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DNP Guide: Clinical Trials

ClinicalTrials.gov

http://clinicaltrials.gov/ct2/html/ct3/images/ct.gov-logo.png

Registry of federally and privately supported clinical trials conducted in the United States and around the world.

ClinicalTrials.gov gives you information about a trial's purpose, who many participate, locations, and phone numbers for more details.

What are Clinical Trails?

Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.

Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can participate. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.

In the United States, an independent committee of physicians, statisticians and members of the community must approve and monitor the protocol. They make sure that the risks are small and are worth the potential benefits.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

What are the Phases in a cllinical trial?

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

  • Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
  • Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

What is Informed Consent?

An essential component of initiating a clinical trial is to recruit study subjects following procedures using a signed document called informed consent.

Informed consent is a legally-defined process of a person being told about key facts involved in a clinical trial before deciding whether or not to participate. To fully describe participation to a candidate subject, the doctors and nurses involved in the trial explain the details of the study using terms the person will understand. Foreign language translation is provided if the participant's native language is not the same as the study protocol.

The research team provides an informed consent document that includes trial details, such as its purpose, duration, required procedures, risks, potential benefits and key contacts. The participant then decides whether or not to sign the document in agreement. Informed consent is not an immutable contract, as the participant can withdraw at any time without penalty.