GOVERNANCE  

The Bi-national ASPREE Governance Board is responsible for governance of the project in accordance with the requirements of the funding bodies and their institutions. It also oversees policies related to data availability and access.

The International Steering Committee (ISC) was responsible for the overall management and conduct of the ASPREE Project in Australia and the USA. During the trial, this committee met quarterly, overseeing protocol implementation and adherence, financial management and study progress. Various sub-committees and sub-studies reported to the ISC.

The International Executive Committee (IEC) was a smaller committee derived from the ISC, that met twice a month. During the trial, this committee would oversee operational management, study and sub-study progress (including generation of reports), data access and publications. Various sub-committees and sub-studies reported to the IEC.

During the trial, the NIA (the major funding body for the project) appointed an independent Data Safety and Monitoring Board (DSMB) with the responsibility of monitoring quality control of the data, trial progress and safety aspects every six months during the ASPREE clinical trial.

During the trial, the independent Observational Study Monitoring Board (OSMB) appointed by the NIA and NCI, monitored retention and data quality and any new ancillary studies during the ASPREE-XT study.

Both boards reported to the NIA.

During the trial, the International Data Management Committee (IDMC) monitored the ASPREE data management processes in Australia and the USA. The IDMC reviewed data reports generated by the Data Management Committee (DMC) for completeness and quality. The IDMC Chair reported to the IEC on data management issues (apart from data access) associated with the study.

During the trial, the Data Management Committee (DMC) was responsible for the project’s web-based data system: overseeing programming and changes to the database and day-to-day management of the database and systems of data collection. The DMC prepared reports and interrogated the database to respond to queries from study investigators and managers, in addition to resolving issues relating to data capture and the database functionality.  It reviewed reports generated by the database and the data from the quality assurance program. The DMC reported to the IDMC.

The Bio-specimen Access Committee is responsible for review and approval of the use of ASPREE’s stored bio-specimens for genomics, biomarkers and any other analyses.

The Endpoint Adjudication Committee (EAC) evaluates ASPREE participant outcomes while still blinded to assigned treatment in the ASPREE trial (100mg aspirin or matched placebo).  Specialist sub-committees examine relevant clinical records to adjudicate specific endpoint outcomes of: dementia, cancer, cardiac events, stroke, cause of death, disability, depression and clinically significant bleeding.  Each sub-committee has members from Australia and the USA with expertise relevant to the clinical or health event to be adjudicated.

During the trial, the Australian Management Committee was responsible for implementing the project in Australia, monitoring study progress and ensuring adherence and standardisation throughout the study across the sites.

The Australian Operations Committee monitors and manages the day to day operations of Australian staff, ensuring compliance with the study protocol and objectives. Responsibilities include keeping study staff up to date on study procedures and activities, monitoring study conduct and providing instruction and refresher training. Operations meetings are held monthly and report to the Australian Management Committee.

The United States Operations Committee is responsible for implementing the study, monitoring progress, ensuring adherence and standardization throughout the many study sites in the United States. This committee ensures quality control review of laboratory data, clinical measurements and data collection, completeness of data and transfer of data to the Data Management Center, site monitoring and appropriate source documentation.

The Presentations, Publications and Ancillary Studies Committee (PPA) reviewed all publications and presentations borne from the ASPREE clinical trial and sub-studies.

Since 2020, Special Interest Working groups, oversee publications (data analysis and manuscript preparation), grant applications and future studies into aspects of health or disease in the ASPREE project. Each group reports progress of publications to the IEC.

Current Special Interest Working Groups include:

• Microbiome & ALSOP (Australian Longitudinal Study of Older Persons) sub-studies
• Cancer / sub-types
• Cancer genomics
• Cardiovascular disease/hypertension
• Dementia
• Depression
• Disability and frailty
• Genomics
• Medication use (Conmeds)