If you receive your health care at a major medical center you may have seen flyers soliciting your participation in clinical trials. So what are clinical trials? What are the responsibilities of the researchers? And most importantly for you, what are the benefits of joining a study?
There are two basic types of clinical trials: interventional and observational.
In an interventional study, participants undergo an assigned treatment: for example, taking a drug, eating a particular food or using weights to exercise a particular muscle. The researchers then record the outcome of the treatment on the question being studied.
Observational studies are those in which researchers select a particular characteristic to observe—how drinking coffee affects the likelihood of getting a cold, for example. Participants might be asked about their coffee consumption and the number of colds they contracted over a specified period of time. When the researchers compare the data for all of the participants they would be able to see if a relationship existed between coffee drinking and infection with the rhinovirus. Clinical studies are built upon a hypothesis or research question. Usually the hypothesis is formed in the positive: Taking drug X will reduce blood pressure. The study is then designed to determine if the statement is true.
All clinical trials use protocols. A protocol is a set of rules that determines how the study will proceed, so all study investigators follow the same guidelines when working with participants. This helps ensure that the results of the study won’t be biased.
As part of its protocol, each trial selects who can and cannot be a participant based on a set of criteria called inclusion and exclusion criteria. Studies will include or exclude certain people based on the aim or hypothesis that the study is trying to prove.
For example, researchers may want to see if a blood pressure drug that is safe in adults can be used in children. For a trial involving children, anyone over 18 would obviously be excluded. Children will high blood pressure would be included.
Often people who are in enrolled in a clinical trial not only help contribute to the body of research about a particular disease or topic but also receive personal benefit. They can, according to NIH,
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the trial.
- May, in some cases, receive financial benefit.
If all of this sounds exciting why doesn’t everyone sign on? Just as in other areas of life there can be some downsides to participating.
- There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
- The experimental treatment may not be effective for the participant.
- The study may require more of their time and attention than the person has time for, including trips to the study site, more treatments, hospital stays or complex dosage requirements
Before you decide to join a study, it is important to get all the facts.
The following questions might help you decide if joining a trial is something you want to do. Some of the answers to these questions are found in the informed consent document. (The consent document provides you with information about the study and the possible risks to you of joining)
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this study?
- How will I know that the experimental treatment is working? Will results of the trials be provided to me?
- Who will be in charge of my care?
You can find additional information about clinical trials here
If you live in the Boston area, check out the clinical trials happening at the Joslin Diabetes Center.