To review participants for inclusion in an ancillary study, investigators need to align, integrate and evaluate a range of data types, including consent, clinical, assay, and specimen.
In direct opposition to ancillary study investigators' need to accumulate new data, Good Clinical Data Management Practice (GCDMP) calls for the clinical trial database to be locked upon completion of the trial [ 60, 61], so data cannot easily be added.
Thus, future studies need to be designed to identify whether physicians and patients appropriately interpret and use risk scores or whether changes in outcomes are due to the presentation of ancillary information, particularly about risk factors themselves.
Furthermore, when data representation differs between primary and ancillary studies, these differences may need to be reconciled before data can be integrated (as described in Step 5 above).
Left-over specimens from the ancillary study may also need to be moved from labs, clinics, and external repositories into the central specimen repository for the primary study.
In contrast, with the exception of our own conference abstract [ 25], the research literature contains little discussion of systems (or system extensions) that specifically address the cradle-to-grave needs of ancillary studies.
We have previously reviewed open source systems for managing and integrating clinical and experimental data types; however, none of these platforms addresses the particular needs of ancillary studies [ 30].
Once data are retrieved, they need to be transmitted to ancillary study investigators, or external investigators need to receive access to the data on the sponsoring organization's data systems.
In the case of diabetes, databases on body composition, strength, and function in large clinical series of patients are greatly needed and might be feasible ancillary studies to the many existing multicenter observational and intervention programs.
A further wrinkle unique to ancillary studies is that data funded and obtained by external investigators may need to be marked as embargoed for use by other investigators for some period of time.
