• Data Privacy And Patient-Centeredness Driving Technology Adoption

    Clinical Research News | The potential of artificial intelligence (AI), internet-connected devices, wearables, and cloud computing to disrupt traditional clinical trials was explored during a presentation on patient-centered endpoints at the recent DIA 2021 Global Annual Meeting. The common goal is to make studies more palatable for participants, improving their engagement and retention, and to help pick up the pace and cost of making new medicines.

    Jul 26, 2021
  • 5 Reasons Why a Decentralized Method Works for Clinical Trials

    Clinical Research News | With sponsors like IQVIA, Pfizer, and GSK joining the Decentralized Trials & Research Alliance and the FDA giving decentralization its nod of approval, it’s safe to say the clinical research industry will continue to embrace decentralized trials.

    Jul 23, 2021
  • Building Trust In Real-World Evidence

    Clinical Research News | Lessons learned to date about the growing use of real-world evidence (RWE), including emerging approaches to improve study design and the measurement of treatment effects, were highlighted during a presentation by regulatory and pharmacoepidemiology (PE) experts at the recent DIA 2021 Global Annual Meeting. The wide-ranging conversation touched on everything from the regulatory context in which RWE is being used and whether clinical questions can be reliably addressed to the quality of real-world data (RWD) sources and more rigorous methodological approaches that might be adopted to help ensure confidence in study findings.

    Jul 21, 2021
  • Overcoming Barriers To Using Artificial Intelligence In Clinical Research

    Clinical Research News | Current and potential uses of artificial intelligence (AI) and automation in clinical research, and ways to overcome common barriers, were discussed by a panel of industry experts at the recent DIA 2021 Global Annual Meeting. Two multi-stakeholder communities of practice groups now meet regularly to explore ways to leverage AI and machine learning (ML), one focused on improving trial quality and cycle times and the other producing high-quality protocols and reducing risks before the start of a study.

    Jul 20, 2021
  • 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
  • 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
  • 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
  • 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
  • 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