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Frequently Asked Questions About Clinical Trials

Reviewed by Brianne Goodwin, RN

What is a clinical trial?

A clinical trial is a research study that evaluates new methods of treatment or diagnosis of a disease or condition. The purpose of a clinical trial is to evaluate the safety and the effectiveness of these methods. This is the required pathway for all drugs and devices to gain approval of governing authorities and become available for mainstream use.

What is the informed consent document?

The informed consentdocument serves to confirm the participant’s willingness to participate voluntarily in the study. Informed consent is also a good reference for the participant, as it contains information on scheduling of visits, types of procedures, possible risks and benefits, rights of the participants, the purpose of the study and study contact information.

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How should I decide whether to participate in a clinical trial?

First, contact the study personnel to see whether you qualify and to get a better idea about the clinical trial you are interested in. After that, ask for an informed consent document to be sent to you. You should review the informed consent document to inform yourself thoroughly of the purpose of the study and the possible benefits and/or risks to you. It is also recommended that you consult your primary healthcare provider regarding participation. Finally, if you decide you would like to participate, you may contact study personnel to schedule your first visit. It is at this visit that you will sign the informed consent document and undergo any necessary screening procedures.

What is a screening visit?

In most studies, before participating in a clinical trial, participants have to go through a screening visit that will confirm whether the subject is eligible for that particular study. If a participant meets a set of predetermined criteria, he or she can proceed with a clinical trial.

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What are the benefits of being in a clinical trial, and are there any risks?

There may or may not be any direct benefits to your health for participating in a clinical trial. One should consider risks of a clinical trial carefully. A list of risks is found in the informed consent document. This is another reason why participants should carefully review the consent form. Please note that participation in a clinical trial should not be viewed as a substitute for treatment of a condition or disease.

Can I stop participating in a clinical trial after I have started?

Yes, the participant has the right to withdraw from the trial at any time for any reason. It is advisable to notify the study staff, so that the participant can be withdrawn safely and appropriately.

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What is a placebo?

A placebo is a ‘pretend’ medication composed of an inactive substance (that doesn’t do anything to the body), used for the purpose of comparing its effects to those of the real medication.

What is a blinded trial?

Blinding refers to when it is not known what therapy the patient is on. A subject’s therapy is usually done by a process called randomization (like the flip of a coin). He or she could be taking active study medication or a placebo. A single-blind trial is when the participant doesn’t know what therapy they are taking. In a double-blind trial, neither the subject or the study staff know what therapy is being given.

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What is an open-label trial?

An open-label trial refers to a study where all parties know the therapy that the patient is receiving.

What is a sponsor?

A sponsor is an individual or organization which takes responsibility for initiation, organization and management of clinical trial. It is often a pharmaceutical company, or governmental agency (such as the NIH).

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What does the IRB do?

IRB, or Institutional Review Board, serves as an ethics committee that approves studies and protects rights and safety of human subjects. Before a study can proceed, it has to be approved by an IRB, to ensure that the study is following ethical standards and to maximize subject safety. The IRB is responsible for approving all of the materials that have to do with the study, including the informed consent document and advertisements. Furthermore, the IRB has to be notified of any serious change in a subject’s health status or any major deviation from the initial description of the study procedures.

What is NIH?

NIH stands for National Institute of Health, and is a U.S. governmental agency that is responsible for biomedical and health related research.

What does the FDA do?

The Food and Drug Administration is the governmental agency that regulates the approval and sale of food, drugs and cosmetics. The FDA also oversees investigational drugs in the process of approval.

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What is a Phase I trial?

A Phase I trial is aimed at establishing safety and it enrolls a small number of volunteers.

What is a Phase II trial?

At this stage, the clinical trial focuses for the first time on efficacy of the medication or device in a given condition. It also further looks to establish safety.

What is a Phase III trial?

At this stage, the number of subjects is expanded to a larger number of patients and specific populations. The purpose of these studies is to further determine efficacy and safety.

What is a Phase IV trial?

A Phase IV trial is generally know as a post-marketing study, after a drug has already been approved by the FDA.

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References

  • National Institute of Health. (n.d.). Glossary. Retrieved September 2008, from ClinicalTrials.Gov
  • National Institute of Health. (n.d.). Understanding Clinical Trials. Retrieved September 2008, from ClinicalTrials.Gov
  • The Association of Clinical Research Professionals. (1998). Federal Regulations and Guidelines Reference Manual. ACRP.