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Clinical Trials Defined

The jargon of clinical trials can be confusing or tough to understand.  In keeping with the spirit of knowing as much as possible to make an informed decision, here is a glossary of common clinical trial terms which may not be so common to you.

  • Clinical Investigator
    The researcher who is in charge of carrying out a clinical trialís protocol.


  • Control Group
    A group of patients that receives standard treatment instead of the drug being tested.  Results in the control group and those patients receiving the newly developed treatments are compared.  If there is no standard treatment yet, then the control group receives no treatment.


  • Double Blind Study
    An experiment where neither the patient nor the attending physician knows whether the patient is getting one or another drug or dose.  In blind studies, only the patient does not know, preventing personal bias from influencing reactions and study results.
  • Informed Consent
    This is a dialogue between a potential patient and the clinical investigators where all risks, benefits, procedures, and expectations of a clinical trial are discussed. The FDA requires all patients to sign an informed consent form before participating in a trial.
  • Institutional Review Board (IRB)
    A group of health professionals from the trial institution and members of the local community.  This board is responsible for seeing that there is no unreasonable risk to the patient, and that the informed consent process accurately informs the patient about his or her role in the study.
  • Investigational Treatment
    This is the drug or device being tested during a clinical trial.
  • Placebo
    An inactive substance which resembles the medication being tested, and that is given for psychological effect or as a control in evaluating a medicine believed to be active.
  • Protocol
    A detailed plan carefully designed by a clinical trial sponsor.  It sets strict guidelines for a trial and usually involves several different trial locations.
  • Risk/Benefit Ratio
    The relation between the risks and benefits of a given treatment or procedure.
  • Staging
    Methods used to establish the extent of a patientís disease.
  • Standard Treatment
    A treatment, currently in wide use, and approved by the FDA for a particular disease or illness.  In some trials involving new investigational treatments, there may be no pre-existing treatment at all.  In these cases, the lack of any treatment is itself considered the standard treatment.   Generally speaking, the hope is that investigational treatment will be safer or more effective than the standard treat

     


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