Consultative Support for Investigators
The Division provides consultative assistance by our faculty who are expert in research design, clinimetrics, behavioral science, clinical epidemiology, decision analysis, outcomes, and qualitative measurement to investigators who request it.
A few areas that our faculty are uniquely able to provide methodological guidance include:
- developing new instruments to measure severity, function, satisfaction, expectations, and outcomes
- designing studies to reduce health disparities in underserved communities using community-based participatory research strategies
- developing new behavioral strategies to preserving health and improving quality of life
- developing innovative methodological strategies for clinical trials and new methods of identifying participants for studies
- developing qualitative components for prospective studies
Informatics Support for Investigators
Until the era of genomics, proteomics, and metabolomics, most basic science investigators did not require any data system support. Data points generated were analyzed using relatively straightforward techniques and data was stored in simple databases. Many translational investigators, who had their foundational experience in basic science laboratories, built on those experiences to develop databases and spreadsheets for their data from widely available commercial applications. In general, that was sufficient. Clinical investigators who worked on single center studies had to find the easiest ways to create data management tools. For almost all studies, "one time" databases or spreadsheets were generated. The more complicated the study, the more problems arose downstream when it was time for analysis. Problems run the gamut from duplicate entry, to missing or miscoded data, logical inconsistencies, failure to notice protocol violations, or failure to document outcomes in a timely fashion. Even when data was collected on standard forms and sent to sponsors (either commercial sponsors or the NIH or VA for multicenter trials), errors of omission and commission still occurred.
Given these realities, we began to develop a web-based data management system, ClinVestigator, that met all security requirements and could be used as a universal foundation for a variety of clinical investigations. The ClinVestigator project is an open-source data collection, reporting, and analysis web-based tool for clinical and translational research. Its focus is on usability, reliability, security, and speed. The advantages of web-based real time data entry systems are substantial. They eliminate the need for data entry as a separate step which speeds project turn-around time and provides help screens which make it easier to train data collectors to record data uniformly. They permit real-time validity, logic and completeness checks of data, which increase accuracy and simplify the accurate handling of complex skip patterns. ClinVestigatoris form-driven with pre-built forms, but it also allows users to build custom forms. It has a large and growing library of pre-built forms/standard measures that investigators can select to use in their studies. The scores for these questionnaires are calculated automatically and stored in the database with the patient responses.
The Division's informatics faculty expands and customizes an already established flexible scalable platform to meet the needs of investigators who wish to use it. The faculty provides central data system support through the ClinVestigator system and providing specific data management tools for specific research initiatives. Each new study must have its own unique protocol and specific data requirements and each must also comply with requirements mandated by, among others, the IRB, HIPAA, FDA, and the NIH. Needs such as long term data caching and sharing, electronic signatures, complete audit trails, interim analyses for progress reports and safety monitoring are common to almost all studies. The faculty thus needs access to a flexible data system that will comply with these requirements and facilitate data capture, including interfaces to existing clinical systems (inpatient and ambulatory electronic medical records, ancillary systems such as labs and radiology both internally and externally). The data system needs to be rapidly configurable and needs to incorporate data analytic strategies. If problems develop we can correct them quickly because we can reach "under the hood."
A key feature of ClinVestigator is its ability to generate custom real time and dynamic reports. The most common report tracks patients follow up visits and scheduling. These reports are employed by the investigators and their project staff to manage day to day protocols. The dynamic reports track the overall progress of studies including patient accrual and eligibility; completeness of data; timeliness of data acquisition; compliance with protocol procedure and completeness of follow-up. The reports are used to organize follow up by research assistants. Separate schedules are all up to date in the system. The reporting features of ClinVestigator are its most-used feature. Reports are customized for each study at its inception, and can be accessed by investigators utilized at any time. The system also streamlines adverse event reporting. These features are key to study efficiency, and significantly reduce the requirements for research staff on the project, and increase adherence to study protocols. By providing high quality informatics support, the Division assists investigators to efficiently and effectively acquire and manage data and thus to be more competitive for external funding. Such a data management system that has been shown to work is critical to success in NIH peer review for investigator initiated clinical trials or prospective studies.
Key features of ClinVestigator are:
- Direct patient entry of data
- New methods of data capture
- Registries/biological repositories
Division of Clinical Epidemiology and Evaluative Sciences Research
Mary E. Charlson, MD, Chief
Suzan Toro, Administrator
338 East 66th Street
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