Pharmaceuticals and Other Treatments
Insight provides a range of consulting and training services for designing, conducting and analyzing studies of pharmaceuticals and other treatments.
A standard study design involves comparing the disease progression for patients who receive a novel treatment versus that for patients receiving a standard or placebo treatment. Pharmaceutical studies are generally classified as:
Phase I - testing a new treatment with a small group of people (eg. 20-80) to evaluate safety (dosage range and potential side effects).
Phase II - where a treatment is administered to a larger group of people (several hundred) to determine efficacy (whether the treatment works) and to further evaluate its safety.
Phase III - where the efficacy of a treatment is assessed using large groups of participants (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions. Futher issues related to safety are also studies at this time.
Phase IV - these studies are conducted after a treatment has gone out to market. These studies are used to assess the effectiveness of the treatment in the general population and to further understand any safety issues in the general population over a longer period of time. These studies might also explore the potential use of the intervention in a different condition, or in combination with other therapies.
Insight provides a range of services for designing, conducting and analyzing studies of pharmaceuticals and other treatments. These services include helping obtain regulatory approval and regulatory reporting. They also include assisting with treatment allocation. It is generally recommended that such studies involve double blinding where both patients and staff are unaware of which treatment group specific patients are allocated to. As such Insight can assist both with designing the allocation scheme, and can also physically manage the treatments so that the study team is blinded to the treatment allocation.
Insight is based at the Gold Coast Health and Knowledge Precinct. The Precinct contains Griffith University Gold Coast, the Gold Coast University Hospital, the Gold Coast Private Hospital, and the Cohort and Lumina tech parks. Insight provides research, consulting, training, and IT support services for clients across the Precinct and for the broader international community.