Page 1450 - Week 04 - Thursday, 4 April 2019
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Definitions:
Phase I – testing a new biomedical intervention for the first time in a small group of humans (e.g. 20-80) to evaluate safety (e.g. to determine a safe dosage range and identify side effects).
Phase II – studying an intervention in a larger group of people (several hundred) to determine efficacy and to further evaluate its safety.
Phase III – studying the efficacy of an intervention in large groups of trial participants (from several hundred to several thousand) by comparing the intervention (new drug) to other standard or experimental interventions (or to non-interventional standard care). Phase III studies are also used to monitor adverse effects and to collect information that will allow the intervention (drug) to be used safely in human beings.
Phase IV – conducted after an intervention (drug) has been approved marketed. These studies are designed to monitor the effectiveness of the approved intervention (drug) in the general population and to collect information about any adverse effects associated with widespread use over longer periods of time. Phase IV may also be used to investigate the potential use of the intervention in a different condition, or in combination with other therapies.
(2) Determining this will require a significant commitment of resources to respond to this question accurately.
(3) Health and medical research are a core business for the ACT Health Directorate and Canberra Health Services. Canberra Health Services includes teaching hospitals of the Australian National University, the University of Canberra and the Australian Catholic University.
Other than Ethic reports, at present it is not possible to provide project level outcome details for the 1133 health and medical research projects and clinical trials conducted in the period 2012-2018. Collection of this information requires sophisticated software that is currently not available to the ACT Health Directorate or the Canberra Health Service.
As previously noted, the Centre for Health and Medical Research is using grant funding to custom build a sophisticated clinical trials management system.
(A copy of the attachment is available at the Chamber Support Office).
Homelessness—overnight shelters
(Question No 2148)
Ms Le Couteur asked the Minister for Housing and Suburban Development, upon notice, on 15 February 2019:
(1) What are the conditions in service funding agreements about opening hours for One Link and for the Early Morning Centre, with particular regard to Christmas shutdown.
(2) How many bed nights were provided by the Christmas Domestic Violence initiative this year and have all people supported through that initiative been able to find an exit point from the refuges or hotel accommodation.
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