What we do - Clinical Trial Management
Key activities | Trial management | Quality assurance |
Every cancer trial starts with a question or an idea. Oncology professionals come to us with an idea and TROG Cancer Research facilitates the process of developing that idea into a rigorous clinical cancer trial.
First, we assist the researcher to develop their idea into a formal proposal which is then submitted for endorsement by our Scientific Committee and ultimately our membership. In other words, the proposal is peer reviewed by up to 300 clinical professionals for validity and feasibility.
We then facilitate the development of the protocol, statistics and budgets. We arrange ongoing peer review with a dedicated Trial Management Committee and develop the Quality Assurance requirements that will be applied continuously throughout the life of the trial. TROG Cancer Research will ensure all indemnity, contractual and regulatory documentation is complete. We prepare all record keeping documents and set up a records database. All of these elements comply with strict international Good Clinical Practice standards.
Once these processes are complete, TROG’s Scientific Committee approves a trial for ‘activation’ and only then does patient recruitment begin.
TROG’s Central Operations Office is equipped to provide full trial coordination centre activities from the time of trial concept through to completion and publication in medical journals.
TROG Cancer Research works with radiation therapy treatment centres and researchers to ensure:
- patient recruitment and data collection targets are being met
- patient safety is monitored
- data is being collated and primary/final endpoints are reported
- reporting timelines to regulatory agencies are met
In order for the results of a trial to be published and adopted into clinical practice, data must be accurate. Quality Assurance (QA) provides the framework for verifying data accuracy and protocol compliance. It also ensures that safety issues for patients on a trial are identified as soon as possible and rectified.
The world of radiotherapy is rapidly evolving with new technologies and treatments being developed both nationally and internationally. To incorporate these innovations into clinical trials, QA procedures must be developed. TROG reviews international standards for credentialing these new techniques, and incorporates the use of technologically advanced dosimetric phantoms and software. In doing this, we ensure our researchers have access to the best available resources for conducting their research.