The TMF is the official record of the clinical study for Regulatory Authorities, be it…
In this interview Penny Chipman, Manager of the Clinical Research Program at the Gerald Bronfman Centre for Clinical Research in Oncology at McGill University, discusses how clinical research has changed in recent years and what can be done to improve collaboration between sites, sponsors and CROs, with the ultimate goal being to provide patients with greater access to cutting-edge cancer treatments through clinical trials.
She also offers advice to oncology sponsors on things they can do to ensure the successful conduct of their trials. You will hear how Canadian research teams have a lot to offer, not only in terms of quality data and overall efficiency, but the number of highly motivated investigators at sites ideally suited for oncology drug developers looking to expand their clinical trials within North America.
What are the biggest challenges that you and other Canadian oncology centres face with regards to the increased demands for targeted therapeutics?
Many, if not most of the trials now, are requesting mutation testing or archival tissue. The tissue samples must be submitted to central labs, which can take time to receive the results, and as we all know time is of the essence. Furthermore patients on second or more lines of treatment often don’t have much tissue left for analysis. We are starting to see that protocols are asking for fresh tumor biopsies, which patients are often not keen to undergo. Other challenges include overseeing procedures from the operating room, having pathologists available, and shipping the samples immediately onsite. But these are all important because we know that the mutation status is extremely helpful to the physician in terms of proper patient management.
How have these challenges affected the way clinical trials are conducted now versus 10 years ago, for example?
It’s more demanding on the sites now because additional personnel may be needed. It’s basically time, having to wait for the results in order to know how to treat the patient. If the patient does not meet the mutation criteria, the physician or investigator must now rethink how they will treat the patient and time has lapsed. Patients are more anxious. They think their cancer is growing during this time, and just want to start treatment.
From the clinical sites’ perspective, what role does the sponsor and their team play in the successful conduct of a trial?
It all comes down to teamwork. They must work with the site as a team player. Everyone has the same goal at the end of the day, and that’s the well-being of the patient. Sponsors need to understand that not every site works the same way. Knowing their challenges and working out solutions with them can make a big difference. My advice would be to not come to the site and expect them to change their ways to suit you. Listen to what works and what doesn’t work.
How important is it for sponsors to select the right CRO?
It is extremely important for the success of the trial. From a site’s perspective it can be very challenging to work with certain CROs. Sponsors, more specifically the global offices, need to listen to the sites and ask for their feedback. For example, what works in the UK may not work in Canada or the U.S.
It’s also very important for the CRO to send monitors with oncology expertise. If not, study coordinators will become easily frustrated because they are experienced and don’t have the time to train monitors on what they should already know when it comes to an oncology patient. Some CROs don’t understand the Canadian regulations, therefore regulatory documents need to be revised numerous times. Keep in mind that oncology is one of the most difficult therapeutic areas to monitor. There is a lot going on with one patient and everyone involved needs to understand the expectations. Sponsors need to ask the sites before selecting their CRO and listen to their feedback.
How important is it for patients to have more access to novel oncology compounds that they otherwise would not get access to in Canada?
Extremely important. Canadian patients deserve the opportunity to have access to novel oncology compounds. Why should they be excluded? Initiatives like the Reverse Feasibility Program is one of the most important programs working on behalf of Canadian sites and patients. This program allows representatives to go out there and fight for the sites in Canada, to promote Canadian research teams and to demonstrate the need for trials to come to Canada. To be our voice for the sites. I’m a believer and supporter of the Reverse Feasibility approach.What advice can you offer small and mid-sized oncology drug developers?
I would say the input of the Canadian researchers and patients is important for the overall results of their trials. Canadians are true to their word and will recruit the agreed upon number of patients with extremely high quality data. Canadian research teams have a lot to offer, and if sponsors listen to the sites, work with them and understand the do’s and don’ts then start-ups would be smoother and faster. Eventually global offices will see that working with Canadians is easier, and at the end of the day, the data is clean.
I would say push your way into Canada, and make yourself known. Go after the big centres and sell yourself and your drug. There are those of us who will take a chance on the smaller groups because, at the end of the day, from a site’s perspective, they are easier to work with. There have been several small and mid-sized companies that have come to us here at McGill, and we’ve worked really well together and have watched them grow in their development of other drugs. It’s been a pleasure to watch that.
In terms of deciding whether or not to come to Canada, would you suggest that companies come earlier on in their process or only react to it in a rescue scenario?
I would definitely say come earlier. I highly recommend you come right at the beginning and then that way we can work with the sponsor or the CRO to encourage the success of the trial rather than just being the rescuers of a study.
We’re seeing more and more clinical trials being designed in a phase I/II strategy where they’re looking at sites to join in at the expansion of the first portion of the program. How does that fit in with Canada’s needs?Oh definitely. I think that if they’re coming in with that type of a scenario, they’ll have even greater buy-in from the sites in Canada.
To find out more about the Reverse Feasibility Program, please click here. 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. To learn more about the Centre for Clinical Research in Oncology at McGill University in Montreal please click here.