• 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

  • 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

  • Medable Launches Certification Program For Decentralized Clinical Trials

    Clinical Research News | At the DIA Global Annual Meeting yesterday, Medable presented on its recently established digital certification program for decentralized clinical trials (DCTs) intended to provide life science companies with the design tools and knowledge to scale their study strategies with more of the DCTs “building blocks”—ranging from televisits and eConsent to medication distribution and home nursing and labs.

    Jul 1, 2021

  • Tackling The Environmental Challenge Of E-Waste From Digital Health Devices

    Clinical Research News | Pharmaceutical leaders are being invited to join an emerging dialogue around ways to reduce the growing stream of electronic waste (e-waste) from digital health devices. The conversation has already been launched by some big-name players—Johnson & Johnson (J&J), Philips Electronics, the Waste Electrical and Electronic Equipment (WEEE) Forum, the United Nations Environment Programme, and the Copenhagen Business School among them—who agree on the need to holistically address the problem

    Jun 30, 2021

  • New Accenture Leadership for Medable, Consolidation Around Decentralized Trials, New Products

    Clinical Research News | Partnerships and acquisitions in decentralized clinical trials, risk stratification, AI in clinical research, digital health, and more. Plus new products from Smart Meter, Medidata, Cmed, and Pharmasol.

    Jun 29, 2021

  • In NASH and NASH Cirrhosis, the Focus Should Be on Clinically Meaningful Endpoints

    Clinical Research News | Along with the worldwide rise of obesity comes a rise in people diagnosed with nonalcoholic Steatohepatitis (NASH), where fat stored in the liver causes inflammation, tissue damage, and eventually cirrhosis. NASH represents a major opportunity to find new treatments, as none has been approved specifically for this disease, but clinical trials for NASH treatments should focus on clinically meaningful endpoints.

    Jun 28, 2021