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Clinical Trials 101

Clinical trials are research studies involving people. Because people are involved, all clinical trials must be reviewed by Health Canada and shown to be safe. Clinical trials must also be approved by the Ethics Committees of all participating hospitals. These review processes are in place to protect the safety of participants. Only those studies that pass these rigourous approval processes are allowed to recruit patients. To answer this question, we must firstly define the four phases of clinical trials:

Phase I :  
"What is the best and safest way to administer the new therapy?" A Phase I trial usually involves a small number of volunteers. The testing establishes the optimal dose for the new agent, and perhaps the best way to administer it (e.g. orally or intravenously).
Phase II:  
"Does the new agent work in a selected group of patients?" A Phase II trial typically involves a larger group of volunteers than a Phase I trial. Volunteers are usually chosen to reflect a particular type or stage of the disease. The goal is to evaluate how effective the new therapy is in treating the disease in this type of patient. Possible side effects are also monitored.
Phase III :
Only therapies that are effective, safe and have tolerable side effects can proceed to Phase III testing. Phase III trials compare the "standard of care" to the new treatment and are usually the largest, involving hundreds or even thousands of patients at cancer centres around the world.
Phase IV :
A Phase IV trial is sometimes referred to as "post marketing research". It is research on a drug that has already been approved and is being used widely.
Phase Number of Participants Goals

I

15-30 patients
  • To find a safe dosage
  • To decide how the agent should be given
  • To observe how the agent affects the human body

II

Under 100 patients
  • To determine if the agent or intervention has an effect on a particular cancer
  • To see how the agent or intervention affects the human body
III Generally, from 100 to thousands of people
  • To compare the new agent or intervention (or new use of a treatment) with the current standard
IV Generally, from 100 to thousands of people
  • To further evaluate the long-term safety and effectiveness of a new treatment

Multiple Myeloma Research Network Cinical Trials

The Myeloma Canada Research Network is currently focused on Phase I and Phase II clinical trials with an emphasis on developing trials based on research ideas proposed by members of the network across Canada. For more informtion on active MCRN clinical trials, click here.

To find other clinical trials, please visit the following sites:

www.canadiancancertrials.ca

This is a Canadian website that allows you to search by cancer type (myeloma) and location. It also includes a sign-up option for those interested in receiving alerts about new myeloma trials.

www.clinicaltrials.gov

This website is a service provided by the U.S. National Institute of Health. To find myeloma clinical trials in Canada, click on “Search for Clinical Trials” and type in myeloma Canada.