1. What is a Clinical Trial?
A clinical research study or “trial” is a scientific study evaluating a new treatment that has shown promise in laboratory studies. It is through these studies or trials that doctors find new and better ways to prevent, detect, diagnose, control and treat illnesses.
2. Who can participate in a clinical trial?
Before joining a clinical trial, a participant must meet specific requirements in order to qualify. All clinical trials have guidelines about who can participate and these guidelines are based off of factors such as age, gender, previous treatment history, and other medical conditions. If you think you may be a good fit for a particular trial you should contact the research site and consult your doctor.
3. How long does it take a drug to go through the clinical trial process before it is publicly available?
The Food and Drug Administration (FDA) requires that clinical trials be performed on all new and improved medications before that new treatment becomes available for public use. It is only after many years of laboratory testing that drugs are approved to enter the clinical trial phases. In some cases it can take from 10-15 years for a drug to go through all phases of the clinical trial process.
4. What are the benefits of participating in a clinical trial?
A well designed and well executed clinical trial is a great way for eligible participants to play an active role in their own health care, gain access to new research treatments before they are widely available, and also help others by contributing to medical research.
5. What are the risks of participating in a clinical trial?
Like any other form of research, various uncertainties and unforeseen events can occur. In some cases participants may experience unpleasant side effects, and very rarely, may experience serious or even life-threatening side effects as a result of the treatment. This is why it’s always important to consult your doctor prior to participation.
6. Can someone stop participating in a clinical trial after it has begun?
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.
7. What should someone consider before participating in a clinical trial?
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
- What kinds of tests and 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 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 treatment is working?
- Will results of the trials be provided to me?
- Who will be in charge of my care?
8. Does a person continue to work with a primary health care provider while in clinical trials?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the study requirements.
9. Clinical trials need more participants!!
According to a recent article in The Wall Street Journal, fewer than 10% of Americans participate in clinical trials and nearly 40% of clinical trials are unable to find enough volunteers to meet their enrollment goals. When this happens, delays are caused in the clinical trial process which increases the amount of time it takes to bring new medications and drugs to the public.
10. Where can someone go to learn about what clinical research studies are currently available?
To find out what clinical research studies are available, people can visit www.clinicaltrials.gov, or www.RCRclinical.com to see some of the studies that are currently enrolling in the Rochester-area. You can also speak to someone on our recruitment team by calling (585) 288-0890.