BACKGROUND: Clinical trials are biomedical or health-related research studies in human beings that follow a pre-defined protocol, according to clinicaltrials.gov.

There are two types of clinical trials: interventional and observational.

In an interventional study, an investigator assigns treatments to the participants and measures their outcome.

In an observational study, participants are simply observed and investigators measure their outcome.

Clinical trials involve doctors, nurses and social workers. In the beginning of the trial, they check the patient's health. Participants are given specific instructions and are monitored carefully during the trial. They are kept in touch even after the trial is complete.

PARTICIPANTS: Before joining a clinical trial, a participant must qualify. All clinical trials have guidelines and specific criteria to participate.

It's important to test drugs and medical products on the people they are meant to help. General criteria in clinical trials typically include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Sometimes healthy participants are needed, while other times particular illnesses are needed.

Informed consent is imperative for all participants of clinical trials. This is the process of doctors informing the patients of everything they need to know before and during the trial. Patients are fully educated on the purpose, duration, required procedures and key contacts of the trial.

BENEFITS VS. RISKS: According to clinicaltrials.gov, the benefits of participation include:

Playing an active role in your personal health care.

Gaining access to new research treatments before they are available to the public.

Obtaining expert medical care during the trial at leading health care facilities.

Helping society by contributing to medical research.

Risks that should be considered by all participants include:

Unpleasant, serious or even life-threatening side effects to experimental treatment.

The treatment may not be effective for the participant.

A longer time commitment than with typical treatment, due to observation and survey.

FOR MORE INFORMATION, PLEASE CONTACT:
Alliance for Human Research Protection
http://www.ahrp.org