Monitoring the progress of clinical research is fundamental to obtaining successful outcomes because it ensures…
Those of us who work in clinical operations and oncology drug development can sometimes get caught up in the operations or science and lose sight of the impact our work can have on the lives of people battling cancer. I’d like to share one man’s story to illustrate just how important our work is and why we must continually strive to improve oncology clinical trial performance.
Patient 001-ADC was first diagnosed with Multiple Myeloma back in 2002. As a Registered Pharmacist who had also earned an MBA and worked for a global pharmaceutical company, this man was well aware of his chances for survival and the treatment options that were available to him at the time.
Bleak Outlook for Multiple Myeloma
That’s why when he first met with his oncologist at one of Canada’s top cancer centres, patient 001-ADC expressed his desire to participate in a clinical trial. Those of you who attend the ASCO meetings know about the tremendous progress being made in the treatment landscape for Multiple Myeloma, but back in 2002, there was only one clinical trial available to him in Canada.
Patient 001-ADC eagerly signed onto the randomized trial with a “never give up attitude” only to find out that he had been assigned to the control arm.
It’s stories like these that give true meaning and purpose to what we do and why I am so passionate about our mission here at Scimega, which is to attract cutting-edge oncology trials to Canada and to connect dedicated drug developers with world-renowned and highly motivated oncologists and their patients.
While the treatment paradigm has improved for many indications, we still have a long way to go, as there are still many cancer patients that find themselves, like patient 001-ADC, with limited therapeutic options. Canada is still a region that often gets overlooked by U.S. sponsors who have outsourced the management of their programs to global CROs who lack the necessary relationships to fully leverage Canada’s true potential.
Simply knowing where the investigators are isn’t enough. There are important strategies you (sponsors) need to be aware of if you hope to secure quick start-up and optimal performance out of Canada.
REB (Research Ethics Board) Strategy
Unlike centers in the U.S., Canadian institutions do not have private Central Ethics Boards. Provincial review boards propose that sites identify a “lead” site to coordinate with all other participating sites. Selecting the “right” sites is key, but it’s a complex process so it’s critical to have the right team on the ground to help you navigate the system and expedite start-up.
Site Contract Strategy
Clinical Trial Agreements can be another administrative bottleneck. That’s why you need a Clinical Trial Agreement that is U.S. Biotech friendly, meaning it addresses all of the key issues such as IP, indemnity, ownership and obligations. This alleviates the administrative burden on the sites, thereby speeding up start-up, which leads to faster FSO and first patient-in.
Did you know that the time to prepare a Clinical Trial Application is between one and two weeks when REB and Health Canada reviews are done in parallel? Having the right contacts at Health Canada can also help speed up the process as will knowing when to hold a meeting with Health Canada and when to avoid it.
Update on Patient 001-ADC
You’ll be happy to know that Patient 001-ADC, also known as Mr. Aldo Del Col is alive and well. In 2005, Mr. Del Col co-founded Myeloma Canada, the only non-profit organization uniquely focused on the needs of the Canadian myeloma community.
Their Scientific Advisory Board brings together Canada’s leading myeloma investigators and clinicians and is the foundation of the Myeloma Canada Research Network (MCRN), a study group that activated its first clinical trial early in 2012.
It’s an inspiring story that goes to show you what’s possible when key stakeholders collaborate towards the same goal through programs like the Reverse Feasibility Program. Let’s see how many more success stories we can help come true.
How about you? Do you have any stories to share that illustrate the impact clinical operations are having on patient outcomes? Please share them below or download our Free Quick Reference Guide to Accelerating Site Start-Up by 50%..
Roberto Lara is the Director of Business Development for Scimega Oncology, a Canadian Oncology CRO dedicated to attracting cutting-edge studies to Canada and enhancing overall clinical trial performance. He has over 14 years of clinical trial management experience and is currently completing a specialized MBA in Pharmaceutical Management at l’Université de Laval.