Glasgow CR-UK CTU IHTAB application form
V0.1 30 Dec 2013
CR-UK CTU Glasgow In House Trials Advisory Board (IHTAB)
Application for CTU study support
The IHTAB meets every two months to review new requests for support.
This document should be submitted in advance of the meeting and will form
the basis for discussion at the IHTAB.
During the meeting you will be asked to attend to present the proposed study
and to answer any questions from The Board members. After you have left
the meeting, The Board will then advise the CTU whether or not to offer
support to your study.
Please note, that The Board’s assessment will be based on a variety of
factors including:
1. The quality of the study
2. Whether or not the study fits with the scientific strategy of the CTU
3. Available resources in the CTU.
It is possible that there will be some studies which are considered worthy of
support, but not suitable for the Glasgow CR-UK CTU. In this case, the IHTAB
will attempt to direct you to a more suitable CTU.
CTU staff welcome the opportunity to discus outlines with potential
investigators in advance of an IHTAB submission, and it is possible that
IHTAB will advise resubmission with revision.
For further information about the scientific strategy of the CR-UK CTU, please
see the appendix to this document.
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Glasgow CR-UK CTU IHTAB application form
V0.1 30 Dec 2013
Title of proposed study
Primary objective
What is the main question to be answered?
Pathway
a. How will this study ultimately bring about change clinical practice?
Please outline subsequent studies that will need to be done should the proposed study
prove ‘positive’ in order to bring about the change.
b. What are the expected benefits at the end of the pathway?
Eg. Improved survival, reduced toxicity, cost savings
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Glasgow CR-UK CTU IHTAB application form
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Rationale
a. Describe unmet need. Include a short summary of results/conclusions from prior
studies, or from a systematic review, as appropriate.
b. Please identify if any of the previous work has been done by, or in collaboration with,
Glasgow-based investigators1
1
Note: this is not a requirement for CR-UK CTU support
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Glasgow CR-UK CTU IHTAB application form
V0.1 30 Dec 2013
Design
a. What type of study is it?
Eg. Randomized phase II trial, observational study, methodology study
b. Population
List the key eligibility criteria
c.
Interventions
What, if any, are the proposed interventions in each arm of the study?
d. Comparator
What population will the intervention group be compared to?
e. Outcome
Please list the primary, secondary and exploratory outcome measures
f.
Size
Estimate how many patients will be required (this will be reviewed by a statistician
later).
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Novelty
Are there on-going / previous studies which have asked the same question? If so, how does
the proposed study complement these others?
Translational research2
a. Will samples be collected for translational research?
b. Are there pre-specified translational endpoints?
If so, what are they?
Are the assays ‘study ready’, or will this study be used to help establish the
methodology?
c.
Which (if any) Glasgow laboratories are involved in the proposed translational work
(including the Analytical Services Unit)? 3
2 Where
possible, CR-UK CTU strives to maximize impact through translational research,
although we will consider studies with purely clinical outcome measures
3 CR-UK CTU do not work exclusively with Glasgow laboratories
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Glasgow CR-UK CTU IHTAB application form
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Feasibility
a. Are there other trials (current or planned) which will compete for these patients in the
UK national portfolio during the likely period of recruitment to this trial?
b. What engagement has there been with appropriate UK and / or international groups
regarding this study? (Identify any issues raised)
c.
How many patients per month are there in your local practice which meet the
proposed entry criteria? Please describe the basis for this estimate.
d. How many patients per month are likely to recruit to the study across all proposed
sites? Please describe the basis for this estimate
e. Which aspects of the proposed study may prevent an eligible patient consenting to
participation?
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Funding
a. Is the study likely to require external funding?
Yes / No
b. What are the likely grant-funding streams available?
Please include closing dates if known.
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Glasgow CR-UK CTU IHTAB application form
V0.1 30 Dec 2013
Appendix: Strategic development of the Glasgow Cancer Research UK
Clinical Trials Unit (CR-UK CTU) portfolio
Version 0.3
“Scientific innovation driving better patient outcomes”
The portfolio of the Glasgow CR-UK CTU is developing to reflect the priorities
listed below. The In House Trials Advisory Board (IHTAB) is ultimately
responsible for shaping this portfolio and, whilst it welcomes any high quality
proposal, priority will be given to those which enable the portfolio to build this
shape. IHTAB will consider these criteria critically during the proposal
assessment process, and potential Chief Investigators are encouraged to
consider these priorities when making proposals to IHTAB.
1. The CTU trials portfolio will focus on translational medicine
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Reflecting local pre-clinical / translational laboratory expertise
Encouraging national and international collaboration
Maximising value of translational sample collections within trials present, past and
future
Working with the Glasgow ECMC to enable delivery of this objective
2. The CTU will continue to develop expertise in the following disease areas.
This range of diseases reflects the priorities of the Glasgow Cancer Centre,
the priorities of CR-UK and the expertise of local investigators. IHTAB will
continue to welcome proposals in other disease areas which reflect other
priorities of the portfolio.
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Gastrointestinal cancer (colorectal cancer, pancreatic ductal adenocarcinoma
(PDAC), gastroesophageal cancer)
Gynaecological cancer,
Urological cancers (prostate, bladder and kidney)
Lung cancer
Chronic Myeloid Leukemia
Rare cancers (including Central Nervous System (CNS) and International Rare
Cancers Initiative (IRCI))
3. An essential criterion is that the proposed trial is part of a clear pathway
that could ultimately change practice and improve outcomes for patients.
Reflecting this, the CTU will develop a portfolio focused on:
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Trials which, if positive, will in themselves change practice
Trials where the ultimate objective is to introduce a biomarker into practice-changing
treatment
Early drug development
Trials including radiation
Non-interventional clinical studies which support the development of the above
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