• MedVector To Connect Patients Of Local Physicians To Study Investigators

    Clinical Research News | A startup is positioning itself to be a key player in the burgeoning decentralized clinical trial (DCT) marketplace and has tapped industry innovator Craig Lipset, who designed and co-led the industry’s first fully virtual clinical trial, to be its executive advisor. MedVector is the first company to enable local, non-investigative physicians to access clinical trial medications as a care alternative.

    Jul 19, 2021

  • Studies Using External Control Arms Gaining Ground

    Clinical Research News | The willingness of healthcare authorities to accept external control arms (ECAs) in regulatory submissions depends largely on how and when they are used, according to real-world data (RWD) experts from Merck, Bristol-Myers Squibb, and Ikaika Health who presented at the recent DIA 2021 Global Annual Meeting.

    Jul 16, 2021

  • The Ultimate Patient-Centric Supply Chain

    Clinical Research News | A supply chain strategy that truly puts patients at the center requires a wide variety of trial services, delivered seamlessly. Improved patient access, reliability, customizability—all these things are incompatible with fragmented service and require the central coordination and end-to-end oversight only available from a comprehensive, single-source solutions provider.

    Jul 16, 2021

  • Sponsors Looking to Life Study Burdens Off Patients And Sites

    Clinical Research News | Changes required of study sites during the COVID-19 pandemic, and their evolving role in the clinical trial ecosystem, was the subject of a panel discussion at the recent DIA 2021 Global Annual Meeting. The need to give sites greater flexibility and respect—and for industry to collaborate to reduce the burden of studies on patients and sites and deal with Europe’s new data protection law—were among the main points of consensus.

    Jul 15, 2021

  • Practical Ideas For Improving Clinical Trial Diversity

    Clinical Research News | A panel of experts offered their insights on how to “fill the gaps” when it comes to diversity and inclusion in clinical trials at the recent DIA 2021 Global Annual Meeting. The lively and informative session was moderated by Clare Grace, chief patient officer at Parexel, filling the first such role in the CRO industry.

    Jul 14, 2021

  • Regulators Embracing ‘Fit-For-Purpose’ Patient Engagement

    Clinical Research News | Ensuring patient engagement methodologies are “fit for purpose” from the beginning was the topic of conversation among experts from Europe and the U.S. during the recent DIA 2021 Global Annual Meeting. The manner of engagement directly influences the quality of data collected.

    Jul 14, 2021

  • Experts Offer Tips On Combatting Health-Related Misinformation

    Clinical Research News | Misinformation is not a new concept, but it covers a lot of territory and can be tricky to combat, according to experts participating in a panel discussion on the topic at the recent DIA 2021 Global Annual Meeting. Intentional misinformation, sometimes termed “disinformation,” can be viewed as distinct from the larger body of misinformation that is unintentionally wrong or misleading but nonetheless contributes to poor decision-making.

    Jul 13, 2021

  • Regulatory Response To Pandemic Relies On Real-World Data Analysis

    Clinical Research News | A team of regulatory experts presented at the recent DIA 2021 Global Annual Meeting on COVID-19 real-world data (RWD) analysis and vaccine surveillance. Representatives from the U.S. Food and Drug Administration (FDA) covered the COVID-19 Evidence Accelerator, National COVID Cohort Collaborative (N3C) Data Enclave, and a study describing ethnic and racial disparities in COVID-related hospitalizations, while those from the Danish Medicines Agency focused on COVID-19 cohort data analysis related to post-infection complications and vaccine safety.

    Jul 13, 2021

  • Merck’s Retiring CEO Highlights ‘Durable Innovations’ That Pandemics Produce

    Clinical Research News | At his opening keynote address at the recent DIA 2021 Global Annual Meeting, newly retired Merck CEO Kenneth Frazier focused on the “durable innovations” predating the COVID-19 pandemic as well as those with staying power that have emerged over the past 18 months.

    Jul 12, 2021

  • Strategy For Reducing Blood Clots In Kids Put To Real-World Test At Vanderbilt

    Clinical Research News | Monroe Carell Jr. Children's Hospital at Vanderbilt has responded to the growing incidence of hospital-associated venous thromboembolism (blood clots) in kids by developing an algorithm to predict patients who are at high-risk in real time. A pragmatic clinical trial underway now is testing the effectiveness of a newly validated, general pediatric predictive model.

    Jul 12, 2021

  • Strep A Vaccine Development No Longer ‘A Bridge Too Far’

    Clinical Research News | In at least two, placebo-controlled randomized trials getting underway in the next year, participants will be purposefully infected with a strain of group A streptococcus (Strep A) causing acute pharyngitis (strep throat) in a human challenge test of candidate vaccines intended to confer protection.

    Jul 8, 2021