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Clinical Trials Frequently Asked Questions

What is Clinical Research?

  • Clinical research includes studies that are done to answer a question about a medication, medical procedure or health behavior.
  • Not all clinical research involves medications. Some studies examine health behaviors, where medical providers want to learn more about how to speak with participants or improve health care and health information. Observational studies also do not test new medications.
  • Medical providers do research because they don't know for sure what will work best to help their patients, especially those patients with specific health needs.
  • Research is not the same as treatment:
    • Treatment involves drugs and procedures that have already been tested and approved by the FDA for a specific medical use with specific patients.
    • Research is done to test if new drugs are safe for general use, or to test if drugs that have already been approved can be used in a new way, or to better understand how health care providers can educate their patients and help to improve their health.

Why Is Research Important?

  • Research has led to important discoveries that make our lives better. Some examples are:
    • New drugs to treat cancer, diabetes, and other diseases
    • Vaccines
    • Ways to reduce risk of infection, such as prevention of HIV
    • Improved medical procedures
    • Better understanding of patient needs and education materials

What is a Clinical Trial?

Clinical trials test a drug, vaccine or medical device to see how well it works and how safe it is for the people taking it in a specific amount. Clinical trials can be done to understand new ways of preventing, finding, or treating a disease using study volunteers. During a clinical trial, volunteers work with nurses, doctors and other study staff to see if an experimental drug or therapy is safe and effective.

If you choose to take part in a clinical trial, you may help people to live longer, healthier lives. Medical research is important to help us understand how safe and effective new drugs are.

Why would I want to participate in a clinical trial?

You might want to participate in a clinical trial to take a more active role in their own health care, to gain access to new study medications before they are widely available, and/or to help others who are dealing with similar medical conditions.

What exactly will happen to me during a clinical trial?

The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as other health care professionals and staff. They check the health of the participant at the beginning of the trial, give specific explanations about your participation in the trial, monitor your progress throughout the study, and stay in touch with you after the trial is completed to ensure that you are doing well and to give you any important information about the study medication or results. Before you can participate in any research procedures, you will be asked to review a consent document with your doctor, ask any questions, and sign the consent to indicate that you understand the research procedures and agree to take part in the study.

You may leave the study at any time, even after you have signed the consent.

Will there be any unpleasant side effects?

Your study doctor and research team will work to ensure that side effects are minimal. However, since you may receive medicines that are still being tested, there is the possibility of unpleasant side effects. You will be informed in advance of receiving any medications the known risks on taking these medications, and your doctor will also let you know if any new risks are discovered while you are participating in the study.

There may also be risks of side effects from taking other medications in conjunction with the study drugs. All possible side effects will be reviewed by your study doctor with you before you decide to participate.

Will the research help me personally?

Because clinical trials often involve the testing of experimental drugs, there may be no benefit to you from participation. However, it is possible that you might experience direct benefits as well. Your health may be followed more closely than usual while you are on the study, which may help you feel better.

What other options do I have?

If you choose not to participate in a clinical trial, you may instead receive:

  • Prescription medications available to you
  • Experimental drugs on another clinical trial, if you qualify
  • No medications

The medical services available to you at UCLA and access to your health care provider will not change if do not choose to participate in a clinical trial.

Can I leave the study at any time?

Your participation in clinical trials is VOLUNTARY. If you choose not to participate, this decision will not affect your relationship with UCLA (or UCLA Medical Center), or your right to health care or other services to which you are otherwise entitled. If you decide to participate, you are free to withdraw your consent and discontinue participation at any time without prejudice to your future care at UCLA.

Will it cost me anything personally?

You will not have to pay for any medications being tested in the study. If your doctor decides that a different drug or drugs would work better for you, then you will have to pay for the different drugs. You or your insurance company will also have to pay for any additional medications not included in the study. You will not have to pay for study visits, exams, and lab tests needed for the study.

What are the benefits and risks of participating in a clinical trial?

Benefits

Clinical trials are sometimes the best way for participants to:

  • Take an active role in their own health care.
  • Gain access to new research medications before they are widely available.
  • Obtain expert medical care at leading health care facilities during the trial.
  • Help others by contributing to medical research.

Risks

However, there are risks to clinical trials:

  • There may be unpleasant, serious or even life-threatening side effects to experimental medications.
  • The experimental medications may not be effective for the participant.
  • The study may require more of your time and attention than would a non-study treatment, including trips to the clinic site, additional medications, or complex medication regimens.

How will my private information be protected?

Every effort will be made to keep your personal information confidential. This personal information may be disclosed if required by law. When the results of the research are published or discussed in conferences, no information will be included that would reveal your identity.

The only people who will know that you are a research subject are members of the research team and, if appropriate, your physicians and nurses. No information about you, or provided by you during the research, will be disclosed to others without your written permission, except if necessary to protect your rights or welfare (for example, if you are injured and need emergency care).

Any HIV antibody test results, viral load test results, or CD4 cell counts that include your personal identifying information will be reported to the Los Angeles County Department of Public Health as required by law.

What questions should I ask my study doctor before I decide to participate in a clinical trial?

  • What is the purpose of the study?
  • Who is going to be in the study?
  • Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
  • What kinds of tests 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?
  • Who will pay for the experimental 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 experimental treatment is working? Will results of the trials be provided to me?

What is a protocol?

A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to protect the health of the participants as well as to answer specific research questions. A protocol describes who may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. The goal of the protocol is to protect the well-being of study participants.

What is a placebo?

A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental medications are often compared with placebos to assess the experimental medications' effectiveness.

What are the phases of clinical trials?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

  • In Phase I trials, researchers test an experimental drug in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. Phase I trials are often conducted among healthy participants.
  • In Phase II trials, the experimental study drug is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
  • In Phase III trials, the experimental study drug is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used medications, and collect information that will allow the experimental drug to be used safely.