The Strategic Platform for Clinical Trials Support and Enablement aims to encourage and support high quality clinical trial activity within the partnership, streamline approval and governance processes, and improve patient access to, and recruitment into clinical trials. It seeks to support and nurture sector growth, financial return and sustainability for Maridulu Budyari Gumal partners and other key stakeholders.
Wide-ranging consultative processes have been used to develop a capability and capacity framework which will underpin the partnership's priorities in the coming years.
The work of the Platform is supported by the Clinical Trials Methodology Hub and the Research Ethics & Governance Steering Committees which include members from across Maridulu Budyari Gumal, but also from neighbouring health translation centres.
Maridulu Budyari Gumal Clinical Trials Microsite
View our dedicated website for Clinical Trials. On www.sphereclinicaltrials.com.au we connect you to information that underpins the development and delivery of successful Clinical Trials.
A virtual facility to enhance and enable investigator-led clinical trial knowledge and activity, and to facilitate access to expertise in clinical trial design, methodology, biostatistics, health economics, consumer and community involvement and trial conduct.
We are building professional networks of industry experts such as Biostatisticians, Human Research Ethics Committees (HREC) Chairs and Clinical Trials Unit Managers to:
- reduce professional isolation and encourage broad collaboration and innovation
- enable the sharing of knowledge and expertise to build broad capacity
- find solutions to overcome common problems
- support and encourage career progression and employment stability through mentorship and ongoing education and training opportunities
- collaborate with equivalent district, state and national professional networks
- provide advice at the District, State and Federal Government levels.
We are facilitating Incubator Sessions to support early- and mid-career investigators to develop clinical trial protocols. These sessions involve a multi-disciplinary panel of clinical trial experts and consumer representatives providing feedback and advice on ideas for clinical trials. This panel can also assist in the establishment of a multi-disciplinary investigator team and increase the quality of clinical trial protocols, funding and ethics applications. Investigators are also made aware of the procedures and processes required prior to trial commencement.
A curated selection of state, national and international Clinical Trials Start-Up resources including an overview of requirements and weblinks to the ethics and governance resources of the partner institutions.
We are working with training partners to deliver high quality, industry recognised training for clinical trial site personnel and members of ethics committees.
Our Good Clinical Practice training program, developed and hosted by Sophie Mepham GCP™ (SMGCP) is up and running. This includes trained facilitators to deliver workshops and online, self-directed courses.
Staff from across the partnership can access:
- Introduction to GCP
- Refresher GCP
- GCP for associated staff – short session GCP
Free online GCP training for Maridulu Budyari Gumal partner organisations. Available now.
You can read more about these courses, what they cover and how to access them on the SPHERE Clinical Trials website: https://www.sphereclinicaltrials.com.au/gcp-training-suite
For more information on our GCP training contact firstname.lastname@example.org
To celebrate International Clinical Trials Day, we are proud to release the Being Audit Ready Resource Pack. The pack includes:
- Applying GCP to audits of Clinical Trials
- Guideline for developing a Standard Operating Procedure for an external audit of an NSW clinical trial site
- Clinical Trial Audit Checklist for Sites
- Podcast – Clinical Trials in Focus “Being Audit Ready”.
These resources were developed in collaboration with Sydney Health Partners and NSW Regional Health Partners for use and adaption by our partner organisations.
The Clinical Trials Strategic Platform Team
Merrilee Kessler, Project Officer Clinical Trials