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A clinical trial is a stepped process by which new methods can be found for safe and more effective diagnosing, treating, managing and preventing cancer using human beings. It can involve new anti-cancer drugs, new chemotherapy, hormonal, biological and immunotherapy agents. A clinical trial can also be testing new methods of surgery, radiation or complimentary and alternative therapies.
The steps, known as phases, are used to describe what sort of study is being conducted and outlines the specific goals of that particular phase. These investigational trials are a necessary step in the process of making a new drug/method/procedure available to the public. Participating in a clinical trial may be your contribution to the advancement of medical science and have the potential of receiving an effective treatment.
There are very strict criteria to meet in order to participate in a clinical trial. Among them are:
Another important consideration for eligibility is the damage that the toxicity of previous rounds of chemo may have caused and what the cumulative effect the new therapy could possibly have on you. A number of trials want the patient to be at least 21 days treatment free so if you are receiving weekly chemo, stopping for 21 days may not be an option. As each trial is unique, it is a question of matching the best possible potential outcome to your present circumstances.
Unfortunately, not all ovarian cancer responds to approved therapies and so your options are limited to either unproven treatments or clinical trials.
The opposite is also true - you may want to participate in order to be on the leading edge of medicine. A trial drug may work differently or possibly better than what you have been receiving - it could prolong your remission. Remember that all existing drug therapies went through this clinical trial stage. What you must also remember is that clinical trials are evaluating their product/therapy using you and that implies risk.
Phase I - is the first step in determining how much of any particular treatment is safe. It is also known as a dose-finding trial, a toxicity trial or a side-effect trial. It is important to realize that this phase is NOT to determine whether or not it shrinks the tumour.
Phase II - asks the question does the drug work and does the cancer respond. Also, does the drug work better with a higher or lower dose? Sometimes Phase I and II are combined to find out more rapidly if the drug should be brought into the front line of therapy. In general, phase II trial patients are all treated with the same study medication.
Phase III - The purpose of this step is to determine whether or not the study treatment is the same, better than or worse than accepted treatments. In this step, different patients with the same disease are treated with different therapies. Patients are randomly assigned one treatment or the other. The patient has agreed to participate and neither they nor their doctor has influence over which treatment they will be given. The treatment used in comparison to the investigative drug would be a standard drug or best known therapy for that stage of the disease. When no standard therapy exists, phase III trials can compare two or more non-standard drugs. Randomized controlled trials are considered the gold standard of investigation.
Phase IV - These trials are carried out AFTER a treatment has been approved. The purpose of these trials is to obtain more information about effectiveness and toxicity as well as to market the drug to the health care professionals.
The following websites list all of the current active clinical trials in Canada and the United States. You can narrow your search by cancer type, province/state, and cancer treatment center. Let your doctor know if you are willing to consider participation in a trial. In Canada, there is usually no monetary compensation for your participation and importantly, no recourse in the case of failure.
Clinical Trials Resources:
http://www.canadiancancertrials.ca/
http://www.cancer.gov/clinicaltrials/
http://www.clinicaltrials.gov
http://www.centerwatch.com
http://cancertrials.nci.nih.gov/clinicaltrials
My Related Blog Posts:| 8/28/11 | Follow up Creating Your Own Clinical Trial/Nabilone |
| 7/26/11 | Creating Your Own Clinical Trial |
| 6/08/11 | The Business of Hope |
| 5/20/11 | ASCO 2011 |
We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.
