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Volunteering for Clinical Trials

A clinical trial is a research study to find out if a new treatment will help prevent, detect, or treat a disease. Clinical trials are designed to see if the new treatment is safe and better than the treatment we already have.
 
There are five kinds of clinical trials:
  • Treatment trials test new treatments, medicines, or devices
     
  • Prevention trials look at ways to prevent disease, using medicines, vitamins, vaccines or lifestyle changes
     
  • Diagnostic trials find better tests or procedures to diagnosis a specific condition
     
  • Screening trials test ways to detect or diagnose diseases
     
  • Quality-of-life trials try to find ways to make life better for people living with a health condition

What Can I Expect if I Take Part in a Clinical Trial?

 

It is normal to be nervous about entering a clinical trial. The exact process will depend on the type of clinical trial. Here are some basics you can expect if you take part in a clinical trial:

  • The clinical trial team will include doctors, nurses, and other health care professionals. You will receive your study care at a hospital, university, clinic or doctor's office. You should still see your primary care doctor or specialist during the clinical trial.
     
  • The clinical trial doctor will examine you before you begin the study. You may find that you need more tests and doctor visits than you normally would. These tests will help doctors follow your progress and collect the data they need for the study.
     
  • You will need to follow the instructions for taking part in the study. For example, you may be asked to take study medications, change your current medicines or change your diet or activities.
     
  • You will be watched carefully during the study, and you will have to keep in touch with the clinical trial team. If at any time during the study you and your doctors feel that you should leave the trial, you can.

What is Informed Consent?

 

Before volunteers can enter a clinical trial, they must sign an informed consent form. This form tells about the risks and benefits of the study so they can decide if they want to take part.

 

The informed consent process does not end when you sign the form. After you enter a clinical trial, you will keep getting new information that may affect your decision about staying in the trial.

 

The informed consent form is not a contract, and you are free to leave the clinical trial at any time. If you decide to leave the trial, you should tell the study doctor or coordinator, so they can record your reason for leaving.

 

What Are the Possible Risks?

 

Because the study treatment is new, doctors cannot know all of the risks and side effects at the start of a trial. The risks of a clinical trial would depend on the disease and treatment being studied:

  • There may be bad or even life-threatening side effects
  • The treatment may not work
  • You may not get the new treatment. Many trials compare the new treatment to the current treatment or to placebo.
  • You may have to make many trips to the doctor, undergo a lot of testing and treatment, or even stay in the hospital

What Are the Possible Benefits?

 

Here are some benefits you may receive:

  • You may get a new treatment before anyone else does
  • Clinical trials can save lives. These studies give doctors the information they need to keep developing new treatments that may help others in the future.
  • You will get expert medical care by study doctors who are specialists in the disease being studied

How Safe Are Clinical Trials?

 

Many people have fears about the safety of clinical trials, and wonder if they are gambling with their health. The U.S. government has set up safeguards to protect people who take part in a clinical trial. The Food and Drug Administration (FDA), the National Institutes of Health (NIH) and other federal agencies oversee medical research in the United States. Understanding these safeguards may help to ease some of your fears about clinical trials.

 

During a clinical trial, you will be closely watched to see how the treatment is working and if you have any side effects. All the results are carefully recorded and reviewed. The results of the trial must be reported at scientific meetings, to medical journals and to the government.

 

All clinical trials are reviewed and approved by an Institutional Review Board (IRB). The IRB is determines if the clinical trial is ethical and protects the rights and safety of the trial volunteers. IRBs also make sure that volunteers are chosen fairly and that informed consent is done right.

 

A Data Monitoring Committee is used to review safety information throughout a study. These committees are used mostly for trials that compare two or more treatments. The Data Monitoring Committee can stop a study at any time if it finds that a treatment is not helping or actually harmful or if one treatment is much better.