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Consultation Paper
Clinical Trials Ready
PLEASE PROVIDE YOUR RESPONSES TO THE CONSULTATION QUESTIONS VIA THE
NHMRC ONLINE CONSULTATION PORTAL AT http://consultations.nhmrc.gov.au/
April 2015
UNCLASSIFIED
Background
The Australian Government is committed to improving the clinical trials environment and increasing Australia’s
international competitiveness as a destination of choice for the conduct of clinical trials. In order to effect this
commitment NHMRC, along with the Department of Industry and Science and the Department of Health, are
undertaking a number of activities to streamline research ethics and governance approval, improve training and
education of clinical trial proponents and increase recruitment into clinical trials.
One initiative being considered is the recognition of clinical trial sites, including public and private hospitals and
other organisations that are ‘ready, willing and able’ to carry out high quality clinical trials in a timely, transparent
and efficient manner. This proposed initiative is known as ‘Clinical Trials Ready’. NHMRC is now conducting a
consultation on this initiative.
A similar initiative is already in place in the United Kingdom. The UK Clinical Research Collaboration (UKCRC,
http://www.ukcrc.org/) has a Registered Clinical Trial Unit (CTU) scheme that registers CTUs that meet a list of
criteria. More details are available at http://www.ukcrc-ctu.org.uk/.
The main potential benefits of the Clinical Trials Ready initiative would be:
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Improved awareness, transparency and clarity,
Less duplication of ethics and governance review processes; and
More clinical trials would be attracted to Australia, due to faster approval processes, transparency in
costs and timeframes, and the high quality of the research.
Purpose of the Consultation
The intended outcome of the consultation is an understanding of the views of stakeholders, including clinical trial
sites and sponsors, on a number of fundamental aspects of the Clinical Trials Ready initiative. These aspects
include:
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Whether it would add value to the existing system for conducting clinical trials in Australia;
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If such a scheme is desirable, what the characteristics that distinguish Clinical Trials Ready sites might be; and
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Views on the governance and management of the Clinical Trials Ready initiative.
Terminology and definitions used in this document
Clinical Trials Ready – A proposed initiative to recognise Australian clinical trial sites that meet certain published
criteria.
Site – an institution (or group of institutions) that resource, conduct and manage clinical trials that come under one
final research governance authorisation sign off.
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Consultation Questions
1) Please indicate which of the following you represent (selecting multiple options if appropriate):
Clinical Trial site- public hospital
Clinical Trial site- private hospital
Phase one clinical trial facility
Clinical Trial Network
Consumer/patient
Collaborative Research Group
Clinical trial researcher
Peak Body
Government
Human Research Ethics Committee member
Physician or allied health professional with an
interest in clinical trials
Clinical Trial sponsor- pharmaceutical
Clinical Trial sponsor- medical device
Clinical Trial sponsor- other
Contract research organisation
Site management organisation
Clinical trials coordinator/manager
Other (please insert details)
2) Do you consider being recognised as ‘ready, willing and able’ to carry out high quality clinical trials
would make clinical trial sites more attractive to potential sponsors?
3) What are the key characteristics of a clinical trial site that would indicate to potential sponsors that
the site is ‘ready, willing and able’ to carry out high quality, timely, transparent and efficient clinical
trials?
4) Please comment as to how such a scheme might be achieved and managed.
5) Which clinical trial sites should be eligible for recognition? For example, should there be any
restrictions on eligibility based on the trial phase expertise of sites, or the type of institution (i.e.
hospital vs. independent medical research institute vs. university vs. general practice/community)?
6) Please consider the possible Clinical Trials Ready criteria below and rate the importance of the
criteria, as well as providing any other comment you might have.
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Possible Clinical Trials Ready criteria
It is proposed that clinical trial sites will have to meet a set of criteria in order to be recognised as Clinical Trials
Ready. The following section details possible criteria that could be used to characterise Clinical Trials Ready sites
and the reason for suggesting the criterion.
Please rate the importance of these suggested criteria in identifying sites that are ‘ready, willing and able’ to carry
out high quality clinical trials, including any comments you might have. Please also suggest any additional criteria
and rate their importance.
1)
Strategic intent: Clinical research is a key strategic objective.
A commitment to clinical research as an essential strategic objective of the site will indicate to sponsors and
other stakeholders that the site is committed to clinical research, and allocates resources towards clinical
research excellence.
Please rate importance: ☐ Critical ☐ Important ☐ Minor importance ☐ Not important
Other comments:…………………………………….
