The TMF is the official record of the clinical study for Regulatory Authorities, be it…
Given the increased focus on speed of activation for oncology studies, sponsors are under pressure to select top-performing investigative sites that can handle the challenges presented by targeted therapeutics (micro populations, mutational analysis, biomarkers, imaging and high density protocols).
In this interview with Dr. Stephen Welch, Medical Oncologist at the Regional Cancer Center in London Ontario, you’ll find out about some of the changes his center has made to better address not only the increased complexity of oncology trials but also the economic challenges of running clinical trials. He also offers insights into why Canadian sites are so well suited for early phase oncology trials.
Can you tell us a little bit about the London Health Sciences Centre?
The London Health Sciences Centre is comprised of three separate hospitals, all united under one banner to serve patients in the London area. The London Regional Cancer Program is based out of the Victoria Hospital. We’re affiliated with the Schulich School of Medicine at Western University, which is the third largest university campus in the province of Ontario.
We provide cancer care to a fairly large catchment area that comprises about 1.5 million people, as The London Health Sciences Centre is the tertiary care referral centre for all of Southwestern Ontario.
What is the mission of the London Regional Cancer Program?
Our mission is to provide patient centered care, according to evidence based guidelines and standards. Our key strategic directions are to develop leading patient care and service and also to advance research, learning and innovation.
What are the biggest challenges you and other Canadian oncology centres currently face with regards to the increase of targeted therapeutics?
The major challenges not only for Canadian centres, but sites worldwide is the increasing complexity of these clinical trials, with a lot more focus on correlative studies requiring collaboration with various departments within the hospital environment. For example, Departments of Pathology, and Radiology, for sample acquisition, in order to molecularly characterize these patients. We are seeing more and more clinical trials of targeted agents with a very narrow focus that studies only particular subtypes of cancer.
This really requires close collaboration not just between the Department of Oncology or Division of Medical Oncology, but also with our pathology and radiology partners. That’s something that we felt we needed to address at our centre. These types of trials also have greater regulatory requirements, which puts a further drain on research staff.
How are you addressing these challenges?
We’re paying much more attention to the cost of running studies. We recognize the fact that time is money, so we are working very hard at speeding up the activation of studies, as well as addressing studies that have been underperforming and not accruing very well. If we see that happening, then we close them early to reduce the administrative burden. This is something that several sponsors have been really impressed with.
We’ve been able to do this is by changing the format of how our unit is structured and by specializing our clinical research personnel. There was a time when the research coordinators were responsible for everything, including activation of studies, enrolling patients, getting their consent, looking after the data and specimens etc… We’ve now segmented our personnel into specialized sub-units.
We now have activation coordinators whose only job is to take care of all the regulatory requirements that are needed to open the study. We then have patient coordinators who take on a separate nursing role, and we then have individuals who focus more on data collection and data monitoring, and others who are responsible for handling pathology and blood specimens.
The changing face of clinical trials has really changed the way that we operate as a unit. In terms of early phase clinical trials, the group here in London has really understood this and has instituted a number of infrastructure and program changes that I personally have become a part of.
Last year we opened the Gerald C. Baines Centre for Translational Cancer Research, which was designed to be the hub of translational research within the London Regional Cancer Program. We have citywide links to other clinical research facilities, such as the Centre for Clinical Investigations and Therapeutics at the University Hospital, led by a leading clinical pharmacologist named Richard Kim. I am also leading a newly granted cancer drug development program with a mission to lead Phase I and Phase II clinical trials in the London region.
Furthermore, Dr. Eric Winquist leads a translational research team that has worked with the Ontario Institute of Cancer Research to streamline processes that bridge the gaps between oncology, pathology and radiology within our region.
How important would you say initiatives like the Reverse Feasibility Program are in helping to attract early phase oncology trials to Canada?
The main advantage I see to this is that it increases the visibility of our program to drug developers. We see a clear need to give patients in our catchment area access to early phase clinical trials and our academic oncologists the opportunity to conduct these studies. The Reverse Feasibility approach provides an opportunity for us to link up with drug developers in the United States who are in need of sites with an expertise in early phase clinical trials, like ourselves.
Why should US oncology drug developers care about conducting oncology trials in Canada?
Our patient population is fairly similar to the US market, and I’m seeing that regulators and payers actually do care about where trials are being conducted when evaluating these drugs for approval. When compared to other regions, Canada has a long history of good data quality. We also have a universal healthcare system so there’s a consistent pattern of practice across the country, which is a fairly unique situation.
There are also several distinguished Canadian oncologists like Elizabeth Eisenhower, Malcolm Moore, and a new generation of investigators who have learned from them, and like me are really at the forefront of clinical trials internationally. So there are a lot of good reasons to come to Canada to conduct oncology studies.
When should sponsors be thinking of including Canada in their clinical trial plans?
They should think of Canada early on. Including our own centre, there are 10 tertiary care centres in Canada that have the experience and capacity for conducting Phase I studies. Canadian centres also have a strong history of collaboration in Phase II and Phase III studies through our Cancer InterGroup, the National Cancer Institute of Canada Clinical Trials Group.
The Princess Margaret Hospital in Toronto leads a Phase II consortium of many of those centres across the country, that have worked together over the last ten years on Phase I and Phase II studies. That Phase II consortium represents the only National Cancer Institute US sponsored consortium for Phase II studies that is outside of the United States. Finally, our accruals to that consortium are very comparable to what American consortia are able to accomplish and London is one of the leading contributors to that Phase II consortium.
To find out more about the Reverse Feasibility Program, please visit Reverse Feasibility Program. I also invite you to subscribe to this blog to be notified whenever new posts are added. You can also follow me on Twitter at @scimegaresearch. You can also learn more about the London Regional Cancer Program at www.lhsc.on.ca/About_Us/LRCP.