Understanding Clinical Trials
A clinical trial is the testing of a product (drug) on a human subject. Before the product is tested on humans, years of chemical and animal testing takes place. During a clinical trial, subjects are closely monitored. At the end of the trial, an application is filed with the Food and Drug Administration (FDA). If the FDA finds that the manufacturer has proven the technology to be safe and effective for the requested indication, the drug can be marketed. The entire clinical trial process can take about 10 years and millions of dollars to complete.
Informed consent is the process in which the potential participants learn key facts about a clinical trial to determine if participation is appropriate. Informed consent is a continuing process throughout the study providing information to the participant as required.
The risk of participating in clinical trials is outlined in the informed consent. It should be noted that that there may be unpleasant, serious or life threatening side effects during the trial, or the drug treatment could prove to be ineffective.
The protocol treatment may require more of the participant's time than would a non-protocol treatment, leading to more treatments, hospital stays, trips to the study site or complex dose requirements.
Paying For Clinical Trials
Funding for clinical trials may come from the federal government by way of the National Institutes of Health as well as private industry such as pharmaceutical and biotechnology companies. Generally, a sponsor of the research will hire doctors from a wide variety of healthcare specialties to conduct the trials. Doctors are typically paid on a per-patient basis. Medical care to the participant is usually free and sometimes participants are paid a small stipend.