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What are Clinical Trials?
Clinical trials are research studies that involve people. Carefully conducted clinical trials are the fastest and safest ways to find effective treatments and improve patients’ lives. Many treatments used today to fight cancer and cure disease are the direct result of past clinical trials.
Clinical trials are designed to answer questions about new ways to diagnose and treat cancer or manage side effects from existing treatments. These types of studies may seek to answer questions about new treatment methods or better ways to utilize existing treatments. They may involve testing of new drugs, innovative surgical techniques, or methods for improved delivery of radiation therapy or can include a combination of treatments.
Each clinical trial has specific criteria that patients must meet to be eligible to participate that include age, medical history, previous therapies received and the patient’s current health condition. The criteria for participating are designed to help ensure patient safety along with accurate and meaningful study results.
Clinical trials are conducted in phases – each phase has a specific purpose in helping physicians answer key questions:
Phase 1 Trials help researchers test new or experimental drugs or other treatments in a small group of people to find the best dosage or decide how the new treatment should be given and determine any side effects.
Phase 2 Trials involve a larger group of people to help determine how effective a new treatment is in fighting disease and further evaluate the reactions on the human body. Phase 2 clinical trials focus on evaluating safety and effectiveness of the medication being tested.
Phase 3 Trials involve several hundreds to thousands of people in comparing new treatments or a new use of a treatment with other standard treatments currently in use to fight the disease. Phase 3 clinical trials focus on evaluating the effectiveness and safety of the medication being tested in a large number of people.
Some therapies move on to Phase 4 Trials in order to further assess the long-term safety and effectiveness of new treatments.
Benefits and risks of participating in a clinical trial
Patients participating in clinical trials play a more active role in their own health care and gain access to new research treatments before they are widely available. Participants may be eligible to receive specialized medical care and treatment at no cost. Some studies’ participants may even receive payments to compensate them for their time and efforts devoted to the research study. Many participants get great satisfaction by knowing that they are helping others with a similar disease and are contributing to medical research.
There may also be some risks involved and your PHXMI Research team will explain in detail any risks associated with the specific clinical trial you may be considering taking part in, including any potential side effects, along with the requirements of the protocol.
In addition, some studies compare people receiving treatment to those who do not – so both you and your doctor may not know if you are actually receiving study medication and new therapies. In addition an experimental treatment may not prove effective.
Are clinical trials safe?
All clinical trials conducted in the United States must have government-registered protocols that include details of how the study will be carried out, characteristics of patient participants and precise schedules for the drugs, dosages, tests and procedures involved in the study. Before a clinical trial can take place, its protocols and techniques must be approved by Institutional Review Boards (IRBs).
An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. The IRB monitors the progress of the study throughout the clinical trial. Results of the trial are publicly reported at scientific meetings, to medical journals, and to various government agencies. However, the name and personal details of all study participants are kept in strict confidence in accordance with Federal law and never included in the reporting of trial results.