Data management in clinical research

Display Omitted This study assessed data management needs in clinical research from multiple perspectives.Researchers view activities related to data manipulation as merely tactical.Researchers perceive tasks related to study execution, analysis and quality control as strategic.Software developers should provide better support for coordination and improving data quality. ObjectiveThis study assesses data management needs in clinical research from the perspectives of researchers, software analysts and developers. Materials and methodsThis is a mixed-methods study that employs sublanguage analysis in an innovative manner to link the assessments. We performed content analysis using sublanguage theory on transcribed interviews conducted with researchers at four universities. A business analyst independently extracted potential software features from the transcriptions, which were translated into the sublanguage. This common sublanguage was then used to create survey questions for researchers, analysts and developers about the desirability and difficulty of features. Results were synthesized using the common sublanguage to compare stakeholder perceptions with the original content analysis. ResultsIndividual researchers exhibited significant diversity of perspectives that did not correlate by role or site. Researchers had mixed feelings about their technologies, and sought improvements in integration, interoperability and interaction as well as engaging with study participants. Researchers and analysts agreed that data integration has higher desirability and mobile technology has lower desirability but disagreed on the desirability of data validation rules. Developers agreed that data integration and validation are the most difficult to implement. DiscussionResearchers perceive tasks related to study execution, analysis and quality control as highly strategic, in contrast with tactical tasks related to data manipulation. Researchers have only partial technologic support for analysis and quality control, and poor support for study execution. ConclusionSoftware for data integration and validation appears critical to support clinical research, but may be expensive to implement. Features to support study workflow, collaboration and engagement have been underappreciated, but may prove to be easy successes. Software developers should consider the strategic goals of researchers with regard to the overall coordination of research projects and teams, workflow connecting data collection with analysis and processes for improving data quality.