Before drugs are available over-the-counter or by prescription, they have to be tested on people. These tests are called clinical trials. Read some general information about clinical trials, excerpted from Enroll-HD, and discuss the following questions with a partner or group.
Part One: Reading
A clinical trial is a way to systematically test whether a new drug or other kind of therapy can prevent, treat or cure a disease in people; they are sometimes called “interventional” trials (which are different from “observational” studies like Enroll-HD). Clinical trials often test drugs, but all kinds of other treatments—different diets, exercise and physiotherapy regimens, deep brain stimulation, surgical procedures, etc.—may also be tested this way.
Why do clinical trials?
No matter how good a new drug or treatment seems to be in animal models, it needs to be tested in a large group of people to show that it really works and to find out what side effects it might cause. Sometimes only a small percentage of people benefit, or sometimes dangerous side effects show up in only a minority.
Why do clinical trials move slowly?
Recruitment has a lot to do with it. Finding the right people to volunteer for a clinical trial is time-consuming, especially for rare diseases like HD. According to one estimate, getting enough volunteers typically takes twice as long as originally planned. Another reason that clinical trials can take so long is that safety is paramount and there are lots of regulations that must be complied with, meaning lots of paperwork and bureaucracy, for very good reasons.
What protects my safety in a clinical trial?
No international organization supervises clinical trials, but nearly all must get approval from either the US Food and Drug Administration, the European Medicines Agency, or both. In the US and Europe, almost all clinical trials also have oversight from an Institutional Review Board or IRB. This board includes doctors and scientists as well as community members. All trials involve some risk, but this board reviews the protocol for how the study will be conducted to make sure that the risks are reasonable and in proportion to the potential benefit. The informed consent form that you sign before you begin a clinical trial will clearly spell out the potential risks and benefits.
Will I get better care if I sign up for a clinical trial?
Not necessarily. Most trials don’t include complete medical care—you will still go to your regular doctors. Also, while sometimes the new drug or treatment is a real improvement over current alternatives, it may turn out not to be very effective, or it may cause side effects.
Part Two: Discussion
- In addition to drugs, what else do clinical trials test?
- What are some benefits of clinical trials?
- The article lists several reasons for clinical trials move slowly. Summarize them with your group and brainstorm any other factors that could slow down clinical trials.
- After reading the information about safety, how safe do you feel clinical trials are? Why?
- If you or someone you know volunteered for a clinical trial, what concerns would you have and why?
- Do you think you would ever volunteer for a clinical trial? Why or why not?
References
How Does a Clinical Trial Work? (n.d.). Retrieved July 4, 2017, from https://www.enroll-hd.org/what-is-a-clinical-trial