2)
Standards: Applicable standards are promoted and applied to all activities
These standards might include:
 The Australian Code for the Responsible Conduct of Research (2007) or its successor;
 The National Statement on Ethical Conduct in Human Research (2007) - Updated March 2014 or its
successor;
 NHMRC / Consumer Health Forum Statement on Consumer and Community Participation in Health and
Medical Research (2002) or its successor;
 Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research
(2003) or its successor;
 Applicable Good Clinical Practice guidelines;
 NHMRC Australian Health Ethics Committee Position Statement on monitoring and reporting of safety for
clinical trials involving therapeutic products; and
 Applicable State or Territory standards.
Please rate importance: ☐ Critical ☐ Important ☐ Minor importance ☐ Not important
Other comments:…………………………………….
3)
Resources: Sufficient resources are in place to ensure an effective and efficient site assessment
process.
Delays in the clinical trial application and assessment process are a significant concern to clinical trial
sponsors and can significantly add to site administrative staff costs. By having sufficient resources and
appropriate critical mass in place, the site is demonstrating their commitment to improving the application and
assessment process. This may include ongoing training for all persons involved in clinical trials administration,
review and conduct ensures a globally competitive workforce.
Please rate importance: ☐ Critical ☐ Important ☐ Minor importance ☐ Not important
Other comments:…………………………………….
4)
Quality improvements: An ongoing commitment to improvement in all clinical trial processes, with
a focus on quality, efficiency and transparency.
Including, but not limited to, the clinical trial:
 application;
 assessment;
 participant recruitment, care and oversight;
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 execution and compliance with trial requirements;
 management; and
 communication processes.
Please rate importance: ☐ Critical ☐ Important ☐ Minor importance ☐ Not important
Other comments:…………………………………….
5)
Governance processes: Applies the national good practice governance approval process for
clinical trials (when published).
NHMRC has developed the national good practice governance approval process in broad consultation with
stakeholders. Further information is available at http://www.nhmrc.gov.au/research/clinical-trials/nhmrcclinical-trials-initiatives.
Please rate importance: ☐ Critical ☐ Important ☐ Minor importance ☐ Not important
Other comments:…………………………………….
6) Single ethical review: Provides access to, and accepts a single ethical review from a Human
Research Ethics Committee (HREC) certified under a single ethical review scheme.
Information on the NHMRC National Certification Scheme and the Interjurisdictional National Mutual
Acceptance scheme is available at https://hrep.nhmrc.gov.au/certification/hrecs.
Please rate importance: ☐ Critical ☐ Important ☐ Minor importance ☐ Not important
Other comments:…………………………………….
7) Participant recruitment: Processes are in place to assess the feasibility of trial conduct and
maximise the recruitment of clinical trial participants.
The recruitment of sufficient participants is a critical requirement for clinical trials. An effective active
recruitment management process should:
 Ensure the site knows the local population and disease demographics,
 Ensure the site has appropriate access to data sources, such as patient databases, to accurately assess
trial feasibility;
 Ensure that a trial is only accepted if an assessment has been made that it is feasible, including whether
recruitment targets can be met,
 Develop and implement a participant recruitment plan at the beginning of a trial;
 Set and actively monitor recruitment milestones and implement strategies to ensure they are met; and
 Consider the potential for clinical trial recruitment at all points in a patient’s journey through the healthcare
system.
Please rate importance: ☐ Critical ☐ Important ☐ Minor importance ☐ Not important
Other comments:…………………………………….
8)
Costs: Transparent costs for clinical trial activities and trials are carried out in an efficient and costeffective manner.
It is recognised that costing of clinical trials is a complex issue and that aspects such as standard of care can
vary between physicians, departments and institutions the Independent Hospital Pricing Authority framework
may decrease the time taken for budget negotiations, and increase transparency.
Please rate importance: ☐ Critical ☐ Important ☐ Minor importance ☐ Not important
Other comments:…………………………………….
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9)
Available information: Publicises areas of clinical trial focus and expertise
Advertising or publicising information on clinical trial capabilities could give potential sponsors and clinical trial
participants vital information to enable them to make informed decisions about conducting or participating in a
trial at that site. Including, but not limited to:
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disease specialisations;
research priorities;
trial phase expertise;
patient demographics;
staff expertise, credentials and critical mass;
clinical trial costing policy;
participant recruitment strategy;
timeframes for research governance approval;
performance data on clinical trials; and
Researcher credentials, such as publications and advisory roles.
Please rate importance: ☐ Critical ☐ Important ☐ Minor importance ☐ Not important
Other comments:…………………………………….
Additional Criteria:
Please detail any additional criteria, and rate using the below scale.
☐ Critical ☐ Important ☐ Minor importance ☐ Not important
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Providing your response
PLEASE PROVIDE YOUR RESPONSES TO THE CONSULTATION QUESTIONS VIA THE
NHMRC ONLINE CONSULTATION PORTAL AT http://consultations.nhmrc.gov.au/
UNCLASSIFIED
Page 6