Open Access to Clinical Trial Data
The open access to clinical trial data conversations recently reached our Australian screens when Catalyst discussed Tamiflu on March 3rd and concerns from Cochrane Collaboration reviewers around Roche's reported cherry-picking of data. While high profile cases around data disclosure have been typically focused on pharmaceutical industry, the broader conversation around open access to data has strong implications for investigator initiated research.
NHMRC requires all funded trials register before commencing, as well the Open Access Policy which states that "publications that have resulted from NHMRC-supported research need to be placed in an open access repository within twelve months of that publication being published".
These policies mirror the principles of AllTrials who aims to have "all past and present clinical trials registered and results reported". Since its launch in January 2013 it has attracted 83073 signatures and 544 organisations. In November last year NHMRC announced its support for the AllTrials campaign joining others such as Australian Medical Students' Association, Consumers Health Forum of Australia, and Medical Journal of Australia.
The next stage for NHMRC is the Draft Principles for Accessing and Using Publicly Funded Data for Health Research. It has the "ultimate aim of improving the quality of public health and health services research in Australia" by providing a framework of "principles for researchers and data custodians to consider when requests or applications are made for access to existing health and health-related datasets for research purposes". Targeted consultation submissions have recently closed (Feb 16th).
The targeted consultation was established to determine its suitability for the target audience, "researchers using publicly funded health and health-related datasets", and how to best implement it across Australia. Australian Clinical Trials Alliance has responded with suggestions such as the need to define which activities fall under 'safety and quality' vs. 'research' so that data custodians and researchers can distinguish how these principles will apply for integrated activities such as registry-nested trials and long-term follow ups. They have also highlighted that there is no definition about what would be considered 'meritorious' or 'eligible' research and eligible researchers, something of particular importance in light of high risk identifiable data.
These are early stages for the Draft Principles for Accessing and Using Publicly Funded Data for Health Research and we would like to express our appreciation for those who have contributed responses to NHMRC as well as NHMRC for taking an open and consultative approach in developing this policy.
Research Path supports AllTrials through staff individual commitments to the campaign as well as through donations. We work predominantly in the field of investigator initiated research and believe in the power of access to data to improve public health research quality and outcomes.
We will stay up to data with how the Draft Principles progress to ensure our software solutions and processes enable easy access and sharing of data for participating trials and registries in the future.
For more information on the AllTrials campaign visit: www.alltrials.net.