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Clinical Trials

Robin Reesal, MD, FRCPC
Western Canada Behaviour Research Centre
Calgary, AB

My name is Robin Reesal and I'm the Medical Director of the Centre for Depression and Anxiety in Calgary, a division of the Western Canada Behavior Research Centre. This is a freestanding centre that's devoted to doing clinical trials and treating individuals with depression and anxiety; it's a not-for-profit organization and it's unique in Canada. Part of the purpose of this organization is to further the development of psychotropic agents for the treatment of disorders in this area.

 
q How do people get involved with clinical trials?
a Well, there's a trend in Canada for family physicians to become more involved in clinical trials so they may have a contact that way. As well, they may have contact with specialists who are participating in clinical trials and patients are returned to their care after being on a trial or during the time they've been on it, so it is very hard to avoid contact with the trials today. There are several different phases of trials, from Phase 1 all the way to Phase 4 and physicians may be involved with the Phase 2, 3, & 4. The Phase 2 is the early development of a drug on a small number of patients suffering from the condition; Phase 3 involves a larger number of patients taking the particular treatment - and here we are looking for the efficacy and the side effect profile and dosing issues; and finally, the Phase 4 trials usually involve a post-marketing study in which larger numbers of patients are participating in these trials. Family physicians may be involved in the Phase 3 and Phase 4.
   
q Are family physicians reluctant to get involved in trials, do they feel it's more of an academic issue rather than something that relates to their daily practice?

a Our own experience at the Western Canada Behaviour Research Centre in polling physicians who've participated in clinical trials is that they've found the clinical trial to be a very worthwhile experience. Many family physicians don't have an academic affiliation, yet they maintain interest in research and have never been given the opportunity to participate. Participating in a trial gives one the opportunity to be brought up to date on the particular area that you're looking at - it exposes you to research principles. Part of research principles is the process of looking at yourself and how you practice medicine, looking at the process that's taking place and then having the evaluation of the particular treatment that has been offered. It provides a nice bridge for those individuals who may feel quite excluded and not part of academia and gives them a chance to see research principles being introduced and carried out again.
   
q Is it a lot of work to get involved in a trial if you are a GP and interested in the academic side of things?

a One of the things about our own centre and looking at the development and association with clinical trials is that it provides an alternative means of offering care to a patient. It is more time consuming in that you are looking at formalized processes by which you are giving care to patients. But it is worthwhile -- and this is one area of research where you still get to maintain your patient contact. You will learn something more. So academically, it's good. At the end of the process, you get to have participated in something that brought about a particular result for treatment that was either a benefit to the individuals or perhaps not so. It also makes you less isolated in your own practice and gives you a chance to see how the experts would carry out a particular treatment in this area. And it lets you know that your standards are as good as anyone else's in the country.
   
q Does participation in a clinical trial make you more critical in a good way of clinical trials that are reported in the literature both in terms of how you read them and perhaps the weight that you give to their results?

a Much of the learning taking place in our medical career is that the pharmaceutical industry is unsavory and that they are salesmen who are going to try and sell you a particular agent. By participating in a trial, it allows you to see for yourself whether these things that we have heard from third parties are actually true. It also gives you an opportunity to participate in the industry and to change the standards if you are not happy with them, and I think this is very important. Many agents will not be good drugs and some treatments are not valid and it gives you a chance as a physician to have a say in the furthering of a particular product.
   
q So many of our clinical trials are funded by the pharmaceutical industry. Is there some concern, and rightfully so, among physicians that the funding from a particular pharmaceutical client will indeed skew the information and give us information that is perhaps not as relevant as you might like it to be for clinical practice?

a When you participate in a clinical trial, it is very important to know what stage you are participating in. For example, is the drug already on the market? That's important because if it's not, then you are usually participating in a Phase 2 or Phase 3 in which you are helping or playing a role in defining whether this treatment is valid and whether it will be well accepted and have a role in regular clinical practice. So there is a great deal to gain regardless of who is funding the study. I think there is a tremendous amount of controversy around Phase 4 trials as to whether these are just marketing opportunities for the pharmaceutical industry to further the use of their particular agent. So what phase the trial is in is very important to know when you are evaluating a study to decide whether you should participate or not.
   
q If GPs would like to persevere and get their patients enrolled, and the patient seems to fit the criteria of the trial, how do you approach a patient? Patients may well be a bit skittish because the drug is, after all unproven?
a One of the things I've learned over the years from participating in trials is that because the process is so formalized, we are actually required to give more information about a particular treatment than one would normally do. In participating in the trial, you usually have more time to spend with the patient. Consent is a very important issue and usually all the advantages and disadvantages are stated very clearly so that the individual actually knows more about the particular treatment you are going to offer than in other situations. One of the things that we have found most helpful for people and it helps us in terms of not pressuring anybody is when we look for participation in a trial, we read the consent form, or I will personally read the consent form over with the patient, then leave a minimum of 24 hours between the time you read it and when the patient returns and signs the consent form. This is very important from an ethical standpoint because there is a difference in the power structure between the physician and the patient and often times, the patient may want to please the physician. So when they go home and they have the consent form and they get to talk it over with their family member or someone else who is important to them, their decision may change. One of the concerns is by doing this, we may decrease enrollment. In fact, it has not had that effect at our site. What we've found is that if someone actually did sign, went home and then changed their mind, they'd probably be unhappy with the care being offered, or would find another reason to come off of the trial early. So it's better to have individuals who understand the process, who feel comfortable with it, and then if anything untoward did happen during the trial, you'll feel that the person did make an informed consent at the outset. After all, it is your reputation and it is your clinical practice that is on the line every time you do treat a patient.
   
q In terms of GPs just finding out in general about clinical trials that they might wish to participate in, is there any one source of information? How would they find out about participating?

a To my knowledge, there is no one organization in Canada that provides information for family physicians with regard to trials, and this is not just a problem from the medical side, but also from the industry side. One of the concerns is, how is it that pharmaceutical companies are picking their sites for participation? Are they doing it on politics, are they doing it on skill of the physician, are they doing it on the patient load - and much of this has been undecided. If you were to ask me what criteria should be used, well obviously someone who has an expertise in an area, who has a large number of patients who have the particular condition, a physician who has interest in the area, also who is willing to participate and to learn something for the betterment of themselves educationally and for the patients. Those would be the criteria.
   
q What do you like about participating in clinical trials?
a I've participated in clinical trials for the last 10 years, and have been involved in the marketing of almost all of the new antidepressant medications, and the part that I've enjoyed most is the constant re-evaluation of what I do, and the feedback, and getting people better. One of the things that most people are taught in medical school is that it's a chronic, long-term process to get a depressed patient better. In most cases, we have our patients better within a few months and it gives us a great deal of joy to see individuals improve and the change it makes in their quality of life.
   

 

 

 

 


Over one million Canadians suffer from some form of depressive illness.