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Frequently Asked Questions About Clinical Trials
—Reviewed by Alexandra Lee, RN, CCRC
What is a clinical trial?
What is the informed consent document?
How should I decide whether to participate in a clinical trial?
What is a screening visit?
What are the benefits of being in a clinical trial, and are there any risks?
Can I stop participating in a clinical trial after I have started?
What is a placebo?
What is a blinded trial?
After a blinded trial, will I be able to find out which treatment I recieved?
What is an open trial?
What is a sponsor?
What is an IRB, and what does it do?
What is the NIH, and what does it do?
What is the FDA, and what does it do?
What is a Phase I trial?
What is a Phase II trial?
What is a Phase III trial?
What is a Phase IV trial?
Will I be paid to participate in a clinical trial?
Will I receive free health care by participating in a clinical trial?
Will I need to have extra tests or office visits?
How will my identity and my personal information be protected?
Will I be able to find out the results of the clinical trial?
Clinical trials are research studies that evaluate new methods of treatment or diagnosis of a disease or condition. The purpose of a clinical trial is to ensure both the safety and effectiveness of these methods. The clinical trial process is required for all drugs, devices, and procedures seeking government approval for mainstream use.
The informed consent document serves to confirm a patient’s willingness to participate voluntarily in a particular study. The document spells out the study's purpose, procedures, and duration, the risks and potential benefits of study participation, the study participants' rights and obligations, and study contact information.
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 a copy of the study's informed consent document. 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 be given the option to sign the informed consent document and undergo any necessary screening procedures.
Before entering most clinical trials, a potential participant is required to attend a screening visit to confirm whether he or she is eligible for that particular study. If a participant meets a set of predetermined criteria, he or she can proceed with that clinical trial.
There may or may not be any direct benefits to your health for participating in a clinical trial. You should consider the risks of a clinical trial carefully and discuss any concerns with your doctor. The potential risks of a new treatment are listed in the informed consent document, which you should carefully review with family, friends, and your own doctor before agreeing to sign it.
Yes. The informed consent document is not a legal contract, and every participant has the right to withdraw from any clinical trial at any time for any reason. If you choose to withdraw from a study, kindly notify the study staff so that you can be withdrawn safely and appropriately.
A placebo is a "pretend" medication composed of an inactive substance (that does nothing to the body), used for the purpose of comparing its effects to those of the study medication.
A blinded trial is a study in which either the study participants or the study staff—or both (in a double-blind trial)— are not told which of two or more alternate therapies (or placebo) is being administered. This reason for conducting a blinded trial is to ensure that expectations do not affect the study's outcome. Blinding is usually accomplished by a process called randomization (like the flip of a coin). In a drug study, for example, randomization might determine whether particular participants are to take the active study medication or a neutral placebo.
Often study participants are able to find out which treatment they received in a blinded trial. However, this is usually not until all participants at all study sites have completed the study, and the results have been reviewed by the FDA. If there is an emergency while you are on the study treatment, and your doctor needs to know which treatment you are receiving, he or she can find out. This is called "breaking the blind." Once the blind is broken, you may need to be removed from the study. If this happens, the study doctor will still need to follow up with you for safety.
In an open trial, all parties (participants and study staff) know the therapy that the participant is receiving.
A sponsor is an individual or organization that takes responsibility for initiating, organizing, and managing a clinical trial. A sponsor is often a pharmaceutical company or governmental agency (such as the NIH).
An Institutional Review Board (IRB) is a committee of medical and medical-ethics professionals who review, approve, and monitor proposed clinical trials and in particular ensure that the rights and safety of study participants ("human subjects") will be given highest priority. The IRB is responsible for approving all study materials and procedures, including the informed consent document and study recruitment materials. Furthermore, the IRB has to be notified of any serious change in a participant's health status or any major deviation from the initial description of the study procedures.
The National Institutes of Health (NIH) is the agency of the United States Department of Health and Human Services that oversees and is ultimately responsible for biomedical and health-related research.
The Food and Drug Administration (FDA) is the agency of the United States Department of Health and Human Services responsible for regulating and supervising the safety of, among other things, foods, dietary supplements, prescription and nonprescription medication, vaccines, biopharmaceuticals, and medical devices. The FDA also oversees investigational drugs in the process of approval for use in clinical trials.
A Phase I clinical trial, typically involving a small (20-50) group of participants, establishes the safety and tolerability of the new treatment. All phases of clinical trials (I, II, III, IV) require IRB approval before proceeding.
Once the safety of the study treatment has been confirmed in a Phase I trial, a Phase II trial may be conducted with a larger group of participants (up to a few hundred) to assess treatment effectiveness as well as to continue Phase I safety assessments.
Once a Phase II trial has demonstrated the effectiveness of the study treatment and further confirmed its safety, a Phase III trial involving hundreds or even thousands of participants may be conducted—typically simultaneously at several academic healthcare centers (in what is called a muticenter trial)—to further establish the treatment's safety and efficacy.
A Phase IV trial, generally known as a postmarketing trial, involves the safety surveillance and ongoing technical support of a treatment after the FDA has approved its use in the general population.
Some clinical trials offer reimbursement for time and travel while participating in a trial. This reimbursement is not meant to pay you to be in the study. The informed consent will discuss any reimbursements under the section called "Compensation."
Some clinical trials offer health care at no cost while participating in a trial. The informed consent will discuss this under the section called "Costs/Reimbursements." Your participation in a clinical trial should not be viewed as a substitute for treatment of a condition or disease.
Some clinical trials will require extra tests and/or office visits. The informed consent will discuss this under the section called "Subject Participation" and/or "Description of Research." Please discuss this with the researcher obtaining your informed consent.
Private information about you that identifies you may be used or shared for the purposes of a research project. The consent form describes how your information will be used and shared in the research, and the ways in which the researchers will safeguard your privacy and confidentiality.
Usually, the results about the effectiveness of a study treatment are shared with study participants after the study is complete and the results have been reviewed by the FDA. However, if the researchers discover any new side effects or risks during the course of the study, you would be notified. You could then decide whether to continue participating in the study, based on the new information.
- National Institute of Health. (n.d.). Glossary. Retrieved January 2010 from ClinicalTrials.Gov
- National Institute of Health. (n.d.). Understanding Clinical Trials. Retrieved January 2010 from ClinicalTrials.Gov
- The Association of Clinical Research Professionals. (1998). Federal Regulations and Guidelines Reference Manual. ACRP.
- NYU School of Medicine Institutional Review Board Website for Volunteers. http://irb.med.nyu.edu/for-research-volunteers/information-research-volunteers