Part 3: I gave consent, now what?

Once you have given your consent you will begin the screening procedures.

These may include:

• Physical exams
• Laboratory tests
• CT scans
• X-rays, etc.

If even one of the results obtained from these procedures does not meet the specific criteria identified in your clinical trial you may no longer be eligible to participate. If all criteria are met, however, you can be enrolled.

After you are enrolled you will be randomly assigned to a patient group. We use a computer program ensuring that your group assignment is not affected by anything but a random number generator. Once you are assigned to a group you are officially considered “randomized” in the clinical trial.

The length of time you remain in the clinical trial will vary. Of course our hope is that you will respond to the treatment and have exceptional results but with a clinical trial you must always be open minded. Reasons for removal from a clinical trail include:

• Worsening of the cancer
• Intolerable side effects
• Non-compliance
• Patient’s choice (At any given time during any clinical trial you may choose to go off protocol)

What happens if I am removed/remove myself from a clinical trial?
Your treating physician will find a new treatment that is appropriate for you or may even look for another clinical trial. The research coordinators will continue to collect data from you for your lifetime. This is how survival outcomes and quality of life statistics are gathered. Approximately every two months an auditor visits our research department and reviews all documentation on every study and every patient to ensure that all Federal regulations are being met.

Clinical research trials are not a matter we take lightly. If you ever have questions regarding your participation in a trial talk with your doctor.

You might also like:

• Part 1: Why we belive in research studies
• Part 2: How we enroll patients into clinical trials

Comments

[Clinical]

Being in a clinical trial has literally been a lifesaver for some people. It is a way to get access years before it is available on the market. In oncology, this can be especially important with as aggressive as this disease process is. Also, it is important to future patients who will have access because the clinical trials were conducted and the drug was approved.

[Jeremy Wilkerson]

I agree that that conducting the Clinical Research necessary to improve the care and allow earlier access to people in need.