Clinical Trials

1 What are Clinical Trials?

Clinical trials are in use to test cancer therapies, the safety and efficacy of new drugs, treatments for cardiovascular disease and a number of other conditions.

The U.S. National Institutes of Health (NIH) defines a clinical trial as "a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (such as drugs, treatments, devices, or new ways of using known drugs, treatments, or devices)."

Every clinical trial in the U.S. must pre-approve an Institutional Review Board (IRB) consisting of physicians, statisticians, researchers, patient advocates and others and ensuring that the trial is ethical and protects patients' rights. It must follow a protocol that describes what types of people may participate in the trial (based on age, gender, underlying disease, health history, or other factors), outlines the exact the schedule of tests, procedures, medications, and/or dosages involved in the trial and specifies the length of the study.

Clinical trials can be funded and sponsored by:

  • Pharmaceutical or biotechnology companies
  • Hospitals
  • Institutions
  • Physicians
  • Government agencies
  • Advocacy groups
  • Other organizations

Some clinical trials offer monetary compensation for participants and some trials may offer their participants free health care that is related to the condition being studied or screening examinations.

Clinical trials can be carried out in different locations, including hospitals, clinics, individual physician practices, university health centers, or community health centers.

Clinical trials have a few phases. The first phase evaluates the safety and potential side effects of a drug or treatment to a small group of people (20-80) while a second phase evaluates it to a larger group of 100-300 people and a third phase to even more people (1,000-3,000).

Post-marketing studies are carried out in phase four to collect more information about the optimal use of the drug or treatment and to further evaluate its side effects.

The patient’s doctor can offer information about clinical trials that are currently underway for the specific condition of a patient.

After learning about the trial and having had the opportunity to ask questions and before participating in a clinical trial, the patient must give an informed consent – a document that describes the rights of the participants, as well as gives details of the study and names of the investigators who are conducting the study and contact information for these people.

An informed consent document is not a legal contract that requires participation in a study for the length of a study, so a participant is free to leave a clinical trial at any time. The patient must be fully aware of all the details, risks vs. benefits, and expectations of the trial before agreeing to participate.

Clinical trials are required to maintain strict patient privacy and the name of the patient must not be published anywhere that data about the trial are published or included in any publicly available information.

When a clinical trial is over, the patient will continue to receive care through their primary provider and any other practitioners required for their condition.

There are lots of benefits of clinical trials: from helping others by aiding the process of knowledge acquisition and development of enhanced treatments, being cared for by leading health-care teams in a given field, and in some cases, receiving access to new treatments before they are approved.

The risks include side effects of drugs and risks of any procedures that may be performed.

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