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Most new drugs being studied today are being developed in an effort to find better or safer medications. Study volunteers usually receive expensive medicines, exams, x-rays, and electrocardiograms at no cost. They also usually receive a stipend for travel and inconvenience.
How a Drug Comes to Market
All drugs must first undergo extensive experiments with human cells and animals, testing for toxicity. If they are found to be safe, they are presented to the FDA for approval to begin testing in humans.
Testing is done in three phases.
Phase I studies are primarily concerned with testing the drug's safety.
Phase II studies test for effectiveness with patients randomly assigned to a "control" group receiving treatment either with an approved drug or a placebo (sugar pill), and compared to the group receiving the study medication. Neither the patient nor the physician knows which group the patient has been assigned to ("double-binded").
Phase III tests thousands of patients, providing a more thorough understanding of the drug's effectiveness, benefits, and range of adverse reactions. These are also randomized and double-blinded trials.
Once a phase III study is successfully completed, a pharmaceutical company can request FDA approval of their study medication.
What Constitutes a Good Investigational Site?
A good study site should have the following:
- Trained personnel with knowledge of the study protocol and ability to answer any questions.
- Professional attitude: Careful, non-rushed consenting process answering all questions to your satisfaction.
Dos and Don'ts
- Do always talk with the physician investigator before starting the study to ask any questions or address any concerns.
- Do have a feeling of confidence that the staff places your interests and well being above that of the study itself and never feel you are being pressured or coerced into doing the study.
- Don't get involved in a study just for the money if it doesn't otherwise make sense to you.
- Do read what you sign carefully and ask questions.
- Do understand the potential side-effects. Placebo is often used in many trials; make sure you understand how this might affect your condition.
SUMMARY
Investigational trials, when conducted properly, are usually very satisfying, safe and educational for study patients. Patients point to an increased knowledge of their disease process as a benefit, and can receive investigational medications and treatments that are not yet available to others.
John E. Ervin, MD, FACP, FACR
The Center for Pharmaceutical Research
816-943-0770
Kansas City, MO
Visit our website for further information:
www.cprkc.com
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