Clinical trials are scientific studies involving human volunteers or participants, designed to assess safety and efficacy of new treatments and add to medical knowledge.
A Clinical Trial is conducted to find better ways to prevent, diagnose and treat diseases. Clinical Trials are one of the final stages in a long and careful research and development process to find new and better health care solutions. Trials of new potential treatments may show which medical approaches are better for different illnesses or groups of people.
All medicine and treatments must be tested in clinical research studies before they can be approved by regulatory authorities and made available for use. Without clinical trials and clinical trial participants there would be no new medicines or treatments.
All trials must meet strict Ministry of Health guidelines, they must also be approved and monitored by the New Zealand Ethics Committee and other governing bodies for the duration of the trial to ensure all participants are appropriately treated.
All new drugs for treatment in humans must pass through several phases of clinical trials.
Testing on a small number of healthy volunteers to check safety, efficacy and tolerability and determine side effects.
Establishing the efficacy of the drug, usually against a placebo, on patients with the condition the medication is designed to treat.
These trials involve large numbers of participants to assess treatment efficacy, effectiveness and safety.
Once a treatment is on the market, further trials are conducted to compare trials, assure long-term safety and effectiveness of the drug.
CGM Research Trust pays careful attention to the needs of participants, throughout the course of the study providing services such as transportation, 24 hours availability of study staff, arrangement of referrals to other doctors and support groups and ensuring continuity of care.