Clinical research involves testing an investigational drug or device in humans. Each clinical trial must use
Phase I studies involve testing the investigational drug in a small number of healthy adult volunteers.
Before a new medicine can be sold the pharmaceutical company must perform rigorous testing to show
Clinical trials are sponsored by government agencies such as the National Institutes of Health (NIH); pharmaceutical companies;
A Principal Investigator (PI) is a person qualified by education, training, and experience to assume responsibility for the
Study Coordinators, who are often but not always nurses, are the “experts” of the protocol aside from the Principal Investigator.
People choose to take part in clinical trials for many reasons. Usually, they hope for benefits for themselves such as hope
Most all investigative treatments can cause side effects and other health risks. Side effects and health risks vary from patient
Several safeguards have been put into place that all companies must follow when conducting clinical trials.
A protocol is the set of rules that must be followed during a clinical trial. It describes what types of people may participate in the
Informed Consent is a freely given agreement on the part of a competent person in full possession of all available,
A placebo is an inactive substance (pill, liquid, or powder) that has no treatment value. It may be referred to as a “blank”
The term adverse event, as used in the context of clinical research, means any untoward medical occurrence in a patient
You should know as much as possible about the research study before you participate. It is important that you feel very
You should know as much as possible about the research study before you participate. It is important that you feel very
You should know as much as possible about the research study before you participate. It is important that you feel very
You will usually be paid for your time and travel while participating in a clinical study. Surgery, medical exams