Canadian Case Studies
CANADA CANCER CLINICAL TRIALS NETWORK
Launched in June 2013, the Canadian Cancer Clinical Trials Network (3CTN) is a pan-Canadian network designed to strengthen academic-sponsored cancer clinical trials capacity and to improve patient outcomes. 3CTN's central coordinating hub and secretariat for a clinical trial cancer network with sites across Canada is located at the OICR facilities. The Ontario Institute for Cancer Research (OICR) is the legal entity behind 3CTN and provides administrative oversight for the program.
A formal expression of interest among all Canadian cancer centres (each a “Cancer Centre” or “CC”) revealed demand for a clinical trial management system (CTMS) to manage the clinical trial projects and track clinical trial activities, staffing, milestones, metrics, and finances in an organized fashion in one central location.
After consultation with a wide variety and number of stakeholders, and following the recommendation of a working group of 3CTN stakeholders, the EDGE Clinical Research Management System (EDGE) was selected by 3CTN as a preferred system and used as a common platform for all member sites and the 3CTN Coordinating Centre.
In Sept 2011, the clinical trials department of Hamilton Juravinski Cancer Centre (JCC) adopted and piloted EDGE with great success. Based on the positive impact in the U.K. and JCC, 3CTN aims to offer the EDGE system across Canada, so that interested Canadian research sites may benefit.
The focus of year one 3CTN activities was to set up EDGE centrally and initiate a pilot at the Ottawa and British Columbia Cancer Agency (BCCA) sites. EDGE adoption is supported by 3CTN-funded “EDGE super users” who across the Network assist with implementation and to ensure sites use EDGE effectively. These super users are situated throughout the Network, and ensure EDGE is leveraged to track recruitment and efficiency data at the site level. They are playing an instrumental role in collaboration with the Coordinating Centre to promote best practices and to determine how EDGE can best be used to benefit all sites across Canada.
In year two, the 3CTN pilot sites (Ottawa and BCCA) demonstrated positive results. Meanwhile, other centre representatives attended EDGE administrative training in June 2016 and have started planning the implementation of EDGE at their respective sites.
With multiple EDGE demo sessions held in year one and two, the interest and demand for EDGE across Canada has been overwhelming.
Year three has seen great progress in implementation of the software locally at network sites.
The EDGE system is helping to improve cancer clinical trials across Canada by improving the ability of sites to analyse and use trial data to their advantage. 3CTN believes the Canadian cancer clinical trial infrastructure will be greatly improved by the implementation of EDGE, which will result in more efficient clinical trial teams across the Network.
3CTN is pleased to share feedback from the Coordinating Centre and some site stakeholders:.
FEEDBACK FROM THE 3CTN COORDINATING CENTRE
The implementation of EDGE as the CTMS for Portfolio management has allowed 3CTN to collect and track metrics for a Portfolio of priority academic cancer clinical trials (ACCT) since 2011. This data will allow 3CTN to demonstrate impact and trends in the ACCT environment in future years (i.e., trial complexity, personalized medicine trials, patient recruitment, and site efficiency).
The potential impact is immense, as EDGE hosts a comprehensive listing of the 3CTN portfolio trials across the Network, and thus facilitates increasing access to academic clinical trials for patients searching for a trial, or for researchers seeking opportunities for their patients to enroll in a trial. This may be beneficial to the screening and recruitment process and thus could assist with increasing patient recruitment overall.
Accrual is the key metric emphasized by the 3CTN since its launch. It is the most downstream and tangible of 3CTN’s deliverables. EDGE allows for efficient data management (1) at the coordinating centre level to extract the recruitment and site efficiency metrics as a reporting portal, and (2) at the site level by facilitating tracking of patient screening and recruitment. Furthermore, EDGE has the capacity to reduce burden for recruitment data reporting by sites. The sites that adopted EDGE no longer need to submit excel files to the Coordinating Centre. The success with EDGE would go a great distance towards making 3CTN’s metrics reliable and thus allowing accurate and real-time monitoring.
FEEDBACK FROM JURAVINSKI CANCER CENTRE
The Hamilton Health Sciences Juravinski Cancer Centre (JCC) is one of Ontario’s Network Cancer Centres. JCC adopted EDGE in 2011 as the first Canadian pilot site, and developed a unique collaboration with the EDGE United Kingdom (UK) group at the University of Southampton to make the system more applicable to Canadian environment.
The success of leveraging EDGE into their clinical trials management has led to many inquiries from other cancer research institutes, and EDGE as the ultimate selection by the 3CTN Coordinating Centre as a preferred common platform for its network sites.
