• 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
  • Why AI is a Game Changer for Pharmacovigilance and Safety

    Clinical Research News | When new drugs, vaccines, and medical devices are developed and enter the market, one of the most important things to address is safety. The secret weapon in this data battle is automation and artificial intelligence (AI).

    Jul 7, 2021
  • The How-Tos Of Accelerating Digital Transformation In Pharma

    Clinical Research News | At Almirall, a novel Digital Garden accelerator program for startups with digital health technologies is measuring success not by traditional operational metrics but on having high achievers from across the organization mentor the startups and help embed an “entrepreneurial way of working.” It is one of multiple stories about picking up the breadth and speed of innovation that will be shared during a fireside chat at next week's Clinical Research Leadership Forum being presented by the producers of the Summit for Clinical Ops Executives.

    Jul 6, 2021
  • Follow the Money: Digital Clinical Trial Protocols, AI-Powered Clinical Research

    Clinical Research News | Insilico Medicine closes a Series C for AI-powered drug discovery, while other investments fuel smart digital clinical trial protocols and an AI-powered clinical research platform.

    Jul 2, 2021