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Clinical Trials

People volunteer for clinical trials for different reasons. Some people feel the need to help advance science by participating in a research trial, while others are looking for different therapies or new therapies that might help them. Perhaps someone does not have medical insurance to cover their health care. Whatever the reason, participating in a trial can be a rewarding personal experience.

Before you make the decision to volunteer, it helps to understand what a clinical research trial is, and to ask your physician and your research center’s staff any questions you may have before volunteering.

What is a Clinical Trial?

A clinical research trial is a carefully designed study supervised by physicians and other research professionals where patients volunteer to receive investigational treatments that have not yet been approved by the FDA. Studies are conducted for a number of reasons:

  • For a new drug therapy
  • For a new form of an already approved medication (for example, instead of a pill, they want to test the liquid form of the drug)
  • For the treatment of a different disease with an already approved medication
  • For marketing purposes to give patients access to newly approved therapies

The Food and Drug Administration (FDA) requires that drug companies prove that the investigational treatment works. In order to do so, the patients on an investigational treatment are often compared to patients on a sugar pill (“placebo”). Scientists compare the results and tabulate all of the data to determine if the investigational product works.

Don’t think, however, that a drug only goes through one clinical trial to determine if it works. The FDA requires a number of different tests to determine the safety and effectiveness of a medication in three different phases.

Clinical Trial Phases

  • A Phase I clinical trial is usually conducted in a small number of healthy volunteers (20 to 80) and studies the drug’s safety profile, including the safe dosage range.
  • Phase II clinical trials involve a slightly larger number of volunteer patients, usually between 100 to 300, and are used to assess the drug’s effectiveness.
  • Phase III clinical trials usually involve 1,000 to 3,000 patients. These studies confirm that the drug works and identify any side effects for long-term use in three different phases.

Safety

Each and every study must be reviewed by an independent committee. This committee is responsible for ensuring your rights as a patient are fully protected and that you are not exposed to unnecessary risk. Before you agree to participate in a clinical study, the investigator or nurse will have you sign a form (informed consent) explaining to you the risks and benefits involved in the study and will be there to answer any questions you may have. Questions are encouraged by the research staff and physician.

Expectations

After signing the consent form, you may receive the following at no cost:

  • A physical exam
  • A medical history
  • Study medication
  • Laboratory tests
  • Study procedures as necessary

Your participation is valued and extremely important. By participating in a clinical trial, you will be taking a part in helping to advance medical science in bringing new and important drug therapies to help fight diseases and illnesses.

You will receive excellent medical attention during a clinical trial — your safety is the number one priority. Therefore, it is very important that you take all of the medication as prescribed and go to all scheduled visits. Also, you should answer questions that the investigator may ask in regard to how you feel and whether you have been taking your medication at scheduled times. The investigator must record any symptoms no matter how minor they may seem. If the medication has not been taken correctly, you should not be afraid to tell the investigator or research staff. Your input is valuable and important.

*It is important to remember that you have the right to leave the study at any and for any reason.

Research Contact: 740-441-3990

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