JCC has accumulated more than ten years of clinical trials recruitment data, developed many best practice guidelines, and continually extracts information from the system for data analysis. They are moving forward with implementing EDGE as the electronic regulatory “binder;” expanding the use of EDGE for finances, workload tracking, and training; and engaging investigators in using the system.
Although JCC is still connecting with the EDGE UK instance and data migration requires careful appraisal of the pros and cons of each version, they actively participate in the Canadian working group and other 3CTN member sites to share their experiences and input in the efforts towards having one unified Canadian EDGE system.
FEEDBACK FROM THE OTTAWA HOSPITAL CANCER CENTRE
The Ottawa Hospital Cancer Centre (TOHCC) is one of the Ontario’s Network Cancer Centres (NCC) dedicated to shaping the future of cancer trials by implementing the powerful EDGE Clinical Trial Management System (CTMS).
EDGE went live on January 5, 2016 at TOHCC and the project was initiated by entering trial information for site groups starting with head and neck, central nervous system, melanoma, sarcoma, and gynaecology. Subsequently genito-urinary, Phase I, lung, gastrointestinal and breast data was entered. To date, TOHCC has been able to enter five years of historical data for each group.
Having five years of legacy data in the new database system has proven invaluable for the cancer centre in Ottawa. They are excited to use EDGE as a powerful reporting tool to follow trends in research including, but not limited to, how much of an impact clinical trials have on the chemotherapy department and the pharmacy, or determining if studies are trending towards more oral or intravenous drugs. They can follow the impact of today’s trials on the workload of staff as study designs have changed from simpler designs in broader patient populations to more complex interventions in more targeted populations (e.g., molecularly targeted drug therapies). Prospectively, the system is also able to help answer these questions by capturing the workload of staff in real time. This information has been used to ensure that staff members are assigned appropriate workloads, which helps to ensure productivity is optimized. They believe using the complete data set will help shape clinical trials management at TOHCC for years to come.
FEEDBACK FROM BRITISH COLUMBIA CANCER AGENCY (BCCA)
The BCCA is excited about EDGE’s ability to connect all six of its regional cancer centres to improve collaboration and efficiency. EDGE is used to track all of BCCA’s studies.
“The potential value of EDGE for our province is huge,” says Bernie Eigl, Provincial Medical Director, and Clinical Trials at the BCCA. “EDGE can do so much, from the capabilities of tracking metrics on individual trials to creating tailored reports for our different stakeholders such as our funders, investigators, foundations and the public.”
Apart from the benefits associated with tracing Canadian trial patients, and researchers having improved access to academic trials, there is a distinct potential that this increased efficiency at the site level will, in turn, increase patient recruitment across the Network. Dr. Eigl explains that EDGE could impact access to clinical trials for all BC cancer patients. “Every centre in the province will go into the same system and be able to see which trials are available at each centre. Then a decision can be made to cross-refer patients or even open that trial at a second site. For example, if a trial is open at Vancouver, patients could be referred to Vancouver for the trial or if there is a large enough population in, say, Kelowna, they can activate the trial there. This ability to coordinate and cross-refer patients, if required, is the one key feature we have been missing in the past.”
FEEDBACK FROM LONDON HEALTH SCIENCES CENTRE: A CASE STUDY ON HOW YOU USE EDGE AND WHAT BENEFITS IT BRINGS TO YOUR ORGANIZATIONS.
EDGE was implementing on August 15th 2016 by the CCRU (Cancer Clinical Research Unit) of the LHSC (London Health Sciences Centre), London, Ontario, Canada.
Prior to the implementation of EDGE the London group had numerous files, EXCEL, ACCESS and WORD 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). During a three month period, June to August, 2016, all the files were uploaded into EDGE including legacy data from January 1, 2012.From a logistics standpoint, having one spot to access all clinical trial information is a huge time saver, and improves patient care as it enables everyone to using the most up to date documents
All members of the patient care team, the Principal Investigators (PI), pharmacy, nursing, coordinators and project management staff are able to see the progress of a trial from delivery of the protocol to the Cancer Clinical Research Unit to trial activation, and also to monitor 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.
One of the unexpected bonuses of using EDGE via 3CTN is the collaboration with other researchers from across the country. 3CTN members learn from each other.
Other members of the academic community in London are looking at EDGE to determine if they wish to use EDGE in the future. This would be very exciting.
EDGE has led to better communication and collaboration which in turn aids the staff in London in being able to better help its patients now and in the future.
London and 3CTN are looking forward to expanding our use of EDGE to improve overall performance.