NSW GOVERNMENT-SPONSORED CLINICAL
TRIALS FOR CANNABIS/CANNABIS PRODUCTS
The NSW Government has committed to furthering research into the potential of
cannabis and cannabis-derived products to ease the suffering of people with debilitating
or terminal illnesses. The project should help establish NSW as a leader in the field of
cannabis-based research and improve the evidence base for the use of these products.
EXPRESSIONS OF INTEREST
APPLICATIONS CLOSE 27 FEBRUARY 2015
NSW Cannabis Clinical Trials 2015
1. Introduction
The NSW Government has made a commitment to research that will enhance the evidence
base around the therapeutic use of cannabis and cannabis-derived products. The NSW
Therapeutic Cannabis/Cannabinoid Trials will be administered through the NSW Ministry of
Health.
It is noted that many clinical trials involving the medical use of cannabis products have been
limited by poor research design including poor definition of patient selection criteria;
inappropriate comparators; inadequate blinding of interventions or definition of intervention
(eg components of different cannabis products) or small sample sizes such that a
therapeutic difference is unlikely to be detected at a level of significance; lack of optimisation
with conventional therapy for trial participants; differences in mode of delivery of products
and inadequate treatment in either the cannabis/cannabis-product treated or control groups.
It is important that any trial funded under this scheme addresses these concerns.
An Expert Panel has advised that the most promising areas of research where NSW can
most likely advance the evidence are in the areas of drug-resistant chemotherapy
induced nausea and vomiting (CINV) and symptom relief in terminal illness.
Any clinical trial will need to adhere to the National Statement on Ethical Conduct in Human
Research (2007) (National Statement (2007) and The Australian Clinical Trial Handbook.
The NSW Government has committed to supporting research in these areas and is willing to
assist groups wishing to use cannabis products in their research to navigate the regulatory
channels to bring this research to fruition.
It is expected that researchers will show engagement with consumers in developing their
research proposal and in conducting the research.
There will be a two stage process for all applications: a preliminary expression of interest
(EOI); followed by an invitation for full submissions for those applicants who are selected by
an independent panel.
Funding will be made available for up to three years.
2. Details of grant funding




Applications are invited from NSW-based researchers who are currently in or will form
team/s demonstrating an ability to perform research in the given area. Where a product
needs to be developed or acquired this should be clearly stated. For inter-state or
international applicants there needs to be a substantial research benefit to NSW for the
application to proceed (i.e. Chief Investigator must be located in NSW, the Administering
Institution must be in NSW, at least 50% of the research team must be based in NSW
and a substantial majority of trial participants must be NSW residents).
Each project may be eligible for funding of up to $2 million over 2-3 years, commencing
in June 2015.
Funding will support the establishment of a clinical trial into the areas of drug-resistant
chemotherapy induced nausea and vomiting or use of cannabis products for
symptomatic relief in terminal illnesses.
Funding will be competitive and merit based.
Expression of Interest
2
NSW Cannabis Clinical Trials 2015
Use of funds
Funding provided by the NSW Government for these clinical trials may be spent on a cost
incurred in relation to the clinical trial project that satisfies all of the following requirements:
 The cost must be integral to achieving the objectives and outcomes of the Research
Activity as set out in the Application for Funding for that clinical trial project, as approved
by the NSW Government
 The cost must be directly related to the proposal as set out in the Application for Funding
for that Research Activity, as approved by the NSW Government, and
 The cost must not be for a facility or an administrative cost that would be provided by an
institution in the normal course of undertaking and supporting health and medical
research.
Progress reports and financial reports will be required over the life of the grant.
3. Assessment criteria for the EOI and full application (Based on NHMRC funding
criteria)
Selection will be determined by an independent panel and judged against adherence to the
assessment criteria below. Criteria are based on the NHMRC program grants for ease of
cross-application for grants.
1. Scientific Quality (50%)
- Strong scientific basis for the work proposed
- Well defined objectives, highly coherent and strongly developed
- Highly feasible methods that have a high probability of achieving the objectives.
2. Significance of the expected outcomes and/or innovation of the concept (25%), and
- Will result in a significant or major advance in knowledge in this field or address an
issue of significant importance to human health in NSW
- Is likely to translate into fundamental outcomes in the science and/or practice of
clinical medicine or public health
- Will provide a value for money result for NSW Health.
3. Team quality and capability, relative to opportunity (25%)
- Expertise and experience that is highly relevant to the proposed research.
- Ability to demonstrate experience in translational research
- Demonstration of successful collaboration or the potential for successful
collaboration.
Applicants will also need to show that they have considered how to engage with consumers
in developing their application.
4. Application process
Applications will only be accepted from researchers who are affiliated with research
institutions based in NSW.
The application process will be held in two stages:
1. The submission of an EOI
2. Invitation to submit a full application following assessment of the EOI by an
independent selection panel will occur within one month from the close of EOIs, and
3. Submission of a full application upon invitation by May 16, 2015.
Expression of Interest
3
NSW Cannabis Clinical Trials 2015
The EOI and the CVs of the research team must be submitted to the NSW Ministry of Health
prior to the deadline of 5pm, 27 February 2015. Please see details below regarding the
submission of applications.
