We discussed my medical journey thus far and some of the work he is involved with. Unfortunately, one of the trials he is managing was unsuitable for me because I went from a platinum based treatment to Doxil last year. His trial wants candidates straight from platinum based treatments. As you may recall I have a sensitivity to Carboplatin (platinum based) and went to Doxil treatment last September.
One of the things I wanted to talk about was the timing of entering clinical trials. It is confusing to me. Do I continue on a treatment as long as it is working and miss out on a clinical trial using an experimental drug that might do me good or jump into a trial as soon as possible? Naturally there is no hard and fast rule about this and he confirmed this. He did talk about a trial starting in several months that I may qualify for and he will keep tabs on me for this. We also talked about Princess Margaret Cancer Centre in Toronto and how this might also be an option for me. That facility does attract more research dollars and cutting edge trials which I am interested in.
I should probably talk a little about clinical trials. By the time a treatment needs to be tested it has been studied extensively in research labs and probably tested on animals. My understanding is that there are 4 phases and the process generally takes many years:
Phase I: Answers the question 'Is this drug safe.' Drug is tested for first time on humans and on a small group (15-40). Generally the people in this trial have no further treatment options. Usually conducted in major teaching hospitals.
Phase II: Answers the question 'Does the treatment work?' The people in this phase (25 - 100) usually have the same type of disease and they all receive the same dose of the drug. These people have not responded to standard treatment or are more likely to benefit more from experimental treatment. These trials are usually conducted at major teaching hospitals or smaller community hospitals.
Phase III: Answers the question 'Is this treatment better than existing treatments?' When enough people respond favourably to the treatment in phase II then it enters phase III trials. Several hundred people are usually involved and conducted across Canada and North America at the same time. Trials are usually randomized in that the participants are chosen at random to receive either the new treatment or standard treatment. The trials may also be blinded in that the participants and / or the researchers don't know which treatment the participants are getting. This is all to support scientific study objectivity and reduce human bias. If phase III is safe and effective then drug manufacturer can apply to Health Canada for approval to sell the drug by prescription in Canada.
Phase IV: Answers the question 'Is there a better way to use this treatment?' These trials study drugs that are already approved by Health Canada and are being used for standard treatments. Researchers may use these drugs to better understand treatments that have already been proven to work. A trial may show that a drug is more effective if it is given for a longer period or that a lower dose works as well with few side effects.
Dr. Welch was gracious and empathetic to my situation. If I do go to London to participate in a clinical trial I know I will be in good hands.
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