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Clinical Trials
»‘Raising the Bar’ through Clinical Trials
»A Large Patient Population
»Getting Started…
»Clinical Trial Phases
»Major Successes
Getting Started…
Clinical trials involve many people and, more importantly, they involve patient lives and quality of life. For this reason, they are expensive to run, and much time and study goes into both the planning and execution stages.
Participation in a clinical trial is always voluntary, and the Research Ethics Board of the hospital is responsible for thoroughly reviewing the informed consent procedure and the legal forms required to enroll a patient in a trial. All of the known risks associated with participating in a clinical trial are clearly communicated to patients before they can consent.
As a centre operating over 350 trials, PMH has become efficient at the procedure and steps involved in getting a clinical trial launched. It is a very formal process and can easily take more than a year to gain approval.
The first step is to secure the funding for the trial. About one-third of the clinical trials at PMH are funded by private industry (e.g., pharmaceutical companies), a small number are supported by specific grants, and a large number are supported by what is referred to as ‘intergroup studies’. These are studies sponsored by a consortium of organizations including National Cancer Institute (NCI), National Cancer Institute of Canada (NCIC), Radiation Therapy Oncology Group (RTOG), and Ontario Clinical Oncology Group (OCOG).
Many donors to the Princess Margaret Hospital Foundation, particularly those who have been involved in a clinical trial or supported a family member who was, understand the huge importance of clinical trials and request that their donation be channeled to support this area of the hospital. One such donor, Robert Bras, was being treated for gall bladder cancer eight years ago but succumbed to his disease in 2002. Robert was a successful businessman, and decided with his wife Maggie to leave his mark by making a donation to help speed up the slow process of bringing new drugs to needy patients.
Today, the Robert and Maggie Bras and Family New Drug Development Program at The Princess Margaret is a top-tier drug testing facility that is the only non-U.S. site to receive both a phase I grant and a phase II contract from the U.S. National Cancer Institute. In just seven years, it has run 255 clinical trials of new drugs. The program now has the credibility and the international reputation needed to be chosen by pharmaceutical companies and large government agencies for running clinical trials of the most promising new cancer drugs.
Once the funding is secured, the process of applying for a clinical trial begins with the lead investigator developing what is referred to as a ‘protocol’ – which is all the detail on how the clinical trial will run. This includes:
- Purpose – what is being tested and the anticipated outcome
- How the drug or intervention has been tested in laboratory situations
- Number of participants needed
- Type of cancer the participants need to have and their health condition
- Plan for statistical analysis and proposed budget
If the trial is to test a new drug, the protocol details how the drug is to be administered, the recommended dosage levels, and any anticipated side effects.
The protocol must be approved by Health Canada. Once approved the next step is site selection. Locations for the trial must be confirmed and space/staff allocated. Many trials need to be run from multiple locations in order to recruit enough participants for the study.
Once the sites are confirmed, each site undergoes an impact assessment process. Every clinical trial has an impact on existing departments within the hospital (e.g., pharmacy, nursing, medical imaging), and those impacts need to be taken into consideration. While this assessment process is going on, the Research Ethics Board for the hospital reviews the trial to ensure that all privacy and consent issues are being properly managed.
Once all impacted departments and the Research Ethics Board have signed off, the trial is open for recruitment of participants.
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Read about one of the leaders in clinical trials at PMH
View a presentation on Drug Trials by Dr. Lillian Siu
Read about a patient who participated in a clinical trial of a new drug for leukemia
Find out how you can support clinical trials at PMH |
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