Being involved with several clinical trials (such as this one for Bipolar Depression in Boston) and patients, I often come across common misconceptions related to clinical trials. So I thought it would be useful to summarize and address some of these issues.
Misunderstanding about Visit windows and scheduling
Clinical trial protocols sometimes have very narrow time frames in which to schedule visits. There may only be one or two days of flexibility. If everyone else had their assessment at week 5 and yours was at week 6, the results cannot readily be compared. In a few cases participants in our trials were unable to come during the specified time frame and we were forced to withdraw them from the study. People are typically confused and upset when they are told that they can no longer participate. In one case, a subject told my co-worker that I had acted unprofessionally when I canceled an MRI visit due to equipment problems but gave him only two days to reschedule. After I explained everything to him and asked how he felt that I should have handled the situation, he was very understanding. Scheduling is sometimes very challenging, since I have to consider the participant’s availability, the doctor’s availability, the availability of required equipment (MRI machine, etc.), and any restrictions based on the study protocol such as time of day. If the visit has to be one week after the previous visit, the protocol may specify how many days you can stretch it in either direction and the window is usually not very long. We had one study where women had to have their first MRI visit just before their menstrual period. There were a few cases where our predictions were a little off and we had to wait an entire month. After that I told the doctor that we should study men! I do everything in my power to accommodate work and school schedules, desire to avoid traffic, and other preferences. We offer Saturday and evening hours for people who work. But there are times when I simply can’t make things work. So please be understanding when the study coordinator seems inflexible in scheduling.
Misunderstanding about Compensation for Clinical Trials:
While some studies offer compensation for time and travel, the main objective is not to make a profit. Healthy volunteer studies may be an exception. When I explain our studies to prospective participants, I tell them the payment schedule and state that they will not receive any money for several weeks and that even then it will be the first $25 and not a lump sum. People have hung up on me or told me that they are no longer interested when they hear that the study will not give them a quick $200 or $600. There are a few reasons why the monetary incentives are not better. One is that we simply don’t have an unlimited supply of money to hand out. The other is a concern that people will make decisions that are not in their best interest or lie about their eligibility in order to receive compensation. There are risks involved in research, such as medication side effects or a possibility that you won’t get better. If the financial rewards are too high, people ignore those risks. An ethics committee (usually called an Institutional Review Board in the United States) reviews the compensation to ensure that it is appropriate and will not approve anything that could lead people to make poor decisions based on financial rewards.
Misunderstanding about Receiving Free treatment:
I have seen people improve markedly during our studies, watching scores on depression scales drop to almost zero. One woman stated that we gave her back her life. I have also seen people who were no better at then end of the study than they were at the beginning. In clinical practice, the doctor probably would not wait 10 weeks to make a medication change for patients who showed no improvement. In research, the primary objective is to determine whether the treatment works as opposed to treating the individual patient. You may be assigned to a placebo group (inactive pill with no medication), the intervention being tested may not work, or the intervention may work for other people but not for you. On the other hand, you may have a chance to get a medication or other treatment that is not available any other way. And of course, you may get better. One thing to consider if you are receiving an investigational treatment is whether you can get it after the study if it does help you. If the drug is already on the market for something else, your doctor can prescribe it “off-label”. However, if the treatment is not approved by the FDA for anything, you may not have access to it after the study ends. The other thing to bear in mind is that you have the right to withdraw from a study at any time if you change your mind, particularly if your condition gets worse. In this case, you should inform the study staff rather than simply not returning for your next visit. They may want to schedule a final visit to ensure that you safely transition to treatment outside of the research study.
Be sure to ask questions if you don’t understand anything. You will sign an informed consent form, but informed consent is a process that continues throughout the study. Research staff members are willing to spend time with you to ensure that you have the best possible experience while participating in the study.
Refer to this series of articles on the basics of clinical trials to get more information
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