Clinical Trial FAQs
What is a clinical trial?
A clinical trial is a research study in which new treatments for a disease are tested in patients. When preclinical and/or laboratory research shows promising results with a cancer treatment, the pharmaceutical company files an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA).
Who can participate in a clinical trial?
Each protocol has clearly defined inclusion and exclusion criteria that define which patients are eligible for the trial. Even after fulfilling these criteria, patients may need to go through additional screening including laboratory tests and a medical history to assess whether they are eligible.
Why should I participate in a clinical trial?
Only you can determine if participation in a clinical trial is right for you. Your doctor can help you weigh the potential risks and potential benefits, if any, of participation.
What are the benefits of participating in a clinical trial?
- Taking an active role in your healthcare
- Access to experimental treatments before they are widely available
- Ability to receive expert medical care
- Contributing to medical research
What are the risks of participating in a clinical trial?
- All treatments have side effects.
- For experimental treatments, these side effects may not be fully recognized or understood.
- Participating in a clinical trial may require multiple trips to the trial site, more treatments, hospital stays, and complex dosing.
What is informed consent?
Each protocol has clearly defined inclusion and exclusion criteria that define which patients are eligible for the trial. Even after fulfilling these criteria, patients may need to go through additional screening including laboratory tests and a medical history to assess whether they are eligible.
What questions should I ask before deciding to participate?
- The Trial
- What is the purpose of the trial?
- Who is going to be in the trial?
- Why do researchers believe this treatment might be effective? Has it been tested before?
- Who has reviewed and approved the trial?
- How long will the trial last?
- Where is the trial being conducted?
- Who is sponsoring the trial?
- Possible Risks and Benefits
- What risks are involved?
- What are the potential short-term benefits?
- What are the potential long-term benefits?
- How do the potential risks, side effects, and benefits compare with my current treatment?
- What happens if I am harmed by the trial?
- Participation and Care
- What kinds of tests and experimental treatments will I have to undergo or take during the trial?
- Will hospitalization be required?
- Will patients be able to take their usual medications during the trial?
- What type of long-term follow-up care is part of this trial?
- How will I know that the experimental treatment is working? Will the results of the trials be provided to me?
- Who will be in charge of my care?
- Will I still see my usual doctor?
- Personal Issues
- How might my participation in this trial affect my daily life?
- Cost Issues
- Can I remain on the experimental treatment after the trial ends?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- Do I have to pay for any part of the trial?
What types of clinical trials are there?
Clinical trials may be interventional in which the effects of an intervention or a treatment are assessed. Clinical trials may also be observational in which events are observed without intervention.