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What are the phases of a clinical trial?

Wednesday, April 22nd, 2009

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions: Saltzer Clinical Research participates in Phase II – IV trials. The trial protocols are designed by the sponsoring pharmaceutical company, then distributed to sites like ours to recruit subjects for them. The trials are closely monitored to ensure that the physicians are following the protocol exactly as written and make sure the data we report is accurate. Physicians (Principal Investigators) and study coordinators are required to report all adverse events that occur while a person is on a study whether or not it is related to the drug or not.

In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80), for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety in the population of patients it is intended to treat.

In Phase III trials, the experimental study drug or treatment is given to an even larger groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

In Phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use or to compare two FDA approved drugs to each other. After a drug is FDA approved, it is still studied in Phase IV trials.

More information on Clinical Research

Friday, February 13th, 2009

What is Informed Consent?

Informed consent is a document that you are asked to read and sign that explains:

  • Why the study is being done
  • What you can expect
  • Possible side effect
  • Risks and benefits
  • Who will see your information
  • How the information is kept confidential
  • Who is sponsoring the trial
  • How to quit if you want to
  • Who to contact with questions
  • Details on all procedures and tests
  • Patient rights
  • Who can be in a study?

    Each study has different requirements for participants such as age, gender, or medical condition. The research team will look at your medical history and study requirements to find out if you are eligible. Most studies involve more tests and visits than you would normally have for an illness or condition. There is no cost to participate, in fact you get paid at each study visit.

    Why participate?

    Saltzer is one of the few sites in Idaho paticipating in studies. The research department is staffed with experienced trial coordinators and physicians. Join a trial today and you will not only be helping researcher find new treatments, but will also learn new information about your condition and receive study-related medicines and exams at no cost.

    For more information on current research trials, please click here.

    What is a Clinical Research Study?

    Friday, February 13th, 2009

    A clinical trial is a research study that involved people who volunteer to receive investigational treatments under the supervision of the physician conducting the trial for the pharmaceutical company. It is through these trials that the investigational medications are tested for safety and effectiveness in the population of patients the medicine is intended to treat.

    Other times studies are done to compare one drug to another or to test its long term effectiveness. It is important to know that once the medication has been sent to the physician for study, it has already been through several preliminary studies. Prior to agreeing to participate in any trial you are asked to sign an informed consent form. The FDA reviews all clinical trial activity and independent review boards exist to make sure your rights are protected and that you are not exposed to unnecessary risks. A volunteer has the right to leave the study at any time and for any reason.

    For more information on current research trials, please click here.

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