• Many Matters of Time For Circadian Rhythm Research

    Clinical Research News | Growing appreciation in the research community about the impact of when we sleep, eat, and take our medicines has resulted in more interventional clinical trials aimed at correcting disturbances in the body’s complex of circadian clocks. It’s difficult work with potentially far-reaching implications for everything from losing weight and preventing preterm births to treating diabetes and prolonging survival from devastating cancers.

    Mar 30, 2020
  • Why the Clinical Trial Industry Needs Dynamic and Inclusive Marketplaces

    Clinical Research News | Over the past decade, digital marketplaces have emerged as a transformative business model. It’s time to reinvent the expensive, inefficient and biased clinical trial process; maybe marketplaces are the answer.

    Mar 27, 2020
  • WHO Malaria Vaccine ‘Rollout’ In Africa Raises Ethical Questions

    Clinical Research News | The large-scale Malaria Vaccine Implementation Programme (MVIP) of the World Health Organization (WHO) has ignited debate within the bioethics community about whether it is really a cluster randomization study that has seriously breached international ethical standards by failing to obtain informed consent from the parents of children opting for vaccination.

    Mar 26, 2020
  • Using Digital Health Technology to Address Payer Concerns About Data Capture

    Clinical Research News Contributed Commentary | In recent years, several pharmaceutical companies have shifted their research and development to target personalized medicines including novel cell and gene therapies, many of which offer the prospect of first-time treatments and even curative benefit for patients. While these therapies represent important and historic advances in medicine, they also require regulators, healthcare providers (HCPs), payers, and manufacturers to consider new value-based care principles and payment models to enable their commercialization and affordability.

    Mar 26, 2020
  • Working Out Treatment Timing

    Clinical Research News | People who have erratic schedules seem to suffer more with many diseases, including certain cancers, and women with irregular sleep-wake patterns are also at heightened risk for preterm birth, says Erik Herzog, a neuroscientist and professor at Washington University as well as president of the Society for Research on Biological Rhythms (SRBR). Working with OB-GYN researchers at Washington University, his lab found similar and reliable changes in the daily rhythms of both women and mice during pregnancy.

    Mar 25, 2020
  • Researchers Puzzling Over The Body’s Rhythmicity

    Clinical Research News | Circadian medicine gained newfound attention in 2017 when three scientists were awarded the Nobel Prize in Physiology and Medicine for their discovery of the molecular mechanisms controlling how time is measured in biological systems. But the backstory on the field goes back decades, including the 1997 discovery and cloning of the first circadian clock gene in mammals.

    Mar 24, 2020
  • Clinical Data Sharing for AI: Proposed Framework Could Rouse Debate

    Clinical Research News | A group of doctors from Stanford University has proposed a framework for sharing clinical data for artificial intelligence (AI) that could set off a firestorm of debate about who truly owns medical data, ethical obligations to share it, and how to properly police researchers who use it. On the other hand, the envisioned approach has parallels to the open science tactics currently being uniformly deployed to battle the COVID-19 pandemic.

    Mar 24, 2020
  • New Paths Ahead for Circadian Medicine

    Clinical Research News | A growing body of evidence suggests there are multiple health benefits to working with, rather than against, the body’s natural circadian rhythms—starting with when we eat, sleep, and take our medicines. Basic science research and observational studies have long dominated the literature, but more interventional trials are now getting underway aimed at correcting disturbances in biological timing triggered by disease, advancing age, and always-on modern lifestyles, as well as optimizing outcomes based on treatment timing.

    Mar 23, 2020
  • Three Ways Clinical Trials Will Be Enhanced In 2020

    Clinical Research News Contributed Commentary | New methods for collecting, analyzing, and sharing clinical trial data are needed in the era of personalized medicine. Beginning this year, we’ll see new trial designs being introduced that recognize a larger, broader section of the patient population.

    Mar 18, 2020
  • Making the (Regulatory) Grade With Real-World Data

    Clinical Research News | How to assess the quality of real-world data (RWD) for research purposes and apply it in real-world scenarios to add efficiencies to clinical trials and support claims about drug product effectiveness were top topics of interest at the recent Summit for Clinical Ops Executives (SCOPE) in Orlando. Many providers in the fast-growing RWD landscape are focused on a specific therapeutic area, including Flatiron Health. In addition to offering an oncology-specific electronic health record (EHR), the company has partnered with the U.S. Food and Drug Administration (FDA) to find ways to integrate EHR-derived evidence into regulatory decision-making.

    Mar 12, 2020
  • Novel Digital Endpoints: Adoption Holdups Include Device Variability, Managing Change

    Clinical Research News | Novel digital endpoints, including motion-detecting sensors and electronic patient-reported outcomes, hold tremendous promise for advancing precision medicine, expanding the reach of clinical research and reducing the burden of study participation. But adoption is being slowed by the abundance of tools and measures, sponsor inexperience with the technologies, and unfamiliar risks that software introduces into trials.

    Mar 11, 2020
  • Using Real-World Data In Rare Disease Research

    Clinical Research News | Agencies around the world hold highly consistent views on the use of real-world data (RWD) to support regulatory decision-making—especially when it comes to synthetic control arms in rare disease studies. The barriers have less to do with regulators than data access, quality, and completeness and the technical skills required to harmonize, link and enrich disparate datasets, based on a pair of case study presentations made at the 11th Annual Summit for Clinical Ops Executives (SCOPE) in Orlando.

    Mar 10, 2020