Expert Insights On Data Management & Analysis

81. How Do You Determine If RWE Is A Good Fit For Your Org? Ask (And Answer) The Right Questions 6/5/2023

    Real world evidence (RWE) is being heralded as a way to enrich our clinical data and lower the barriers to reimbursement. It also carries the potential of reducing the patient burden and lowering the cost of clinical data acquisition. But before getting to the point where we can reap the promises of RWE, we face a number of challenges as an industry. 

82. Considerations For Compliance With CTIS Submissions Under The EU-CTR 5/31/2023

    This article outlines the process for sponsors in transitioning from an EU-CTD to an EU-CTR CTIS submission process. It provides guidance on redacting both personal data and confidential commercial information (CCI) appropriately, with detailed advice on how to identify and assess CCI for redaction, as well as strategies for minimizing the risk.

83. From Big Pharma To Nonprofit: 3 Learnings In Building Biostatistics++ Teams 5/19/2023

    Biostatistics++ teams involve data management, programming, bioinformatics, epidemiology, and medical writing, and they have a unique position in clinical research and clinical trials. This expert offers advice based on her experience of more than two decades building biostatistics++ teams for Big Pharma, small biotech, and nonprofit orgs.

84. Understanding Data Collection And Management In Decentralized Clinical Trials (DCTs) 5/18/2023

    When it comes to wading into the muddy waters of a DCT, it's important to specify the risks up front and determine how decentralization is appropriate for each protocol. From a data collection and management standpoint, there is plenty to consider in terms of data flow management through multiple sources and systems.

85. Patient-Powered AI Is Driving Science And Innovation Forward 5/17/2023

    Drug discovery is a game of information: If we understand disease well, we know where to intervene and how to design a molecule to target the disease. AI can be used to integrate the patient experience and voice into solutions, further enhancing their relevance. 

86. Speed Up, Collect More, And Reach Further: Using RWD To Optimize Your Clinical Trials 5/10/2023

    The benefits of real-world data (RWD) have been so promising, the FDA now recognizes RWD — and corresponding real-world evidence (RWE) — as valid tools for monitoring the safety of products post-market and, in some cases, for making regulatory approval decisions. At Freenome, we first integrated the use of RWD during a clinical study launched in 2022 for the early detection of multiple cancers. Along the way, we’ve discovered several benefits RWD can bring to any clinical research program.

87. Why Developing A Metrics-Driven Culture Is A Clinical Operations Must-Do 4/14/2023

    The number of systems used to support the conduct of clinical trials has increased and the amount of data used to monitor our portfolio, studies, and processes has soared. While there is still value in using traditional dashboards and reports, the use of advanced analytics and RWD/E is enabling us to ask more sophisticated questions to be more predictive — what will happen — and prescriptive — how to make it happen.

88. AI And Healthcare Disparities: Driving A Wedge Or Closing The Gap? 3/31/2023

    The enthusiasm for the role of AI in upgrading global health and care provision is justified, provided we understand that the path to success is just as much about communication and collaborative development as it is about the raw potential of the technology itself. Because realizing this technological potential requires us to consider the role of people and processes in an integrated approach.

89. The CDISC Open Rules Engine (CORE): Open-Source Software For Clinical Trials 3/29/2023

    Open-source software development, widely used across most industries globally, has recently been gaining ground in clinical research. Discover how CDISC's Open Rule Engine (CORE) can make sharing standardized data sets easier and improve your workflow.

90. Unlocking The Potential Of RWD: Validating Prevalence Estimates For Rare Diseases 3/27/2023

    Real-world data (RWD) has proven to be valuable in studying rare diseases. Incorporating RWD has led to the identification of previously undetected cases and the monitoring of treatment outcomes. However, challenges such as the lack of standardized data collection and analysis methods still exist. To replicate successes, researchers should collaborate to establish standardized protocols, thereby advancing our understanding of rare diseases and improve patient outcomes.