Expressions of Interest for the Investigator - Initiated Trial Capacity Building (“IIT”) Program

⁠⁠⁠The Investigator-initiated Trial Capacity Building (“IIT”) Project is part of the Strategic Research Plan (“SRP”) (https://www.viccompcancerctr.org.au/about-the-vccc/strategic-research-plan/) of the Victorian Comprehensive Cancer Centre (“VCCC”) and is it’s largest single investment with a budget of just over $8m with the aim to increase cancer patient accrual on clinical trials. The VCCC is investing a total of $20m in various clinical trial programs. The IIT program will provide resources to help more investigators to open and conduct a clinical trial and will significantly increase the number of investigator-initiated trials performed at VCCC sites.

Increased support for investigator-initiated trials is the highest strategic priority for the VCCC, aligning with recognition at a national level that this is the number one unmet need in the clinical trials sector. It is recognised that infrastructure to support non-commercial, ‘public good’ trials is not being addressed within current efforts to improve the conduct of clinical trials in Australia. These trials benefit patients by asking questions that pharmaceutical or biotech industries are unlikely to invest in. On average, non-commercial trials at VCCC sites recruit more patients per trial than commercially-sponsored trials.

The program is broken into two components:
1. Creation of a VCCC Clinical Trial Development Hub to support idea generation, protocol development, mentoring of investigators.
2. Development of a VCCC Clinical Trial Assistance Scheme to provide access to resources to support the development, conduct and management of selected investigator-initiated and non-commercial trials.

These components form the basis of this call for Expressions of Interest. The assistance scheme will provide support from three different services:
1. Biostatistical support for trial design, interim analysis and for final analysis.
2. Clinical Trial Management: Support for developing budgets, meeting regulatory requirements and for overall trial management at a central level, including data integrity (i.e. services provided by CROs and coordinating centres).
3. Clinical Trial Site Management: Local site management of budgets, ethics submissions, governance requirements, 3rd party contracts (eg with radiology, pathology, pharmacy) and, in some environments, management of staff engaged in the trial conduct at the site itself.

This call for Expressions of Interest is intended to identify potential partners of the VCCC for the provision of the 3 services, noting that invitees may apply to provide just one or more than one of them. The expression of interest for biostatistical support is through an invitational process with the other two services being an open call.

There is considerable overlap between these three elements at different stages of developing and successfully running a clinical trial so it will be essential that those providing the services can work well together and be responsive at each stage they are required. Invitees are expected to provide examples of how they have worked across the spectrum of services even if they are only applying for one of them.

Whilst VCCC recognises that giving a single quotation is not possible for these services as it will depend on the nature of the service required and that this is dictated by the size and complexity of any clinical trial, invitees should be able to provide indicative unit costs for any of the elements outlined in this request for EOIs. As a guide, invitees should consider use of the following examples as a means to illustrate their approach, capabilities and costings. Invitees are free to add additional examples if they choose to do so.
1) A phase I first in human interventional IIT based at a single site that will recruit 20-30 patients.
2) A phase II interventional IIT based at 3 sites that will recruit 100-200 patients
3) A Phase III interventional IIT based at 7 or more sites that will recruit >200patients
4) A comparative effectiveness trial comparing two standard-of-care (already registered products) of 200 patients across 5 sites
5) A survivorship study (eg psychological intervention or observational study) of 500 patients across more than 5 sites.

Please note that costs associated with HREC and governance fees, investigator and staff salaries, investigational products, site fees and third party fees are not considered in scope for this EOI. Invitees should limit details of their indicative costings to the provision of the services outlined above.

The EOIs received will be reviewed by a panel of experts from the VCCC and its members as well as any external experts as required. Strict confidentiality regarding any submissions by invitees will be adhered to and is noted in the terms and conditions. Invitees may be called upon to provide additional details and to meet with the VCCC project management team to clarify any aspect of their submission. The Successful invitee(s) will be asked to undertake a process to enter into a contract with the VCCC. Unsuccessful applicants will be notified of the decision and be provided with feedback regarding the decision. The VCCC procurement processes will be adhered to at all times. These processes aim to align with the VGPB policies in regard to procurement.

Suppliers should be able to meet service provision from April 2018.