Below are abstracts for several of our free white papers. To access the full versions of our white papers, we request that your contact information be provided to receive occasional updates regarding Comprehend.
Cancer research continues to be a focal point for pharmaceutical companies, healthcare providers, regulatory bodies and other policymakers. As new laboratory technologies are developed, larger amounts of clinical data are generated. The increased volume of oncology data call for adequate infrastructure and intelligent ways to analyze information.
A revolutionary alternative to clinical data warehousing is needed. Virtual, on-demand data warehouses make this promise a reality enabling risk-based monitoring, cross-study executive insights to identify operational and clinical trends across trials independent of the data source or format providing insights through a cloud-based system.
The use of placebo as a methodological tool has assumed a leading role in clinical trials, which are the main elements of the "evidence-based-medicine" paradigm. The prevalence and magnitude of a placebo effect depend on how the placebo effect is measured, the characteristics of the condition being studied, and the experimental or clinical context in which the placebo is administered, among other factors.
Data standardization is often necessary to comply with data sharing requirements of public repositories, such as those of the NIH's National Center for Biotechnology Information, and for publication in peer-reviewed journals. Portable electronic medical records also require standardization, via protocols such as HL7. Ultimately, data standardization can be useful to enable statistical validity as well as clinical insight.
Many biological and clinical questions of interest are temporal in nature. These include clinical studies whose goals are to assess the time of onset of different treatments, to observe the effect of drug treatment over time, and to monitor the long-term safety of therapeutics. In this article, we discuss several important considerations involved in the analysis of temporal and longitudinal data, specifically related to framing a question, designing a study, analyzing data, and interpreting results. We also refer to several recent, real-world examples of these topics.
Site monitoring is an essential element of clinical trials, ensuring quality and integrity of a clinical investigation. Monitoring uncovers potential problems such as data entry errors or missing data, assures that study documentation exists, assesses the familiarity of the site’s staff with the protocol and required procedures, and provides a sense of the overall quality of a site.