Subjects FAQs

What is a clinical trial?

A clinical trial is a research study that tests the effectiveness of a new medical treatment, drug or device using a limited number of patients, while complying with rules that protect patients' safety. Each trial enrolls patients with a certain disease or condition and a specific health status.

There are many different types of clinical trials. For example, there are trials that study prevention of disease, new investigational drugs, devices or treatments, and trials for screening and diagnostic techniques.

In a clinical trial, patients receive the most current medical care available from medical experts. Because clinical trials deal with very serious diseases, there's no guarantee that either the new treatment or the standard treatment will produce the hoped-for results.

Clinical trials are important for two reasons. First, they contribute to the knowledge of and fight against different medical conditions (i.e., osteoporosis, cancer, etc.). Secondly, they may benefit individual patients by helping them feel better, live longer or beat the disease.

Why join a clinical study?

People participate in clinical trials for a variety of reasons, but mainly they want to help themselves or help others. Volunteering for research studies can give patients access to promising new drugs long before they are available to the general public. Although there is always a chance that a new treatment will prove to be disappointing, there is reason to believe that it will be as good as, or better than, current treatments. Patients in these studies receive the benefit of medical specialization and expertise.

Patients considering participating in clinical research should talk about it with their doctors and medical caregivers. They should also ask about the credentials and experience of the individuals and the facility involved in the study.

How am I protected as a participant?

As a clinical trial participant under a doctor's supervision, you are protected by the same laws and ethics that normally regulate the medical profession. Informed consent helps protect you by making sure you have been given all the necessary information (including risks) regarding the trial. This helps you make the best, informed decision regarding whether to take part in the trial or not. The Food and Drug Administration (FDA) and Institutional Review Board's regulate clinical trials and advertisements to reduce misleading claims.

When you participate in a clinical trial your privacy is protected. Your medical records are confidential. The trial data that is provided to the pharmaceutical company and the FDA will not include your name or the names of other individuals participating in the study.

While it may not be possible to eliminate all risks associated with participation in a clinical trial, steps should be taken in all studies to reduce possible risks. These steps should include the development of a study protocol, or action plan, which acts like a "recipe" for conducting the trial. The protocol explains what will be done in the study, how it will be conducted, and why each part of the study is necessary. The same protocol is used by every doctor or research center taking part in the trial.

What are my responsibilities?

You have many responsibilities when you agree to participate in a clinical trial that may affect the effectiveness of your study. These responsibilities may include, but are not limited to, the following:

Carefully read the informed consent and ask your study doctor to clarify any information that you may not fully understand,
Inform the study doctor or the study staff of any changes in your health while you are in this study,
Follow all of the procedures outlined in the informed consent, including going to all study visits, taking medication as prescribed (if applicable), completing patient diaries (if applicable), etc.

What are my rights?

As a research subject, you have the following rights:

To be told the purpose of the research study, including why, when, where and for how long you will be involved,
To be told exactly what will happen to you and whether any of the procedures, drugs or devices differ from those that would be used in standard practice,
To be told about potential adverse side effects and/or potential discomforts for which you will be at risk by virtue of your participation in the research study,
To be told if you can realistically expect any benefit from participating in the study, and if so, what that benefit might be,
To be told what medical treatment is available if complications arise,
To be told if other alternative treatment choices exist, and how those treatments might be better or worse than being in the study,
To know how and to what extent your privacy will be protected,
To ask questions or express concerns at any time, whether before agreeing to participate, during the course of the study, or after it is completed,
To be free of pressure or undue influence when deciding if you want to participate or when debating whether to continue your participation in the study,
To refuse to participate in the study, or to change your mind and withdraw from the study at any time, without risking your future care or other benefits you would otherwise be entitled to receive,
To receive a copy of the signed consent form, the purpose of which is to document the potential risks and benefits of the study, in addition to explaining the goal of the study and what is expected of participants.