All submissions must use the application form provided in Appendix A below.
Late or incomplete application forms will not be considered.
Submission of expressions of interest
Applicants should submit one (1) electronic copy and six (6) hard copies of the expression of
interest form and associated documentation as listed within the EOI form. Applications
should be single-sided and A4 unbound. Electronic copies should be submitted as PDF
format or .doc and be named: [CHIEF INVESTIGATOR NAME]_Cannabis2015EOI_[DATE
you emailed the document]
The Ministry requires all hard copies to be formally lodged. (i.e. in person, signed courier or
registered post).
Hard copies should be sent:
by mail to:
OR
Dr Jan Fizzell
Medical Advisor
Office of the Chief Health Officer
NSW Ministry of Health
LMB 961
North Sydney NSW 2059
in person or by courier to:
Dr Jan Fizzell
Medical Advisor
Office of the Chief Health Officer
NSW Ministry of Health
73 Miller St
North Sydney NSW 2060
The electronic copy should be emailed to ocho@doh.health.nsw.gov.au
Enquiries may be directed to:
Dr Jan Fizzell
Medical Advisor
Office of the Chief Health Officer
Tel. (02) 9391 9235
Email: jfizz@doh.health.nsw.gov.au
Both electronic and hard copy EOIs must be received by 5pm 27 Feburary 2015.
Expression of Interest
4
EXPRESSION OF INTEREST FORM
NSW GOVERNMENT-SPONSORED CLINICAL TRIALS FOR CANNABIS/CANNABIS
PRODUCTS 2015
DEADLINE 5PM 27 February 2015
SECTION A – ADMINISTRATIVE SUMMARY
A.1
Application title
Provide a short descriptive title (maximum 200 characters including spaces):
A.2
Administering institution in NSW
Administering institution details:
Institute name
A.3
Administering institution contact
Select a title: Choose a Title
Family name:
Given name:
Postal address:
Telephone:
Mobile:
Email:
A.4
Chief Investigator details
Select a title: Choose a Title
Family name:
Given name:
NSW Cannabis Clinical Trials 2015
Postal address:
Telephone:
Mobile:
Email:
Are you an Australian Citizen/ Permanent Resident?
Are you located in New South Wales?
YES
YES
☐
☐
NO
NO
☐
☐
SECTION B – PROJECT PROPOSAL
B.1
Lay project summary
In lay terms summarise the application referring to aims, significance and expected
outcomes suitable for NSW Health website and media releases (maximum 2500
characters including spaces):
B.2
Short form proposal
Summarise the application referring to aims, significance and expected outcomes. Please
include how the project meets the aims and use the guidelines under each heading
(maximum 500 words):
1. Objectives, design and expected outputs and outcomes (50%)
This should include an outline of the study design under the following headings: Aims
and Objectives, Background, Research Plan (include brief Sample Size Calculation),
Analysis, Specific Outputs, Expected Outcomes. Responses should correspond with the
Selection Criteria. It should include a description of the population in which the trial will
take place, the type of cannabis to be trialled (or possible types of cannabis-derived
products), the comparator and expected outcomes.
2. Significance of the expected outcomes and/or innovation of the concept (25%)
Outline the clinical relevance of the project and the likely impact it will have on clinical
practice in NSW, Australia and the world. Proposals should focus on areas of substantial
research need and benefit, where the outcomes are anticipated to be feasible for
adoption into the health system if the trial produces a positive result, particularly where
this may lead to additional uses of an established product on the ARTG or where this
may contribute to a listing on the ARTG. Provide a brief analysis as to how the impacts
of the project as described will deliver ‘value for money’ in the health system.
Expression of Interest
6
NSW Cannabis Clinical Trials 2015
3. Team quality and capability, relative to opportunity (25%)
The expertise and experience of the research team relevant to the project, their collaborative
potential and potential collaborators and success in obtaining and delivering past grant
funding. An overview of previous achievements of the team and/or of collaborative effort of
team members should be provided:
SECTION C – CANNABIS/CANNABIS PRODUCTS FOR TRIAL
C.1
Type of product and assistance required for trial to take place (provide as much detail
as possible):
ITEM
DETAILS
Include source (if known),
registration status in Australia,
expected time to acquisition,
expected THC content, expected
content of other cannabinoids,
understanding of other important
cannabis compounds that may be
in product
ASSISTANCE REQUIRED TO
BRING TRIAL TO
COMMENCEMENT
(e.g. import licenses, licenses to
manufacture, CTN/CTX
notification, assistance in finding
partners to supply product)
Cannabis
product
proposed
Placebo
product
proposed
(if any)
Expression of Interest
7
NSW Cannabis Clinical Trials 2015
SECTION D – ETHICS
D.1
Ethics
Please outline whether ethics approval has been obtained;
If yes – Please include which ethics committees have approved the project. If there are any
conditions attached to the approval, please outline these as well.
If no – Please outline your plan for ethics approval.
SECTION E – CONSUMER ENGAGEMENT
E1.
Outline how relevant informed consumers have been involved during the
development of the research proposal and the plan for ongoing consumer
involvement in the research. Explain how this/these consumer(s) are ‘qualified’ to be
involved:
Expression of Interest
8