What is a clinical trial
What is a clinical trial? (WHO definition)
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.
NHMRC investment in clinical trials
NHMRC funds on average 55 clinical trials through Project Grants
(MREA only) each year.
The median project grant for a clinical trial
• 2010 = $600,764
• 2015 = $1,303,735
What is a cohort study
Any study that identifies and follows a group of individuals that
share a common characteristic through time in order to measure
one or more health-related outcomes.
- Clinical cohorts: a type of cohort where participants are drawn
from a group with a specific disease or condition
- Population cohorts: assess the impact of risk factors or other
exposures on health related outcomes.
Australian cohort studies in health
• 148 identified
• 8 are core DSS data sets
• 100/140 appear to be ongoing
– 42/100 of the cohorts identified explicitly state that they
may make their data accessible to researchers outside of
the immediate research team.
– The remainder either don’t have a policy or explicitly state
that data is not accessible.
• Assuming all of the ongoing cohorts reach their target sample
size, approximately 3.5% of the Australian population will be in
• 1/3 are children or infants
NHMRC Registration policy
All clinical trials funded by NHMRC must be registered in the
Australian New Zealand Clinical Trials Registry (ANZCTR) or
equivalent before recruitment of the first participant. (CTCS scheme funding
Registration of cohort studies is strongly encouraged but is not
currently a requirement.
Open Access Policy
NHMRC acknowledges the importance of
making research data publicly accessible and
therefore strongly encourages researchers to
consider the reuse value of their data and to
take reasonable steps to share research data
and associated metadata arising from NHMRC
Data sharing policy
When sharing data, researchers should ensure that appropriate metadata
accompany the datasets. This will allow users of the data to fully understand
the data, the curation strategies, assumptions, experimental conditions and
any other details relevant to the interpretation of the data. When sharing
research data, researchers must also consider the appropriate level of
access that they would like to provide to users. The level of access may
range from highly restricted (e.g. commercial in confidence, patient level,
culturally sensitive, national security) to fully open access.
Data sharing policy
NHMRC acknowledges that sharing certain types of data may be complex.
An example would be sharing of clinical trial data due to the length of clinical
trials, the types of data inherent in clinical trials and the governance of the
data. NHMRC therefore encourages researchers to share clinical trial data
and associated metadata as soon as possible after publication provided that
all ethical, regulatory and legal obligations are fulfilled. In order for the data to
be of value to other researchers and for proper analyses to be conducted,
the analytical techniques, assumptions, software and other details relevant to
the clinical trial should also be shared alongside the data.