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Clinical Trials 101


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Clinical trials are a way to access cutting edge medical treatments.  Today's standard treatments are yesterday's clinical trials.

A clinical trial is a carefully controlled study to answer specific questions about a new drug or treatment, a new way of using an old drug or treatment or a new diagnostic tool. It is a myth to think that people who participate in clinical trials are used as "guinea pigs."  Trials are not conducted until scientists and researchers have done a great deal of research in the laboratory and possibly on animals.  All clinical trials are required to follow federal regulations which includes a jprovision that each study must be subject to an institutional review board (IRB) which reviews and monitors the study.

Advantages of clinical trials: Clinical trials can be particularly useful for people who are not able to find a cure or symptom relief with standard treatments. In addition:

  • Participants have the advantage of getting access to a drug years before other patients. This can be particularly useful if the drug being investigated is successful. .
  • Participants have a team of doctors looking at their situation rather than just one.
  • Participants know that other people are being helped because of their participation. This is especially if the trial is successful. It is even true if the trial isn't successful. 

Clinical trials are conducted in three phases.

  • Phase I trial: The purpose is to determine the safety of the treatment for humans and the best way to administer the treatment.
  • Phase II trial: Doctors study the effectiveness of a treatment.
  • Phase III trial: 
    • A control group of patients receives the standard treatment. Another group in the trial receives the new treatment. This technique permits doctors to compare the effectiveness of the two treatments. 
    • Side effects are monitored. If the side effects are too severe, the trial is discontinued.

You can find a clinical trial through a variety of ways, including seaching online.

If you are considering joining a clinical trial, it is advisable to start looking for a trial as soon as possible to maximize your chances of qualifying. Qualifying rules vary from trial to trial. Some trials only take people who have not been treated at all. Others require specific prior treatments etc.  

Before joining a clinical trial, take whatever time you need to absorb all of the information about the pros and cons of joining the trial. Get expert avice. For example from your specialist or primary care physician. Consider:

  • Whether your best interests would be served by participating in the clinical trial.
  • The outcome the researchers are looking for.
  • The potential reward.
  • The potential risks. 
  • Safeguards that are built in to the clinical trial to protect a participant's medical and psychological health.
  • Whether you are liable to pay any costs. Research costs are covered by the trial. If there are additional costs, they are covered by private health insurance, Medicare and Medicaid. If you are uninsured, you can negotiate costs. (For information about how to negotiata medical bill, including professionals who can help if needed, click here.)
  • How much of your time and effort is required. A trial may also require that you stop taking other medications.
  • There is no right to continue to have access to the drug after the trial is over. You may be able to continue to get the drug through "compassionate use." To assure a drug's continued availability, get agreement from the trial sponsors before entering the trial.

You can leave a clinical trial at any time, for any reason. 

Sometimes trials pay people to participate. It is advisable to ake the decision about whether to join a trial based on the possible benefits to your health, not for the money.

Your doctor's approval or referral is not necessary to allow you to enter a clinical trial. However, it is advisable to discuss with your doctor whether to join a particular clinical trial. Your doctor may be able to provide valuable insight and advice. Your doctor should also know about all drugs you are taking. If he or she advises against a particular trial, ask why. 

If you are thinking about joining a clinical trial conducted by your own doctor at his or her suggestion, consider seeking a second opinion from another doctor who is not connected with your doctor. A second opinion helps assure that the suggestion you enter the trial is because of your interests rather than your doctor's. For information about obtaining a second opinion, click here.

For additional information, please see:


  • Many patients are concerned about joining a trial because they do not want to receive a placebo. Basically, a placebo is a pill that looks like the real pill, but is a dumy instead. Trials for serious health conditions tend to compare a new drug against the most effective current treatment. So, while participants in trials which include a comparison do not know what they receive, at the least it is the most effective current treatment.
  • If you cannot obtain a drug through a clinical trial, you may be able to obtain it through Compassionate Access or by purchasing it abroad.s
  • If you have health insurance, thanks to the Affordable Care Act (sometimes referred to as "Obamacare"), insurers are prohibited from taking away or limiting coverage when an insured individual decides to participate in a clinical trial.

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