For over three decades, CTSU has developed systems that have facilitated the conduct of large-scale clinical trials and observational studies. These systems are founded on, and enhanced by, CTSU’s work in streamlining, focusing on those aspects that are most important to study quality: (a) recruitment of large numbers of eligible individuals; (b) data collection and study conduct; (c) study management, coordination and oversight; (d) laboratory management (including analysis and storage); (e) ascertainment, confirmation and classification of outcomes; and (f) analysis, reporting and dissemination.
The strategy has been to use the demands of new and on-going studies as a stimulus for new development that is specific to the immediate requirements but sufficiently modular, adaptable and generic to provide a platform for future studies. For example:
- Recruitment and appointment systems developed for UK Biobank (based on, but significantly modified from, previous experience in HPS and SEARCH) allowed the generation of several hundred thousand invitations for the THRIVE and REVEAL trials
- Enhancements to the data entry system for the THRIVE study were critical in enabling rapid deployment of data collection systems for the REVEAL trial
- Systems for participant management, mailing and data collection originally designed for ASCEND have been adapted to support other trials
- Systems for drug supply, coordination, blood kit production and optical archiving initially developed for SHARP now support the REVEAL trial
- Integrated devices for measuring bioimpedance, spirometry and pulse wave velocity developed for UK Biobank are now being redeployed for the China Kadoorie Biobank
- Systems for adjudicating reports of cardiovascular and cancer events developed for the SEARCH trial are now being used in the ASCEND trial; and
- Analysis systems initially deployed in the HPS trial were extensively modified for the SHARP, THRIVE and REVEAL trials
Our IT systems comply with relevant security and data privacy policies and regulations (including EU Data Protection Directive 95/46/EC, and US Health Insurance Portability and Accountability Act (HIPAA) 1996) as well as, where appropriate, standards for clinical trial systems (including US Code of Federal Regulations Chapter 21 Part 11 “Electronic Records and Signatures” and EU Clinical Trials Directive).