For our final Power in Pink Breast Cancer Awareness blog series, we are excited to hear about the world of Clinical Trials and efforts in pushing forward new, more viable therapeutic options.
Today we turn our attention to Dr. Philippe Bedard, an oncologist at Princess Margaret Hospital who leads a number of clinical trials. His oncology background and extensive work in clinical trials can help shed light on the road blocks affecting progress and current avenues cancer researchers are taking to develop more effective treatments.
How did you get into this field and for how many years have you been active?
PB: I finished my medical oncology residency training in 2008 and then completed a 2-year breast cancer research fellowship at the Breast International Group in Brussels, Belgium. I’ve been on staff at the Princess Margaret Cancer Centre since January 2010. I became interested in medical oncology as a specialty as a first year medical student when I was involved in a clinical research project at Princess Margaret with Dr. Ian Tannock. I enjoyed the interactions with patients and their families as a medical oncologist, the treatment of multi-system disease, and the integration of research and new drug development with clinical care.
Why do drug development/clinical trials take so long and why are new therapies usually very expensive?
PB: It is very difficult to complete the pre-clinical testing, toxicology, and manufacturing for a new drug to enter clinical testing. Once a new cancer drug is ready for clinical testing, there is a very rigorous process that is time consuming and expensive – new cancer drugs must pass through phase I clinical trials aimed at safety and establishing the maximum tolerated dose for future studies; phase II clinical trials that evaluate anti-cancer activity in a well-defined patient population; and phase III clinical trials that evaluate patient response to a new cancer treatment versus the existing standard of care.
What obstacles do you encounter in clinical trials – for example recruitment and patient eligibility?
PB: Clinical trials are increasingly complex. Getting a trial up and running takes a lot of time – negotiating a clinical trial agreement with the study sponsor, applying for Health Canada and Institutional Research Ethics Board approval, and asking for other departments involved in clinical research to agree to participate. Once a clinical trial is active, it can be challenging to identify patients who are interested and eligible for a trial. There are often many visits as part of the trial that may include blood sampling for drug levels and safety monitoring, tumor biopsies for research, and functional imaging for research. Patients treated with new drugs can develop unusual side effects – these adverse events have to be managed promptly and reported to the study sponsor. It can also be very labor intensive to review safety reports from other clinical trials sites and submit these to our Research Ethics Board that oversees clinical research.
What areas of research hold promise for women’s health in the context of drug development?
PB: There is a lot excitement for new drugs that target the immune system. The range of cancers that may benefit from these types of therapies is growing rapidly and there is hope that new drug combinations may be effective in cancers that do not show signs of a host immune response before treatment1.
You are currently leading a number of interesting trials. Based on your ongoing work, what type of new drugs or screening techniques would improve treatment or survival rates of women with breast cancer?
PB: Recent data indicates that the benefit of screening mammography is modest for women at average risk. The challenge is that breast cancer is a very heterogeneous disease and survival from the most lethal types of breast cancer may not be greatly influenced by screening mammography. The greatest gains in terms of breast cancer survival have been realized in HER2-positive breast cancer2. These account for about one sixth of new breast cancer diagnoses. There are a variety of new drugs that target the HER2 receptor that have had a major impact in reducing mortality for early stage disease and increasing longevity for patients with metastatic HER2-positive breast cancer.
What are some common misconceptions about drug development/clinical trials that you have encountered?
PB: I occasionally encounter patients who are worried about being “guinea pigs” as part of a clinical trial and who are reluctant to participate in placebo controlled studies. But awareness of clinical trials is improving in the general public – clinical trials are an integral part of clinical care and provide an opportunity for patients to access promising new cancer therapies. Patients often receive excellent care in clinical trials, with more frequent monitoring and closer communication with their research nurse and other members of the clinical team.
We would like to thank Dr. Bedard for an in depth look at the process and challenges involved in developing an effective clinical trial.
References:
- Immunotherapy is a new avenue for therapy cancer researchers are exploring. The idea is to enhance the body’s natural defenses to fight off cancer cells.
- HER2-positive breast cancer is a subtype of breast cancer that affects approximately 12-15% of women diagnosed. HER2 is a hormone receptor that is sometimes present in excess in a subset of breast tumors and is linked to a more aggressive form of the disease.
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