A Patients’ Guide to Clinical Research
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A Patients’ Guide to Clinical Research  

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A Patients’ Guide to Clinical Research

Interested in taking part in a clinical trial? Find out more about the process.

How Are Experimental Drugs Tested on Individuals?

Clinical testing of experimental drugs are normally done in phases. Each successive phase involves larger numbers of people.

Phase I Studies are primarily concerned with assessing the drug’s safety. Phase I Studies are done in a small number of healthy volunteers (20-100) who are usually paid for participating in the study. The study is designed to determine what happens to the drug in the human body – how it is absorbed, metabolized and excreted.

Phase II Studies are done once the drug has been shown to be safe in humans. The drug is being tested to determine if it works. Many Phase II Studies are also dose range finding studies (which dose works best). The second phase of testing may last from several months to two years, and will involve up to several hundred patients.

Phase III Studies involve the drug being tested on several hundred to several thousand patients. This large scale testing provides the FDA and the pharmaceutical company a thorough understanding of the drug’s effectiveness, benefits, and the range of possible adverse reactions. Phase III Studies typically last several years.

Phase IV or Post Marketing Studies involve several objectives. (1) They often compare a drug with other like drugs already on the market; (2) Studies are designed to monitor the drug’s long-term effectiveness and impact on the patient’s quality of life; (3) many studies are designed to determine the cost effectiveness of a drug therapy relative to other traditional therapies.

Who Pays for Clinical Research?
Funding for clinical research comes from both the federal government (through the National Institutes of Health) and private industry (pharmaceutical and biotech companies). The sponsor of the research hires the physicians, who may work in a wide variety of healthcare settings. The physicians conduct the clinical trial. The Medical Group is typically compensated on a per-patient basis. The medical care is often provided free to the patient.

What Questions Should I Ask if I Decide to Participate in a Clinical Trial?

How long will the trial last?

What treatments will be used and how?

What is the main purpose of the trial?

Are there any risks involved?

What are the possible benefits?

Who is sponsoring the trial?

Do I have to pay for any part of the trial?

What happens if I am harmed by the trial?

Can I opt to remain on this treatment, even after the termination of the trial?

Should I Participate in Clinical Research?

People participate in clinical research for a variety of reasons. People who volunteer for Phase II and Phase III trials can gain access to promising drugs long before these compounds are approved for the marketplace. They typically will get excellent care from the physicians during the course of the study. This care also may be free.

Patients Rights and Safety

Patients’ rights and safety are protected in two important ways. First, any physician awarded a research grant by a pharmaceutical company or the National Institutes of Health must obtain approval to conduct the study from the Institutional Review Board. The review board is charged with examining the study’s protocol to ensure the patient’s rights are protected, and that the study does not present unnecessary risks to the patient. Second, anyone participating in a clinical trial in the United States is required to sign an "informed consent" form. This form details the nature of the study, the risks involved, and what may happen to the patient in the study. The informed consent also tells the patient that they have the right to withdraw from the study at any time.

Patients considering participating in clinical research should speak to their physician(s). They should also seek to understand the credentials and experience of the individuals and the facility involved in conducting the study.

For More Information:
Email clinicalresearch@sentara.com to express your interest in clinical trials so that a clinical research representative can contact you.

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