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Clinical trials and cohort studies


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Presentation by Dr Davina Ghersi, NHMRC, to the 'Unlocking value from publicly funded Clinical Research Data' workshop, cohosted by ARDC and CSIRO at ANU on 6 March 2019.

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Clinical trials and cohort studies

  1. 1. Clinical Trials and Cohort Studies Davina Ghersi SPRS
  2. 2. 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.
  3. 3. 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
  4. 4. 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.
  5. 5. 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 a cohort. • 1/3 are children or infants
  6. 6. 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 requirements) Registration of cohort studies is strongly encouraged but is not currently a requirement.
  7. 7. 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 supported research.
  8. 8. 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.
  9. 9. 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.