Clinical Trials

What are clinical trials?

A clinical trial is a research study involving patient volunteers aimed at answering specific arthritis treatment questions. Trials are conducted according to a detailed plan (protocol) that meet research standards set out by Health Canada. The protocol outlines the reasoning for the study, the outcomes being evaluated (like number of stiff or swollen joints), which patients are eligible to participate, the schedules of tests and procedures, the medication(s) being tested (including the dosages and timing), study duration and how the results will be analyzed.

Clinical trials are conducted to find out:
  • Whether a new medication or device is safe and effective;
  • How a new medication compares to existing treatments and medications;
  • Which medication is more effective for a particular patient or group of patients;
  • Alternative ways to use an approved treatment to increase its effectiveness, ease of use, and/or decrease its side effects;
  • How a new medication or approved treatment affects different, previously untested populations, such as children.

Should you participate in a clinical trial?

Patients are encouraged to speak to their rheumatologist about clinical trials before their current treatment stops working. Together, patients and researchers can build a streamlined and effective trials environment. As with most treatment therapies, clinical trials have their own benefits and risks.

Below is a table of what to consider before participating in a clinical trial.

Exclusive access to experimental therapies for free, which is useful if you are unresponsive to current therapies. Your arthritis may not improve and you may experience side effects from the medication under study.
Expert medical care and attention beyond that given by your own healthcare team. Some clinical trials are time consuming and require you to undergo complex medical tests, such as blood tests.
Close monitoring of benefits and side effects can help you detect other health issues. If the clinical trial is a single or double-blinded randomized trial, you may not receive the experimental therapy.
You will feel satisfaction knowing you contributed to improving the health of future generations. You may be required to adjust your lifestyle for the study, such as changing your diet or routine.

What questions should you ask your doctor before you sign up for a clinical trial?

  1. What is the main purpose of the study?
  2. Does the study involve a placebo, new, or current treatment?
  3. How will the treatment be administered?
  4. How does the treatment work?
  5. How long is the study?
  6. What do I have to do?
  7. Are there any published study results regarding this treatment?
  8. What does it cost me to participate? Will my insurance cover these costs?
  9. Will I be reimbursed for my travel expenses?
  10. Will I be able to visit my own doctor?
  11. Can I keep using the medication after the study? How much will this cost?
  12. Can anyone find out if I am participating in the study?
  13. Will I receive follow-up care upon completion of the study?
  14. What will happen to my medical care if I stop participating in the study?
  15. Do the collaborators have any financial or special interest in the clinical study?
  16. Are researchers and their staff trained and experienced in clinical research?
  17. Are there any other tests involved?
  18. How many people are recruited?
  19. Who are the sponsors?
  20. How do you monitor participants?
  21. Would you participate in the study?
  22. What are the risks and benefits to me?