• 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

  • AI-Generated Treatment Planning Algorithm Meets Real-World Medicine

    Clinical Reaserch News | One of the world’s largest cancer centers is believed to be the first to deploy artificial intelligence (AI) in a therapeutic capacity on real-world patients—specifically, for curative-intent radiation therapy treatment planning for prostate cancer. The methodology involves training an AI machine learning algorithm on previously treated patients to generate radiation treatments for new patients.

    Jun 24, 2021

  • Digital Patients Could Help More Drugs Reach Market

    Clinical Research News | Clinical trials employing digital representations of patients and running in parallel with actual clinical trials could soon help researchers understand what separates responders and nonresponders to a drug.

    Jun 23, 2021

  • How Duplicate Subjects in Clinical Trials Can Cripple Research Efforts

    Clinical Research News | There are many obstacles to successful and reliable clinical trials, however one challenge is often ignored: duplicate subjects in clinical trials. These individuals go by many names: “professional patients”, “professional study subjects”, and “duplicate subjects”. Their involvement and unscrupulous behavior greatly threaten the integrity of clinical trials.

    Jun 22, 2021

  • Digital Medication Adherence enables Data-Guided Feedback and Patient-Centered Clinical Trials

    Clinical Research News | While medication adherence has long been a measure of engagement with treatment in the healthcare setting, the metric has not, so far, been translated into the sphere of clinical research. It is time to embrace the combined power of digital health, smart devices and packaging, and data science to finally understand medication adherence, and use that knowledge to support participation in clinical trials.

    Jun 17, 2021

  • Gamifying Vision: How Mobile Gaming Is Tracking Vision Degradation in Patients

    Clinical Research News | Tilak Healthcare aims to combine video games with medical expertise so that the same vision monitoring tools that are reliable and useful for doctors will be playful and fun for users. If Tilak can achieve that, the company tools will be “sticky” enough to have a longstanding impact on the healthcare process for patients.

    Jun 16, 2021