Expert Insights On Data Management & Analysis

  1. An Overview Of FDA Efforts To Encourage DHT Use In Drug & Biological Product Development 10/30/2023

    The FDA issued its Framework for the Use of Digital Health Technologies in Drug and Biological Product Development earlier this year, representing the agency's road map on the topic. Digital health technologies (DHTs) may include wearable, implantable, or software applications, among other approaches. This article takes a closer look at the framework as well as related FDA efforts this year.

  2. Key Considerations For Cell & Gene Therapy Developers To Tap Into AI 10/24/2023

    In the authors' first article in this two-part series, they discussed the opportunities for AI to assist cell and gene therapy companies. In this second article, they examine how cell and gene therapy developers can wisely harness AI, with a look at outsourcing vs. developing in-house solutions, data acquisition strategies, the three stages of managing AI/ML algorithms, and more.

  3. How To Balance Data Privacy And Sharing: A New Methodology For Clinical Data Reuse 10/18/2023

    The TransCelerate BioPharma consortium is proposing a new methodology to enable secondary use of primary health data. Included are best practices that help increase transparency around the privacy safeguards used on trial data, increase data utility for the reuse of existing trial data, and protect patient privacy.

  4. Future Funding, Trial Success Necessitates Use Of AI 10/12/2023

    Integrating AI enables sponsors to design better clinical trials, researchers to refine their subjects more effectively, and investors to allocate resources more productively. Here, Garri Zmudze discusses implications for AI in clinical research and how funding will follow its integration.

  5. Opportunities For AI To Assist Cell & Gene Therapy Companies 10/10/2023

    Although AI/ML is still in a nascent stage in the cell and gene therapy sector, it has an enormous amount of potential to transform overall business models, early R&D, clinical trials, manufacturing and operations, and regulatory compliance support in these key ways.

  6. Secondary Use Of Primary Health Data In A Clinical Trials Digital Revolution 10/6/2023

    LongeVC managing partner Sergey Jakimov discusses how primary health data, when synergized with cutting-edge digital solutions, is set to revolutionize clinical research.

  7. Patients Need Faster Access To Approved FDA Vaccines. What Can We Do? 8/17/2023

    There are times when a significant lag between the FDA approval of vaccines and the Centers for Disease Control and Prevention (CDC) recommendation of those vaccines throws any newly approved vaccines into patient access purgatory. What can vaccine developers do during the clinical trial phase, and what can other stakeholders do, to help influence a shorter lag?

  8. How Can Non-randomized RWE Studies Complement RCTs? 8/4/2023

    While RWE can provide deep insights into the drug development process, inform regulatory decisions, and supplement clinical research, it does have its limitations. Researchers with the RCT-DUPLICATE Initiative have emerged with key learnings to further inform the industry on the capabilities of RWE.

  9. Designing Quality Into Your TMF: ICH E6(R3) And Advancing Trial Efficiency 7/17/2023

    The May release of the International Council for Harmonization (ICH) draft guidance E6(R3) for public review and comment has inspired optimism that its implementation could lead to more efficient trials. Could implementation also improve trial master file (TMF) quality in support of greater efficiency?

  10. No More XPT? Piloting New Dataset-JSON For FDA Submissions 7/12/2023

    CDISC has developed Dataset-JSON, a new dataset exchange format, to replace XPT. Working with the FDA and industry participants, CDISC and PHUSE are leading a new pilot project to test Dataset-JSON for use in regulatory submissions as well as other dataset exchange scenarios.