Volunteers

All medicines in use today must be proven safe and effective in clinical trials before they can be made available for widespread use within the community. Early phase clinical trials are a vital step in this development process and it is these trials that are conducted at Q-Pharm. Q-Pharm conducts the following types of clinical trials:

Phase 1 trials - normally conducted in healthy volunteers.
These trials are designed to test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II trials - conducted to evaluate the effectiveness of the drug in patients with the disease or condition under study. Phase II trials usually involve no more than several hundred subjects
Bioequivalence trials - used to determine if a new generic medicine is equivalent to the currently approved medicine

The clinical trials performed at Q-Pharm require healthy volunteers or patients with specific medical conditions. We rely on voluntary community participation in this process, and are grateful for the time and effort offered by our trial participants, without whom new and sometimes life-saving medicines would not become available to the wider community.

All studies at Q-Pharm are conducted under Australian and International guidelines for medical research under the approval of a Human Research Ethics Committee that complies with the strict guidelines as set by the National Health and Medical Research Council. Participation in a trial is dependent on fulfilment of trial specific criteria and overseas visitors require appropriate visas for trial participation.