submissions, contract processes, budgets, and trial metrics (screening and accrual reports). From a logistics standpoint, having one place to access all clinical trial information is very efficient, and ultimately improves patient care as it enables everyone to use the most up to date documents and information. All members of the patient care team are able to see the progress of a trial from delivery of the protocol to trial activation, and the screening and accrual of patients. “EDGE provides us with a wealth of knowledge to know which trials are accruing and which are not and why not” states Richard McClelland from London Regional Cancer Centre. Being a network-customized and web-based application, EDGE has led to better communication and collaboration within the cancer clinical trial community, and across the country.
As a result of CC and site level implementation, the EDGE system is helping to improve the conduct of cancer clinical trials across Canada. It enables reliable and real-time measurement of trial metrics and improves the ability of sites and the CC to analyze and use trial data to advantage which should lead to more efficient activity across the Network.
The progress of EDGE Implementation in Canada:
3CTN Coordinating Centre – live
Ottawa Hospital Cancer Centre (TOHCC) - live
British Columbia Cancer Agency (BCCA) – six sites live
London Health Sciences Centre - live
Lakeridge Health - live
Kingston General Hospital Research Institute - live
Any sites who are interested in knowing more about EDGE can contact the Coordinating Centre or live sites for more information
3CTN Recruitment Tools in Action: The Corrective Action Plan
As part of the ongoing effort to provide Network sites with valuable tools for clinical trial recruitment, the 3CTN Coordinating Centre (CC) released the Corrective Action Plan (CAP) Template in November 2016. This tool was developed with the help of a small working group in hopes it would provide sites with a systematic way to analyze and correct local recruitment issues for actively recruiting clinical trials.
Recently, the Windsor Regional Hospital NACC used the 3CTN CAP as a platform to build a local policy around the formal analysis of ongoing clinical trials. Prior to the release of this 3CTN tool, this NACC did not have a formal way to engage local PIs to try and understand why some trials may have recruitment numbers that are lagging behind the expected enrollment. “The CAP tool is allowing us to interact and collaborate with our local Investigators, as we had no official means to address low recruiting trials prior to implementing this policy”, says Krista Naccarato, Clinical Trials Business Coordinator for the Windsor Regional Hospital Cancer Program.
It is well known that trials that are left open at sites with little or no recruitment are a drain on local financial and human resources, as regulatory maintenance and other processes still have to be conducted to ensure trial compliance. Krista acknowledges: “the CAP allows us to discuss the trial with the Investigator, rather than us just informing them we intend to close the trial.” The goal of the CAP is to ensure these local trial staff conversations are fruitful and recruitment pitfalls can be corrected while the trial is still open to recruitment.
The 3CTN CC applauds the Windsor NACC staff for leveraging a 3CTN tool so effectively, and hopes that other sites across the Network will find the CAP tool valuable. In the constant monitoring of recruitment numbers, and opening a formal dialogue with trials staff and local Investigators, the CAP tool may be a powerful way to help sites analyze recruitment issues, and course correct to help boost recruitment while the trials are still open locally.
PPI in Focus: Patient Advisory Group at Cancer Care Manitoba
In the December 3CTN newsletter, CancerCare Manitoba’s new Clinical Trial Focus Group was featured as a valuable, innovative way to engage patients’ ideas, concerns, and wishes in the site’s decision making about how to address any barriers for patients or caregivers, how to increase patient awareness of clinical trials, and how to make the language used in promotional material more appealing and easier to understand for patients. Since December, this group of six patients led by Clinical Trial Recruitment, Specialist Gina Garrett and attended by Clinical Trials Unit Manager, Kathryn Dyck and Senior Research Nurse, Barb Ammeter has had two meetings. These meetings took place on December 8, 2016, and February 2, 2017, with the third meeting planned for April 6, 2017. The Coordinating Centre contacted Kathryn Dyck to share some exciting news about the progress the group has made to date.
Having a management background, and no previous experience from direct contact with the cancer patients, Kathryn was apprehensive about the group’s initial meeting. Her apprehension was related to being unsure how the work of the Clinical Trials Unit was regarded by the patients, and if their emotional state after participating in the clinical trials reflected any frustration with the existing processes. To Kathryn’s delight, her apprehension rapidly diminished by the end of the first meeting, once patients confirmed they were eager to contribute to the advancement of the activities of the Clinical Trials Unit. Realizing that the patients really wanted to be part of this group, and provide their feedback, Kathryn quickly envisioned the potential positive impact the “patient voice” could have on promoting clinical trials. During the first meeting the team assessed the degree of general information the patients had about the clinical trials, and what information they wished they had access to prior to going into their clinical trial treatments. After the patients indicated the clinical trial information included in the package given to all new patients coming to the center was minimal, the group agreed that additional information specific to clinical trials is needed.
The second group meeting was focused on obtaining patient feedback about the promotional materials such as a planned clinical trial poster to be placed in every clinic exam room, an informational pamphlet for new patients, and the clinical trials section of the CancerCare Manitoba website. Participants felt strongly that the “It Starts With Me” video, currently hidden away in the related links section of the website, should be more visible and brought to the forefront. Promotional materials were deemed to benefit from more photos featuring babies and younger children along with older people to emphasize that clinical trials efforts will benefit future generations.
For the third meeting in April, the group is planning to review and provide feedback on the patient displays that are being designed for International Clinical Trials Day in May. “Obtaining quotes from the patients based on their participation in the clinical trials and including ‘good news stories’ is important going forward,” Kathryn says, “because those are the stories that will resonate with other patients considering participation in the clinical trials”. Besides sending thank you letters to the patients at the conclusion of the sessions in April, Kathryn says that showing them the actual changes that were made as a result of their participation in the group will bring tangible and appreciable reward to them.
The 3CTN Coordinating Centre is excited, and looks forward to hearing more about this PPI project at CancerCare Manitoba, and the results of their third planned meeting in April. It is impressive to hear about the successes of a unique approach to PPI like this, and to hear about the way it has allowed rewarding interactions for all of the staff, and patient participants involved.
Title: SABR-5 Full title: Phase II non-randomized Trial of Stereotactic Ablative Radiotherapy (SABR) for Oligometastases Sponsor: BC Cancer Agency NCT#: NCT02933242
Significance: Stereotactic Ablative Radiotherapy (SABR) for up to 5 metastases is increasingly being utilized worldwide, despite the lack of evidence for its utility and relatively non-robust data on the potential toxicity. The primary purpose of this non-randomized phase II trial is treat all SABR oligometastatic patients on a provincial protocol and assess the toxicity and quality of life associated with this relatively novel indication for this treatment. Secondary endpoints include local control, progression free survival, and time to initiation of chemotherapy.
Sites open to recruitment: 6 Additional sites pending: 0 Open to Additional Canadian Sites: Yes Current Number Enrolled: 07 Global Target Recruitment: 200 Study Duration: 2016-2022
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March 1, 2017 – 3CTN Steering Committee Meeting
March 23, 2017 - EDGE Demo
April 3, 2017 – 3CTN Portfolio Committee Meeting
June 22, 2017 – 3CTN SAB Meeting
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