If at any time you feel your rights as a participant in human subjects' research have been violated, you should address your concern immediately with the investigator conducting the research or the Institutional Review Board (IRB) responsible for your study.

What is informed consent?

Informed consent is the process of understanding the risks and benefits of treatment. You as the patient have the right to make decisions about your own health and medical conditions.

Informed consent involves the use of an informed consent form (IC). This is the document that participants must sign before participating in a clinical research study. The informed consent document should be completely explained to the participant and should contain the following information:

The name of the clinical research study and its purpose
A statement that the study involves research
The length of time a study will last
A description of procedures that will be followed, and whether any of the procedures are experimental
A description of possible risks or discomforts associated with the study
A description of any benefits to you or to others, if any, that are reasonably expected
A description of alternative therapies, if any, to participation in the study you should consider
A description of the level of confidentiality that will be applied to your personal information and who may have access to your records
Explanation as to whether compensation or medical treatments are available for participation in the study, including study-related injuries
Explanation of whom to contact with questions concerning the study or a research-related injury (usually the clinical investigator), and questions concerning research participation rights (usually the IRB)
A statement that participation in the study is voluntary and that a choice not to participate or to discontinue participation, will not result in any loss of benefits or penalty to you

What is an Investigator?

An investigator is any person who actually conducts a clinical trial. This would be the person who will supervise the administration of the study drug or device. This person may be a doctor or other healthcare professional. The investigator may be called the clinical investigator, the principal investigator, or the study doctor. The investigator may be assisted by a research team or study staff that includes other doctors, nurses, study coordinators, and other healthcare professionals.

While this investigator is responsible for carrying out the study requirements as described in the study protocol or study plan, it is important that you maintain contact with your primary health care provider (your regular doctor0 and other specialists before, during, and after your participation in the study to make sure that you have the best information about your health care decisions and to make sure that other treatment medications you are taking do not interfere with your ability to participate in the study.

What is the FDA?

The Food and Drug Administration (FDA) is the government agency that sets guidelines on the manufacture, testing, and use of drugs and medical devices. All drugs and medical devices must be approved by the FDA before they can be used by the general public.

Why are clinical research studies done?

Medical science is always looking for better or new solutions to treat diseases. Before a new procedure, device, or drug can be used as a treatment it must be tested for effectiveness and safety. Most likely, every doctor-prescribed medication that you use was first tested in a clinical research study. Clinical trials are key to improving medicine for all patients. Without clinical research,the medications and/or medical devices available for treating all diseases would not change or improve.

Although much information is gained by laboratory and animal studies, new treatments must undergo controlled testing in human subjects because their safety and effectiveness may be different in humans. They may also differ from one person to the next.

The Food and Drug Administration (FDA) requires clinical research before it can approve a new treatment as safe and effective for public use. Clinical research is the only accurate way to discover how a treatment works in human subjects.

How are clinical research studies organized?

Clinical studies are performed in four phases. They each look at different questions:

Phase I studies include participants taking a study drug for the first time. Only a small number of people (usually between 20 and 80) are part of Phase I studies. Phase I studies focus on the safety of the study drug and how much of it that may be safe to take in future studies.
Phase II studies take a look at the effect of the study drug on the disease and continue to study its safety. Usually between 100 and 300 subjects participate in a Phase II study.
Phase III studies are done to understand the effectiveness and safety of the study drug or treatment. Phase III studies include large groups of people which can range from 1,000 to 3,000 people or even more. This allows physicians to gain a thorough understanding of the study drug.
Phase IV studies are performed with a drug or treatment that can be prescribed for patients. Phase IV studies are done for many reasons, which include finding out more about the safety of the drug and how it works for other diseases.

When should I contact the IRB?

If you have a question about your rights as a study participant, you should contact the IRB. If you have been injured as a result of the research study, contact your study physician.

Where can I find out more about clinical research studies?

See Helpful Links