One of the first things people will ask themselves when considering joining a clinical trial: “is this safe for me?” This is a very good question to ask yourself, but in all honesty, no one can claim that any clinical trial will be 100% risk free. If anyone does tell you otherwise, then they must be pretty desperate to recruit you, and are probably trying to meet their enrollment goals! Also, if you ever hear someone claim that there are no risks associated with joining a clinical trial, RUN away, and tell me all about it here. After all, there wouldn’t be a need for conducting clinical trials if the drugs they are testing were risk free. Therefore, no clinical trial is truly “safe”. So if you are looking for an answer to your question that is absolutely, without a doubt, 100% yes, then a clinical trial is just not right for you. Once you reach the decision to continue exploring the possibility of joining a study, you have to ask yourself what degree of risk am I willing to take?
Phase 1 studies have the most risk involved. As explained in a previous section, this is the first time a study is being conducted in humans, so the side effects of the drug are nowhere near being understood or discovered. Up until this point, the drug was tested in animals, but the effects on humans is virtually unknown outside of the theories established by scientists. However, these types of studies pay the most money to its participants, and many people are perfectly ok with the risks in order to get their compensation. The possibility of getting placebo also plays a role here. It is from these studies that the terms “human lab rat” and “professional guinea pig” originated.
Phase 2 and 3 studies have relatively similar degrees of risks. The toxicity of the drug as well as its major side effects have most likely been determined. Now the drug is being tested on the actual targeted population that the drug was designed for. For example, a Phase 1 trial may test a diabetes drug on a healthy person, but in a Phase 2 and 3 trial, a person with diabetes will test the study drug. The risks here are still side effects that may be unknown, but now we also throw in the possibility of your disease or disorder worsening rather than improving. With this added risk of a worsening condition due to getting a placebo or perhaps the fact that the drug doesn’t work, you must calculate whether you should consider joining the trial if you are actually doing well with your current treatment. These studies also pay significantly less than the phase 1 studies due to less relative risks, and the possibility of an actual purpose for the drug in treating your current condition. The risks are calculated differently if you do not respond well to your current, pre-study treatment and are willing to try the study since you may have less to “lose”. In this case, if the drug doesn’t work for you, you are now in the same position as you were before.
With all these different possibilities and combinations of risks versus your expectations, you can see that the subject of clinical trials truly varies on a case by case basis, and almost no blanketed statements can be made except for perhaps the fact that no matter what the outcome for your particular case, data was collected and science was advanced, if even a little.