Definition of a clinical trial
The World Health Organisation (WHO) definition for a clinical trial is, 'any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes'.
Definition of an intervention
The WHO defines interventions to include, but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc.
What is coaching or mentoring
This is where the Clinical Trial Development Panel or the investigator submitting the project identify an area where an expert in a specified area could assist you with direction or clarification. The VCCC will assist with identifying and coordinating a series of meetings to allow goals to be achieved. For example, assistance with an experienced investigator, a regulatory expert or an expert in writing budgets.
What is trial management
Trial management support services are provided to successful applicants via the Trial Assistance Scheme. An example of these services includes protocol development, case report form development, database design and management, risk management and safety reporting.
What is site management
Site management support services are provided to successful applicants via the Trial Assistance Scheme. An example of these services includes all clinical trial agreements, budgets and milestone payments, ethics submission preparations of the initial protocol and consent forms and all subsequent amendments as necessary.
What is included in biostatistics
Full biostatistical support via the Trial Assistance Scheme can include statistical input into the protocol development, ongoing statistical support during the trial, data analysis and reporting of results. You can also utilise limited statistical support through the knowledge hub via the coaching program.
What amount of funding does this EOI offer
No money will be given directly to the successful applicants, the VCCC provides the support services for the project and has a contract directly with the support service provider, external to the investigators.
What funding does the investigator need to secure
The investigator needs to ensure all funding is secured or able to be secured for the project to enable them to conduct the study at a site level. This includes such things as drug supply, trial specific investigation reimbursements, staff costs. The VCCC will not fund the project at a site level, nor provide funds to cover trial activities outside the Trial Assistance Scheme.
Who will sponsor the project
The investigator needs to ensure they have institutional support to sponsor the multisite study, all normal processes will be followed at the individuals sponsoring sites as per standard requirements. The VCCC cannot act as sponsor.
Definition of an early career researcher
An early career researcher is within 10 years of the year they obtained their specialist qualification or research higher degree, whichever occurred later. Number of years are adjusted for career disruption as defined by NHMRC.
What key areas are considered in the evaluation
The evaluation criteria will focus on potential impact of the project, feasibility, recruitment impact and indirect benefits for the VCCC alliance partners and greater Victoria.
Do I need to list all individuals involved in the project
Yes please, list all individuals and organisations involved in the project. This is critical in allowing the reviewing panel to adequately assess conflict of interest and early career researchers involved.