Experimental Drug Therapies

This blog is designed to cover the current controversy regarding experimental drug therapies. New drugs that are developed must go through a safety process. However, there are "compassionate use" exceptions made for seriously ill patients when no other treatments are effective. As future nurses/health-care workers, we need to be educated on this issue to be able to keep up with advancing medical science to be better advocates for our patients.

We hope that by reading this blog, we can provide you information on both sides of the issue so that you can form your own opinion on the topic. We also invite you to participate in our discussion by commenting on any of the posts!

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We are a group of pharmacology pre-nursing students from the University of Texas at Arlington. This blog was created for our friends, family and health care providers on the education of experimental drug therapies and their impact on consumers.

This is an important issue to consumers because every drug that is created and approved by the FDA has to go through experimental drug testing. The integrity of the drug testing directly effects the public. This is an important issue to health care providers because it is important to know the data behind the drugs we administer and their possible side effects.

Experimental drug therapies can provide some hope to some who are ill with terminal illnesses, but it faces many problems:

1. Many may try to exploit the ill, who are already vulnerable, with "promises" of a cure.
2. Some may try and "buy" their spot in clinical trials.
3. Safety/efficacy may not be well known.

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UTA Pharmacology

Authors

Max Flores, Stacie Guinn, Ryan Wencl

Experimental Drug Terminology

CONTROL GROUP: The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

DOUBLE-BLIND STUDY: A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study.

DRUG-DRUG INTERACTION: A modification of the effect of a drug when administered with another drug. The effect may be an increase or a decrease in the action of either substance, or it may be an adverse effect that is not normally associated with either drug.

EXPERIMENTAL DRUG: A drug that is not FDA licensed for use in humans, or as a treatment for a particular condition

INFORMED CONSENT: The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study.

OFF-LABEL USE: A drug prescribed for conditions other than those approved by the FDA.

PLACEBO: A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness

PLACEBO EFFECT: A physical or emotional change, occurring after a substance is taken or administered, that is not the result of any special property of the substance. The change may be beneficial, reflecting the expectations of the participant and, often, the expectations of the person giving the substance.

RANDOMIZATION:A method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. From what is known at the time, any one of the treatments chosen could be of benefit to the participan.

SIDE EFFECTS:Any undesired actions or effects of a drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects

Experimental Drug Therapies

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