Clinical Trials

  1. How The FDA Views Natural Language Processing

    According to speakers at an FDA workshop, natural language processing (NLP) can be a useful way to extract meaningful information from unstructured data, such as text and tables from electronic health records (EHRs), journals, and social media, but it isn’t ready for full-scale use.

  2. Alternatives To Funding Lower-Priority Trials

    While some pharma companies struggle to backfill their pipelines, others find the opposite, that they have more development opportunities than they can pursue. While this may seem to be a nice problem to have, it also means that otherwise good drug candidates may be pushed down the list of priorities.

  3. Patient-Centricity — Answering Industry’s Key Questions

    The adoption of patient-centric processes is still so new that no standards or best practices exist yet. Here we present research from the Study of Patient-Centric Initiatives in Drug Development.

  4. Genentech Masters Breakthrough Therapy Designation

    Genentech has garnered 15 Breakthrough Therapy Designations for its medicines since 2013, which is more than any other company. Jeffrey Siegel, senior group medical director for Genentech, believes this success reflects the company’s focus on developing new approaches to address unmet medical needs.

  5. Tackling The Challenges Of A Rare-Disease Clinical Trial

    Regulatory agencies today are looking for Phase 3 trials to demonstrate a reduction in mortality as well as greater patient mobility. Unfortunately, Phase 3 trials also cost a lot of money to run, making them a challenge for small biotech firms.

  6. Janssen Turns Clinical Data Over To Patients

    Andreas Koester, MD, Ph.D., global head, R&D operations innovation at Janssen, discusses how the company is attempting to make patient data available to participants while a clinical trial is underway.

  7. How Patients Will Revolutionize Next-Generation Clinical Research

    Often when we think about inefficiencies in the clinical trial process, we focus on the role of the sponsor or CRO, a particular aspect of the value chain, or new technologies that promote data sharing and faster decision making. While these are critical aspects that drive day-to-day operations, there is another aspect of the value chain that we may be neglecting: the patient side.

  8. Considerations For The Use Of Wearables In Clinical Trials

    With wearables, we now have the means to innovate the “where” and the “how” of patient data capture, creating a 24-hour digital map of physical behaviors.

  9. Janssen Uses Trial Simulations To Capture Patient Concerns

    Bert Hartog, Ph.D., innovation leader, in R&D Operations Innovation at Janssen Research & Development, has a plan in place to make trials more patient-friendly. Janssen’s goal is to incorporate the patient voice into clinical research, make patients a partner in the research process, and ensure all future collaborations are a two-way street.

  10. Leveraging China Innovation For Worldwide Growth

    When you talk to Dr. Mireille Gillings, the founder and executive chair of HUYA Bioscience International, her enthusiasm and passion for drug development is clearly evident.