Clinical Trials Metrics
In July 2016 the NSW Office for Health & Medical Research (OHMR) introduced a requirement for all NSW Local Health Districts (LHDs) to provide data for clinical trial metrics. These metrics will be utilised to measure the success of reform initiatives introduced by OHMR to improve trial approval and enrolment processes, and to improve NSW’s ability to competitively initiate and deliver health and medical research, including clinical trials.
The data collection process is facilitated and managed through the Concord Hospital Research Office. For commercially-sponsored trials only, investigators will be asked to provide data for two metrics:
Metric 5 - Date first participant is enrolled to the clinical trial. If this date is more than 40 days after site authorisation, a reason for lack of enrolment will need to be provided. This data will be collected for all commercially sponsored clinical trials where an SSA authorisation has been issued on or after 01/07/2016.
Metric 6 - Total number of participants enrolled over the life of a clinical trial at Study Closure (ie when study is closed to enrolment/recruitment at the site). If the total number of participants enrolled to the trial is less than the minimum enrolment target for the site (as specified in the CTRA), a reason for not reaching target will need to be provided. This data will be collected for all commercially sponsored clinical trials closed to enrolment at the site on or after 01/07/2016.
More information about the NSW Metrics for Health and Medical Research, including Clinical Trials can be found here.