Ancillary study management systems: a review of needs

Area of Science:

• Biomedical research informatics
• Clinical trial management
• Data science in healthcare

Background:

• Ancillary studies utilize existing clinical trial data and specimens to address new research questions efficiently.
• Managing these follow-on studies is complex, involving multi-institutional coordination and diverse data integration.
• Current literature lacks exploration of general-purpose software for ancillary study management.

Purpose of the Study:

• To identify requirements for ancillary study management systems (ASMSs).
• To guide the development of software simplifying ancillary study conduct.
• To enhance the efficiency and reduce errors in ancillary research.

Main Methods:

• Requirements were identified through work with major research consortia (CHAVI, ITN, HVTN, MHRP, nPOD).
• Consultations with other disease research organizations and review of their process documents were conducted.
• Characteristics of ancillary studies were explored to define system needs.

Main Results:

• Ancillary studies present unique requirements, including new specimen analyses, investigator-initiated studies, cross-protocol data pooling, and use of pre-existing consent and data.
• Ancillary Study Management Systems (ASMSs) must address operational needs like specimen allocation and data management for secure distribution and integration.
• Differentiating characteristics necessitate tailored system functionalities for effective management.

Conclusions:

• Defined scenarios and requirements can facilitate the development of user-friendly, cost-effective, and reliable ASMSs.
• General-purpose ASMSs are valuable for diverse organizations due to consistent ancillary study challenges.
• An open-source, general-purpose ASMS is being developed based on LabKey Server in collaboration with research consortia.