Who can participate?
All clinical trials have guidelines about who can and cannot participate. By using inclusion/exclusion criteria, ACRO members can ensure reliable results while protecting participant health and safety.
- Inclusion criteria include factors that allow someone to participate in a clinical trial.
- Exclusion criteria include factors that would prohibit from someone participating.
These criteria are based on a variety of factors, including:
- Type and stage of a disease
- Previous medical or treatment history
- Other medical conditions
The factors influencing these criteria change depending on the trial and treatment being tested. For example, some research trials may need participants with a specific illness or even a specific genetic sequence in their DNA, while others seek healthy participants.
A trial’s inclusion/exclusion criteria ensure only qualified participants are accepted for clinical research, protecting their health and safety.
What happens during a clinical trial?
While each clinical trial varies depending on the kind of study being conducted, the clinical trial team generally includes doctors and nurses as well as social workers and other healthcare professionals who:
- Check the health of the participant at the beginning of the trial
- Give specific instructions for participating in the trial
- Monitor the participant carefully during the trial
- Stay in touch after the trial is completed
Clinical trial participation is most successful when protocol is followed carefully and there is frequent contact with the research staff.
For patients, there is a lot to consider before choosing to participate in a clinical trial. Before doing so, it helps to talk to your physician, family members, friends, or others, about your interest in joining a study.
What should people consider before participating?
It’s important to know as much as possible about the clinical trial you are considering. Ask members of the healthcare team questions so you can know what to expect, especially with consideration to the care provided and what the trial may mean for you. Here are some important questions you should consider:
- What is the purpose and who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective?
- Has this drug, device, or treatment been tested before?
- What are the possible risks, side effects, or benefits involved?
- How long will the trial last and how will it affect my daily life?
- 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?
Preparing for a clinical trial
Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) — an independent committee of physicians, statisticians, community advocates and others — to minimize risks and ensure that the benefits outweigh those risks. Outside the U.S., these bodies are generally referred to as Ethics Committees, and function in the same way.
Before meeting with the study doctor, research team, or other members of the trial process, you should:
- Plan ahead and write down possible questions (like those above) to ask.
- Ask a friend or relative to come along for support.
- Use your phone or bring a tape recorder to record the discussion to replay later so you have all the facts.
Can a participant leave a clinical trial after it has begun?
Absolutely. A participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
For more information about joining clinical trials