You are here: Home Managing Your ... Clinical Trials ... What Is A ...
Information about all aspects of finances affected by a serious health condition. Includes income sources such as work, investments, and private and government disability programs, and expenses such as medical bills, and how to deal with financial problems.
Information about all aspects of health care from choosing a doctor and treatment, staying safe in a hospital, to end of life care. Includes how to obtain, choose and maximize health insurance policies.
Answers to your practical questions such as how to travel safely despite your health condition, how to avoid getting infected by a pet, and what to say or not say to an insurance company.

What Is A Clinical Trial And How Does A Clinical Trial Work?

Next »



  • A clinical trial is an organized study with tight controls to answer questions about a new drug or treatment or a new way of using existing ones.
  • A clinical trial has a strict set of controls and guidelines that are approved by the FDA.
  • There are different types of trials for different purposes.
  • Your role as a participant in a clinical trial is to follow the trial's protocol.  If you decide to stop following the protocol, or participating in the trial, you can withdraw at any time.

What is a clinical trial?

A clinical trial is an organized study to answer specific questions about a new drug or treatment or a new way of using an old drug or treatment.  The purpose is to find new and better ways to help patients in general, rather than to help a particular patient.

  • Clinical trials are conducted on people.
  • Clinical trials are closely monitored and must follow exact steps to help insure patient safety. 
  • Eligibility to be in a clinical trial depends on factors established for the particular trial. For example, consideration may be given to factors such as the type and stage of your condition, and what types of treatment or therapy you have received in the past.

The new therapies studied in clinical trials are tested on people only after laboratory and animal studies indicate promising results. The majority of clinical trials are conducted in three steps, commonly referred to as phases. Phase I trials establish initial safety data, while phase II and III trials explore the dose and effectiveness of the compound. Each phase of a trial builds upon information provided from the earlier phases. (For more information about phases of clinical trials, click here.)

The FDA (Federal Food And Drug Administration) reviews the data and upcoming clinical trial design and either allows the research to proceed or stops it if serious or unexpected safety issues are observed.

How A Clinical Trial Works

A clinical trial starts with a drug or treatment and a "protocol" -- guidelines that are to be followed in the delivery of the drug or treatment which include:

  • Dosage amount and when delivered.
  • Length of time for the trial.
  • Markers to be checked.
  • Symptoms to be watched for.

In order to determine the effectiveness of the drug or treatment being tested, what happens in people who are taking the drug or treatment is compared to people who are doing nothing or taking a standard treatment.

With most clinical trials, this is accomplished by dividing the participants in the trial into two groups: people who will receive the new drug or treatment and people who won't. The second group either continues with a standard drug or treatment or is given a placebo basically a sugar pill that looks like the drug being tested.) Placebos are not generally used in studies involving people with a life-threatening health condition. All participants enrolled in studies that use placebos are informed in advance of the possibility of receiving a placebo rather than the experimental treatment.

The team that actually conducts the trial will include doctors, nurses, other health care professionals, and often social workers. They will:

  • Check your health at the beginning of the trial.
  • Provide you with specific instructions for participation.
  • Monitor your health during the course of the trial to determine the safety and effectiveness of the treatment.
  • Possibly stay in touch with you after the study - usually to monitor long term effectiveness and safety.

For all types of trials, you will work closely with the research team.

There are protections for participants built into all clinical trials.

The time and commitment requirements for participation in a study can vary greatly, depending on the trial. Commitment requirements are generally greater than the requirements for standard treatment. Some clinical trials require more testing or monitoring and possibly a greater number of doctor visits or hospitalizations than you would normally have for your illness or condition. Some trials may also include complex medication dosing schedules.

It is important that participants follow the treatment protocol carefully.

Your role while in a Clinical Trial

It is your job during a trial:

  • To stick to the protocol. Do what you're agreed to do -- and don't do what you're not supposed to.
  • To report if you do not stick with the protocols. Some people don't report non-compliance because of an overriding fear of being kicked out of a trial, or that they only tell doctors what they want to hear. However, people's lives are at stake. The investigators need to know the facts.
  • To report the effects of the drug or device accurately. The most accurate method of reporting accurately is to keep a health journal on a daily basis. 
  • To follow your own health markers. If the drugs are not working for you or your health is deteriorating, you need the information to decide whether to leave the trial.
  • To keep up to date about what the investigators are learning throughout the course of the trial. It's the only way to be aware of new information that may affect your decision to continue in the study.

If you decide to withdraw from a clinical trial

You can withdraw from a clinical trial at any time.If you decide to leave, no formal documentation is necessary.

  • Before leaving the trial, discuss your reasons for leaving with your doctor. She may have a different view of how you're doing in the trial than you do.
  • Make plans for continuing your health care after no longer accessing whatever care or tests are provided by the trial.
  • Let the research team know. Tell them the reasons for your leaving the study. The information could be useful to other people in the same situation you are.

NOTE: If you would like to see a series of videos that explain cliical trials,the National Cancer Institute helped develop a tool that explains clinical trials in a series of short videos. See:   offsite linkSearch on: Preparatory Education About Clinical Trials.

Please share how this information is useful to you. 0 Comments


Post a Comment Have something to add to this topic? Contact Us.

Characters remaining:

  • Allowed markup: <a> <i> <b> <em> <u> <s> <strong> <code> <pre> <p>
    All other tags will be stripped.