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What is a clinical study?

What is a clinical study? Why are studies done?

Before a new medicine can be used by patients, their doctors must understand:

  • what disease the medicine treats,
  • how much better patients can expect to get,
  • and how soon they may feel better.

They must know things like whether two medicines for different diseases can be taken at the same time or if they can cause medical problems and shouldn’t be taken together.

Most importantly, they must know that the medicine is safe for the intended patients.

Clinical research studies help answer these questions.

Clinical studies are a necessary step toward making new medicines and treatments for all of us.

How are they organized?

Clinical studies are done in steps or phases.  Each phase looks at different questions:

  • Phase 1 studies are the first time people take a study medicine. Only a small number of people (usually between 20 and 80) are part of Phase 1 studies. Phase 1 studies focus on the safety of the study medicine and how much medicine may be safe to take in future studies.
  • In Phase 2 studies, study doctors begin to look at the effect of the study medicine on disease and continue to study its safety. Usually between 100 and 300 people are in a Phase 2 study.
  • Phase 3 studies are done to understand the effectiveness and safety of the study medicine or treatment. Phase 3 studies include large groups of people (1,000 to 3,000 – or even more) so that doctors can have a thorough understanding of the study medicine.
  • Phase 4 studies are done with medicines or treatments that can be prescribed for patients. Phase 4 studies are done for many reasons, including to find out more about the safety of the medicine or to see how it works for other diseases.

How are you protected?

Clinical studies and the study doctors who work in them are regulated by the U.S. Government.

The law requires that every study be reviewed by an independent group of scientists and community members, whose job is to make sure that the study is as safe for the volunteers as possible. This group is called an “Institutional Review Board” or “IRB.”

Consider volunteering for an IRB – they need community members and always need help to review studies.

The IRB looks at the plan for the study (also called the “research protocol”) before anyone can join the study. They may ask for changes in the study to make it safer for the people who will join. The IRB also looks at the participants’ confidentiality and privacy.

  • If you join a study, your name and contact information will be carefully guarded. Your information will not be in any of the reports about the study.
  • If new information that may be important to you and your decision about the study, especially information about safety, is discovered during the research, you will be informed.

Considering a clinical study…

Why join a study?

People have many reasons for joining a study.

  • Some people like the feeling that, by joining, they are helping new medicines to be made available for all.
  • They may feel that they are helping medical care to be better for their children than it was for their parents.
  • Many studies include health education and medical tests. Some people are glad to receive these and be an active partner in their health care.

Remember, your confidentiality and privacy will be carefully guarded by the study. Your name will not be in any reports about the study.

What are the risks?

A study medicine is an untested medicine.
Clinical studies are done to test the study medicine or treatment.

It is important to talk to your doctor and the study doctor about the study.
Ask them what is known and what risks they see.

When you have asked them all your questions, ask them what else you should ask.

All medicines have unpleasant side effects.

Some people may experience the side effects, and others may not. Ask the study doctor about the kinds of side effects that may happen in the study.

The study will require appointments with the study doctor.

Make sure that the schedule is convenient for you. If it isn’t convenient, ask the study doctor if it can be more flexible. These appointments are important for checking the effects of the study medicine on your health. It is important to keep the appointments.

What are placebos?

A placebo is an inactive substance.

Studies use placebos to compare with a drug or treatment to check the effectiveness of that drug or treatment.

How do I decide?

Talk with the study doctor and with your own doctor.

Ask the study doctor to explain the study – including any details you would like to know.

Feel free to ask all of your questions. The study staff want you to feel comfortable with the study.

Here are some questions you may want to ask:

  • What will I have to do in the study?
  • How long will it last?
  • How many times will I have to come for study appointments?
  • How long will the study appointments last?
  • Who will be watching out for my health?
  • What are the risks in the study?
  • Will my transportation and parking be reimbursed?

Once you have asked every question you have, ask the study doctor what else you should ask.

What to expect to in a study?

What is “informed consent”?

The study staff mentioned “informed consent.” What is it?

The U.S. government oversees medical studies that include people. One of its laws is that no person can be forced to be in a clinical study or should join against his or her will. Another law is that people who join must understand what to expect. Any person who joins a research study must “consent” to join, and that consent must be “informed.”

The study staff or doctor will give you an Informed Consent Form to explain the study. Please take your time to read it and understand it.

If you like, you may take it home and have a family member or your doctor look at the form.

If you decide to join the study, the study staff or doctor will ask you to sign the form to show that you understand what has been explained about the study. They will give you a copy of the Informed Consent Form to take home.

Responsibilities

Everyone who joins a clinical study has responsibilities to the study.

These are some of the important responsibilities that study volunteers have:

  • Come to the study appointments on time. If you have a conflict, please call and reschedule.
  • You may be asked to take a medication or fill out forms at home. Please try to do this on schedule and to follow the study doctor’s instructions.
  • Always try to be honest when answering questions. If you had a headache, it is important for the study staff to know. If you don’t feel better, tell them. They want to know the truth.

Ask the study staff what other responsibilities you may have in the study.

Rights

Everyone who joins a clinical study has rights.  Ask the study staff about your rights in the study.

Read the Informed Consent Form – it will also tell you about your rights.

Some important rights are:

  • You do not have to join a study.
  • If you join, you can change your mind. You may leave a study at any time.
  • You have a right to ask questions and have them answered to your satisfaction.
  • You will not be charged for being in the study. Some studies reimburse volunteers for their time and transportation costs.
  • You have a right to confidentiality and privacy. Your name and contact information will not be on any study report.

You may have questions about a specific study, an injury that you think might be related to research, the instructions you received, or a payment. Ask the study doctor or staff all of your questions.

If you have questions about your rights, or complaints, you can also contact the IRB listed on your copy of the Informed Consent Form.

How do I learn more?

Below are links you can visit for more information.

General Information on clinical studies:

  • The Center for Information and Study on Clinical Research Participation is a nonprofit organization that works to help the public understand clinical research.
    www.ciscrp.org
  • Centerwatch is a company that works to educate patients about clinical research.
    http://www.centerwatch.com/

Lists of clinical research studies:

Most medical schools offer information on clinical studies.

You can also find information about research studies by searching the Web for the patient support groups that meet your specific needs.

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