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Review Process for Clinical Trials

THE REVIEW PROCESS FOR A CLINICAL TRIAL

Who approves the clinical trial to go ahead?

For any clinical trial to be offered to patients of BC Cancer, it must receive scientific and ethical review by an institutional Research Ethics Board (REB). There are federal agencies in all countries involved in the oversight of human clinical trials as well, and they have policies and rules that determine how clinical trials can be operated in that country. The federal agencies also ensure that REBs are composed of the right mixture of experts to adequately review research. Health Canada is involved in reviewing and approving trials of new drugs in Canada. 

(http://www.hc-sc.gc.ca/dhp-mps/prodpharma/index_e.html)

How do my doctors choose which clinical trials to do?

At BC Cancer, doctors work in groups of specialists, according to what type of tumour is being treated ("Tumour Groups"). For example, there is a Breast Tumour Group, a Genitourinary Tumour Group, and Gastrointestinal Tumour Group, etc. These groups include both physicians and other types of experts, such as nurses, pharmacists, counsellors, and others. The physician members of these groups generally include surgeons, medical oncologists, and radiation oncologists, and possibly other specialists, depending on the condition. The Tumour Group members usually consult with each other and with scientists about what questions and issues in cancer treatment are of most interest and importance, and pursue or develop clinical research trials that would seem to help answer these questions. If a clinical trial protocol meets with the approval of the Tumour Group, the trial may proceed at any or all of the BC Cancer centres, once the trial has received proper regulatory approvals.

(You can click here to link to a list of open trials at each BC Cancer Centre)

At the BC Cancer, at this time, most of the phase I clinical trials are offered in Vancouver, but phase II and III trials may be available at any of the Centres. If a trial is not available in your local Centre, you may wish to consider travelling to another Centre to take part. Your doctor can help you make this type of decision.

Where do clinical trials come from?

Any member of the Tumour Group may develop their own clinical trial, but more commonly, the trial is developed by larger groups of physicians. BC Cancer physicians often participate in "Cooperative Group" trials, meaning that several cancer treatment centres are involved in developing and carrying out the research. In Canada, the National Cancer Institute of Canada (NCIC) is the major group that develops and oversees cancer clinical trials. There are also other large Cooperative Groups in North America that include many treatment centres in the United States, and these are a possible source of clinical trials. In some cases, a clinical trial is developed by a pharmaceutical company, usually in consultation with cancer treatment specialists.

Who sponsors clinical trials?

As mentioned above, the trial may be sponsored by BC Cancer, a Cooperative Group(s), such as the NCIC, and/or a pharmaceutical firm(s). Often pharmaceutical firms do provide drugs and other resources to allow the clinical research to be performed, and they are involved in collecting and analyzing the data obtained.

How do I know if there is a clinical trial for me?

Your oncologist will know whether there are any trials at your treatment centre that would be an option for you, and will offer that treatment option to you, along with other standard treatment options. If you consent to participate in a study, then some tests will usually be necessary to make sure you meet the eligibility criteria.

You can search for lists of available clinical trials at each of the BC Cancer Centres using this link.

You can also look for lists of clinical trials further away, if you think that you would potentially be willing to travel away from home to take part. Your oncologist can help you understand the available information about clinical trials, and can sometimes help you determine whether you're eligible for a trial elsewhere, if you've indicated an interest in that. Please understand that it is not possible for your oncologist to be continuously aware of all the clinical research going on in other provinces, states, and countries, and to advise you in detail about those other options.

SOURCE: Review Process for Clinical Trials ( )
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