Expert Insights On Data Management & Analysis

91. Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny 3/27/2023

    We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.

92. What Core Outcome Sets Can Do — If We All Adopt Them 3/22/2023

    A single trial provides just a snapshot of evidence. Many trials provide a summative account of how effective an intervention can be. But when the selected outcomes are different from trial to trial, it becomes much more challenging to reach a conclusion. Stuart Nicholls of the Ottawa Hospital Research Institute advocates core outcome sets as the remedy.

93. TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability 3/20/2023

    There is a growing desire within the clinical trials industry for better data integration — not just to help regulators, but also to help sponsors manage trials more effectively. The recent affiliation of the TMF Reference Model with the Clinical Data Interchange Standards Consortium (CDISC) may become key to making this possible.

94. Dispelling 4 Common Myths Of Data Quality Governance 3/9/2023

    Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.

95. Are Baseline Measurements Reliable? How RWD Can Help 3/6/2023

    Baseline measurements presume to establish physiological and/or metabolic status before introduction of test drug(s). But what if they aren't truly reflective for a particular patient? Introducing real-world data (RWD) might be the answer for improved accuracy.

96. 4 Pitfalls To Avoid When Starting Your AI/ML Journey 2/16/2023

    With the transforming artificial intelligence (AI) landscape in conducting clinical trials, it is important your company take action to maximize your returns. Identify a small number of high-impact AI use cases and prioritize these use cases based on feasibility within each department, and avoid these four key pitfalls.

97. FDA Seeks Comment On Design And Data Considerations For Externally Controlled Trials For Drugs, Biologics 2/15/2023

    On Feb. 1, 2023, the FDA released a new guidance, "Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products," for public comment. It provides recommendations to sponsors and investigators, addresses considerations for the design and analysis of such trials, and more. Submit comments to the FDA by May 2, 2023.

98. The 5Vs Of Collecting Clinical Data 1/26/2023

    Not all data is created equal. Our data strategies need to be commensurate with the risks, complexity, and value of the data collected. If the true value of data is to be realized, it must be collected and captured in accordance with the five “V” dimensions: volume, variety, velocity, veracity, and value.

99. Embracing Agility In Phase 2 Clinical Trials 1/19/2023

    Phase 2 clinical trials are like software development. How so? Ivanna Rosendal explains the connection and makes the case for using a now-ubiquitous software development workflow to improve clinical data management.

100. 2 Key Areas To Leverage AI/ML For More Successful Clinical Trials 1/3/2023

     Artificial intelligence (AI) and machine learning (ML) can be used to minimize errors in clinical trial participant management and streamline data management. However, realizing the full potential of this technology will require overcoming issues such as data quality/access, transparency of development and validation processes, and potential data bias.