• Adverse Event Reporting May Need A Total Redo

    Oct 20 | Clinical Research News | The reporting of adverse events (AEs) in randomized controlled trials (RCTs) has only modestly improved over the past two decades. But more consistent inclusion of AEs in published studies will not, by itself, provide a balanced picture of the potential harms of interventions. More
  • Global Consensus Building On Core Outcome Set For ‘Long COVID’ Studies

    Oct 19 | Clinical Research News | By the end of this year, consensus by a global coalition of researchers, healthcare providers, and patients on a core set of outcomes that should be included in all future studies of post-COVID syndrome—so-called “long COVID”—are expected to be publicly released. A core outcome set (COS) is urgently needed to optimize and standardize clinical data collection and reporting across clinical trials for the condition. More
  • How Decentralized Trials Make Research More Accessible and Inclusive for Participants and Sites

    Oct 15 | Clinical Research News | Traditionally designed clinical trials chronically struggle to enroll representative patient populations that will yield the comprehensive data needed to ensure that a new treatment will be safe and effective for everyone. I’ve been excited to watch decentralized clinical trial (DCT) approaches become more widely adopted because of their potential to democratize access to research. In order to produce the most accurate and reliable data about each new drug’s efficacy and safety, we have to meet participants and under-resourced sites where they are. More
  • How Pfizer Used Intelligent Machines to Take on Clinical Data

    Oct 12 | Clinical Research News | Data determines AI feasibility, explained Prasanna Rao, Head of AI and Data Science at Pfizer. Formerly of IBM Watson, Rao outlined Pfizer’s recent experience implementing AI tools to aid with clinical data management at last month’s Bio-IT World Conference & Expo. More
  • Follow the Money: Virtual Care, Diversity in Trials, Personalized Medicine Plans

    Oct 11 | Clinical Research News | Investments in virtual care, clinical trials for children and pregnant women, incentivizing diverse researchers to use the All of Us dataset, and more. More
  • Decentralized Trials & Research Alliance Grows, Partnerships in Site Conduct, Trial Diversity, More

    Oct 07 | Clinical Research News | Decentralized trials around the world; partnerships with Eli Lilly, Great Ormond Street Hospital for Children, UNC Chapel Hill, Bristol Myers Squibb; and mergers and acquisitions. Plus: new products from Sensyne Health, Egnyte, and more. More
  • Experts Say Surrogate Endpoints Need More Regulatory Oversight

    Oct 04 | Clinical Research News | “The benefits of using surrogate endpoints in drug trials are often outweighed by the harms of not knowing in a timely manner whether a new drug is effective in improving patient-relevant outcomes,” according to Huseyin Naci, associate professor of health policy at the London School of Economics and Political Science. Drugs approved based on surrogate endpoints—indirect measures for predicting outcomes such as laboratory values and radiographic images or, in oncology, response rates and disease-free survival—are sometimes later found to be ineffective or harmful. More
  • The Case For Considering Sex And Gender In Clinical Studies

    Sep 27 | Clinical Research News | Researchers in Europe have found that most COVID-19 clinical trials to date have paid scant attention to the impact of sex and gender on the efficacy of pharmacological interventions—even after it became clear that those variables could have a striking effect on the outcomes of infected individuals. The findings could help make the case for “more and clearer regulations” around sex- and gender-sensitive analysis of study results. More
  • Clinical Trial Trends: 18 Months of Faster Tech Adoption, Real World Data, Increased Collaboration

    Sep 22 | Clinical Research News | Namita Limaye, Research VP at IDC, gave a broad overview of IDC’s survey findings over the past 18 months at this week’s Bio-IT World Conference and Expo held in Boston and online. She highlighted trends in the life sciences and clinical trials industries that included increased collaboration, speedier adoption of technologies, reliance on real world data, and more. More
  • Machine Learning Adds Speed To Electronic Health Records-Based Phenotyping

    Sep 21 | Clinical Research News | In clinical informatics research, creation of rule-based algorithms is a robust method for mining electronic health records (EHRs) to classify diagnoses. But the process requires considerable time and expertise to build, refine, and deploy, which explains why to date only 81 phenotypes have a publicly available algorithm. More
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