What to expect before, during, and after the clinical trial
Your experience with a clinical trial goes through three phases:
- Before the trial: informed consent
- During the trial: your care
- After the trial: learning results
The following sections describe each of these phases.
Before the trial: informed consent
When you first meet with the research team, they will walk you through a process called "informed consent" to discuss:
- The purpose of the study
- Tests and procedures involved
- Possible risks and benefits
- If there will be any costs to you
- How the researchers will protect your privacy
- Your rights as a participant in the trial
- Any concerns you may have
You will be informed about new benefits, risks, or side effects that may be discovered during the trial. You may also be asked to sign a new consent form that identifies these updates to the study.
Short-term risks are usually easy to identify. You'll see them outlined on your consent form. Long-term risks are often not well known because the drug or device hasn't been around long enough for the data to be available.
Questions for your team
Before joining a clinical trial, you'll probably have questions for your research team, such as:
- Who is sponsoring this study?
- What is the goal of the study?
- How do you determine if I'm eligible for this trial?
- Will I benefit from participating in this study?
- What are the risks if I choose to participate?
- What is the usual treatment for my condition?
- How different is this trial from that treatment?
- Does my participation affect the care that I will be receiving?
- What will be expected of me if I participate?
- How many times will I need to come to DHMC?
- What will happen each time I am there?
- Will I be expected to pay for anything?
- Will my insurance be expected to pay for anything?
- How long will the study last?
- What happens to me when the study is over?
- What happens if I decide to leave?
We can't answer those questions now, of course, but bring them to your team, along with any other concerns you have.
Be sure to remember that you are free to leave a trial at any point and that, whatever your decision, you will receive the same comprehensive care at Dartmouth-Hitchcock.
During the trial: your care
When you volunteer for a clinical trial, some visits and procedures collect information related only to the study. Other visits and procedures are part of the usual care, often referred to as "standard care,” for your condition which would be provided even if you were not in a clinical trial.
Being part of a clinical trial is not the same as being treated for a specific disease. Your routine care will continue with your regular health care providers while you take part in the research study. The important thing to remember is that the choice of whether or not to enter a clinical trial is completely up to you.
After the trial: learning results
Ask your research team if they know when the study will be completed and the results published. You can also see results of completed clinical trials at clinicaltrials.gov, a database run by the National Institutes of Health.
Keep in mind, though, that sometimes a trial needs to end before it is completed, or the trial is ongoing and does not have a specific end date.
Ensuring your safety
All trials through Dartmouth College, Geisel School of Medicine at Dartmouth, and Dartmouth-Hitchcock Medical Center are conducted according to strict scientific and ethical principles.
Every clinical trial has a plan, called a protocol, describing what will happen in the study and why it is necessary. Before a trial begins, a committee reviews the protocol and approves it only if the clinical trial meets certain standards.
At Dartmouth-Hitchcock Health, this group is called the Human Research Protection Program (HRPP). The committee evaluates the scientific basis for the trial, the risks to participants, and the information participants receive.
The HRPP continues to oversee the study while it is in progress, and can stop a trial that does not meet their approval or is causing unexpected harm to participants. They also can halt a clinical trial if the treatment being studied is very effective, in order to make it available sooner to patients who are not on the trial.