Journal: BMC Medical Informatics and Decision Making

Article Title: Ancillary study management systems: a review of needs

doi: 10.1186/1472-6947-13-5

Figure Lengend Snippet: ASMS data flows. This figure shows a conceptual model for data flows for ancillary studies whose primary focus is analysis of stored specimens. In this scenario, data flows into the ASMS from the primary study’s CTMS (which contains information on participants, visits, consent and other pre-existing data) and specimen repository LIMSs (Laboratory Information Management Systems, which contain information on stored specimens available for further investigation). Before an ancillary study is initiated, the ASMS is used for hypothesis generation and feasibility investigations based on specimen availability. Once a particular ancillary study has been identified, a container for its data is established within the ASMS. After the ancillary study has been approved, any additional participant consents required for the study are collected by clinical sites and noted in the ASMS. Requests for needed specimens (including material transfer agreements) are sent to the appropriate specimen repositories, which in turn send stored specimens to appropriate labs. The labs perform assays on the specimens and import the results to the ancillary study container in the ASMS. Once the ancillary study is complete, results may be repatriated to the primary study. Results may also be shared in publications or other venues. This model presumes that all data for the ancillary study is managed within the ASMS, not the CTMS or an external system. It also presumes that external investigators can be given access to the study within the ASMS. Under different assumptions, usage patterns and data flows would change, but an ASMS could still prove helpful. For example, if gathering new clinical data from study participants is a significant piece of an ancillary study, using an organization’s existing CTMS for collecting and managing clinical data might make the most sense. An ASMS could still be desirable for other aspects of the study. For our collaborators, CTMSs have not proven amenable to the kinds of queries necessary for hypothesis generation and participant identification. Also, they are not ordinarily well-integrated with relevant LIMSs, so they do not facilitate identification of specimen availability. An ASMS could be used for these steps and others that are not typically supported by CTMSs or LIMSs, such as specimen requests and assay data management.

Article Snippet: In collaboration with CHAVI, the ITN and nPOD, we are currently developing a general-purpose, open-source ASMS based on the LabKey Server system.

Techniques:

Journal: BMC Medical Informatics and Decision Making

Article Title: Ancillary study management systems: a review of needs

doi: 10.1186/1472-6947-13-5

Figure Lengend Snippet: Virtuous cycle feedback loops. Using existing results and materials to refine hypotheses and develop new insights can produce “virtuous cycles,” where the research efforts of today feed tomorrow’s discoveries. Figure shows two kinds of such cycles that are implied by the ancillary study workflow described here. An ASMS can facilitate both types of cycles by smoothing the flow of information, enabling collaboration, simplifying workflows and allowing researchers to make the most of existing materials and information. (i) Full study cycle. The nine steps in the ancillary study workflow form a virtuous cycle that spans the full life of a study, from the first glimmer of an idea through publication. For simplicity, Figure breaks these steps into three phases (study initiation, study execution, and results sharing). These steps are roughly equivalent to those that form the “inner,” study-based loop in Kahn and Weng’s conceptual model for clinical research informatics . In such cycles, published hypotheses and shared data from completed studies are used to generate future discovery cycles by providing inspiration and ingredients for follow-up studies. (2) Incremental review cycles. An ASMS can also facilitate smaller-scale virtuous cycles during all phases of an ancillary study. First and foremost, during the study initiation phase, the information and tools made available by an ASMS allow incremental refinement of hypotheses and study plans according to existing data, specimen availability, and consent limitations. During later phases of a study, an ASMS can make it easier to share and review new information as it is collected, allowing feedback of new insights into study investigations, operations, analyses, and conclusions. Of course, in-progress studies governed by clinical trial regulations will provide less scope for immediate use of this type of feedback than the kinds of pre-clinical, exploratory studies common among our collaborators.

Article Snippet: In collaboration with CHAVI, the ITN and nPOD, we are currently developing a general-purpose, open-source ASMS based on the LabKey Server system.

Techniques: