Learn More About Clinical Trials

Find out more about the safe guards in place, what the various phases mean and what goes on in a study.

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Frequently Asked Questions

Connect people to the right clinical trials through proper education and intelligent matching.

The health of millions has been improved because of advances in science and technology, and the willingness of thousands of individuals like you to take part in clinical research. The role of volunteer subjects as partners in clinical research is crucial in the quest for knowledge that will improve the health of future generations. Without your help, the research studies at the Clinical Center cannot be accomplished.

The phase 1 study is used to learn the "maximum tolerated dose" of a drug that does not produce unacceptable side effects. Patient volunteers are followed primarily for side effects, and not for how the drug affects their disease. The first few volunteer subjects receive low doses of the trial drug to see how the drug is tolerated and to learn how it acts in the body. The next group of volunteer subjects receives larger amounts. Phase 1 studies typically offer little or no benefit to the volunteer subjects.

The phase 2 study involves a drug whose dose and side effects are well known. Many more volunteer subjects are tested, to define side effects, learn how it is used in the body, and learn how it helps the condition under study. Some volunteer subjects may benefit from a phase 2 study.

The phase 3 study compares the new drug against a commonly used drug. Some volunteer subjects will be given the new drug and some the commonly used drug. The trial is designed to find where the new drug fits in managing a particular condition. Determining the true benefit of a drug in a clinical trial is difficult.

Placebos are harmless, inactive substances made to look like the real medicine used in the clinical trial. Placebos allow the investigators to learn whether the medicine being given works better or no better than ordinary treatment. In many studies, there are successive time periods, with either the placebo or the real medicine. In order not to introduce bias, the patient, and sometimes the staff, are not told when or what the changes are. If a placebo is part of a study, you will always be informed in the consent form given to you before you agree to take part in the study. When you read the consent form, be sure that you understand what research approach is being used in the study you are entering.

Randomization is when two or more alternative treatments are selected by chance, not by choice. The treatment chosen is given with the highest level of professional care and expertise, and the results of each treatment are compared. Analyses are done at intervals during a trial, which may last years. As soon as one treatment is found to be definitely superior, the trial is stopped. In this way, the fewest number of patients receive the less beneficial treatment.

All medical care requires the patient’s consent. In some cases, you approve a care plan by getting a prescription filled or allowing blood to be drawn. This is called simple consent. The main purpose of the informed consent process is to communicate to you, the patient, the requirements of the study. You have the right to make decisions about your own health and medical conditions.

Informed consent for a clinical trial involves two parts: a document and a process.

Clinical Trial Informed Consent Document

The clinical trial informed consent document provides a summary of the trial, including its purpose, the treatment procedures and schedule, potential risks and benefits, and alternative treatments. It also explains your rights as a clinical trial participant. If you decide to enter the trial, you give your official consent by signing the document.

According to regulations in the United States, no informed consent document may say anything that asks – or seems to ask – you to give up your legal rights. It also may not include anything that releases – or appears to release – the investigator, doctor, sponsor or facility from liability if they are negligent or careless.

Clinical Trial Informed Consent Process

The clinical trial informed consent process provides you with ongoing explanations that will help you make educated decisions about whether to begin or continue participating in a trial. Before you make your decision, the research team will discuss the trial with you. If you decide to participate in a clinical trial, the researchers will continue to update you on any new information that may affect you. You will also have the opportunity to ask questions before, during and after the trial.

  • The chance to help society by contributing to medical research. Even if you don't directly benefit from the results of the clinical trial you take part in, the information gathered can help others and adds to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care.
  • Clinical trials are part of clinical research and at the heart of all medical advances. 
  • Clinical trials look at new ways to prevent, detect, or treat disease.
  • Participation is completely free.

The government has put in place strict guidelines to protect those who participate in clinical trials. Every study is approved and monitored by an Institutional Review Board (IRB). The IRB ensures that a trial is conducted ethically and that the rights of study participants are protected. The following section describes safeguards that protect the safety and rights of volunteer subjects. These safeguards include:
  • The Protocol Review Process
  • Informed Consent Procedures
  • The Patient Representative
  • The Patient Bill of Rights

Protocol review. As in any medical research facility, all new protocols produced at NIH must be approved by an institutional review board (IRB) before they can begin. The IRB, which consists of medical specialists, statisticians, nurses, social workers, and medical ethicists, is the advocate of the volunteer subject. The IRB will only approve protocols that address medically important questions in a scientific and responsible manner.

Informed consent. Your participation in any Clinical Center research protocol is voluntary. For every study in which you intend to participate, you will receive a document called "Consent to Participate in a Clinical Research Study" that explains the study in straightforward language. A member of the research team will discuss the protocol with you, explain its details, and answer your questions. Reading and understanding the protocol is your responsibility. You may discuss the protocol with family and friends. You will not be hurried into making a decision, and you will be asked to sign the document only after you understand the nature of the protocol and agree to the commitment. At any time after signing the protocol, you are free to change your mind and decide not to participate further. This means that you are free to withdraw from the study completely, or to refuse particular treatments or tests. Sometimes, however, this will make you ineligible to continue the study. If you are no longer eligible or no longer wish to continue the study, you will return to the care of the doctor who referred you to NIH.

Patient representative. The Patient Representative acts as a link between the patient and the hospital. The Patient Representative makes every effort to assure that patients are informed of their rights and responsibilities, and that they understand what the Clinical Center is, what it can offer, and how it operates. We realize that this setting is unique and may generate questions about the patient's role in the research process. As in any large and complex system, communication can be a problem and misunderstandings can occur. If any patient has an unanswered question or feels there is a problem they would like to discuss, they can call the Patient Representative.

Bill of Rights. Finally, whether you are a clinical research or a patient volunteer subject, you are protected by the Clinical Center Patients' Bill of Rights. This document is adapted from the one made by the American Hospital Association for use in all hospitals in the country. The bill of rights concerns the care you receive, privacy, confidentiality, and access to medical records.

Source: http://www.cc.nih.gov/participate/faqaboutcs.shtml


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