• Follow the Money: 3D Telepresense, Transplant Rejection Trials

    Clinical Research News | Clinical trials for lung transplant rejection and sickle cell disease, immersive 3D telepresense for remote patient engagement, and precision dosing technology.

    Dec 2, 2021

  • Engaging Risk-Based Quality Monitoring Teams Through Role-Playing

    Clinical Research News | Most pharmaceutical companies today have a dedicated team for risk-based quality management (RBQM) whose job it is to imagine the many ways clinical trials could go wrong to prevent their failure. Gone are the days when averting risk was largely an exercise in source data verification based on the perceived difficulty in study execution, says Marcin Makowski, M.D., Ph.D., head of centralized monitoring and data analytics at GlaxoSmithKline (GSK).

    Dec 1, 2021

  • Roche Announces IMPACT Trial Results, RWE Acquisitions, More

    Clinical Research News | Acquisitions for THREAD, Elsevier, and Global Healthcare Opportunities. Partnerships for international trials and AI-based clinical trial acceleration software. Plus new products from Intuity Medical, Florence, uMotif, and more.

    Nov 30, 2021

  • (Clinical) Trial or Error: The Modernization of Respiratory Clinical Trials

    Clinical Research News | Historically, clinical trials are slow and costly, and of all therapeutic areas, none is more expensive than respiratory trials. How can the pulmonary field that is still struggling to cope with COVID-19, massive wildfires, and the epidemic of lung injury due to vaping, meet the critical need for accelerated drug development and improved clinical care? The answer must come directly from investigators and clinicians doing the work, applying technology in new ways based on what they’ve learned.

    Nov 23, 2021

  • Simplifying CDISC Compliance With Cloud-Based Clinical Metadata Repositories

    Clinical Research News | Although CDISC standards are clearly helping to expedite the review of submissions, many organizations are completing this compliance step at the end of a clinical trial. The data rework involved in this process requires significant time and resources, particularly as metadata is often held in disparate systems and the evolving standards tend to be implemented manually. Clinical metadata repositories (CMDRs) can be used to embed CDISC standards into the study’s design, build and submission.

    Nov 19, 2021

  • Gut Microbiome Linked To Aggressive Prostate Cancer

    Clinical Research News | Evidence has been mounting for decades that what men eat can lower or raise their risk of prostate cancer—including aggressive forms of the disease that can be lethal. But that’s only part of the story.

    Nov 18, 2021

  • COVID Vaccine Trials Offer Lessons For Improving Clinical Trial Diversity

    Clinical Research News | Concerted effort was required to ensure equitable inclusion of Black, Indigenous, and People Of Color (BIPOC) communities in COVID-19 vaccine trials—a complete reversal relative to historic norms. It would have been an impossibility without temporarily slowing or halting enrollment of White individuals so that the demographic composition at final enrollment closely mirrored the larger U.S. population.

    Nov 16, 2021

  • On The Tragic Passing Of Medidata’s Glen de Vries

    Clinical Research News | All of us at Cambridge Healthtech Institute, including the staff of Clinical Research News and the SCOPE conference team, are deeply saddened by last week’s tragic passing of Medidata co-founder Glen de Vries in a small plane crash in New Jersey. Encounters with the clinical trial visionary were always a privilege both for the learning opportunity and because of his especially friendly demeanor.

    Nov 15, 2021

  • Advances In Precision Medicine And Artificial Intelligence Are Set To Transform Cancer Treatment

    Clinical Research News | It’s time for healthcare organizations to open clinical trial options to patients at the beginning of the patient journey, not the terminus.

    Nov 12, 2021

  • What’s Behind Growing Adoption Of Cell-Based Vaccine Platforms

    Clinical Research News | Cell-based vaccines, initially developed to add speed and scale to pandemic response efforts and reduce dependency on chickens in the vaccine manufacturing process, have over the past few years also shown to be more reliably effective than traditional, egg-based products.

    Nov 10, 2021

  • ERT, Bioclinica Rebrand As Clario

    Clinical Research News | ERT today announced that following its early Q2 merger with Bioclinica, the combined company is renamed Clario.

    Nov 3, 2021

  • Follow the Money: Decentralized Trials, Security, COVID Research

    Clinical Research News | Medable’s big Series D, cryptographic data privacy, lung research, collaborative research and more.

    Nov 2, 2021

  • Science 37 Announces Two Partnerships in Japan, Veeva Launches Digital Trials Platform, More

    Clinical Research News | THREAD expands to Europe, Middle East and Africa, TD2 adopts Medidata’s Rave CTMS, Genesis Research enhances its healthcare literature research platform, and RealTime Software improves digital signatures. Plus new products from Trialbee, Vivacare, AliveCor, and more.

    Oct 29, 2021

  • Bringing The Fight To Antimicrobial Resistance: What COVID-19 Has Taught Us About How To Face A Growing Emergency

    Clinical Research News | Even as we make large strides toward the end of the pandemic, there is another growing global health crisis: antimicrobial resistance (AMR). The World Health Organization (WHO) calls AMR one of the top ten public health threats. There is an urgent need to focus on combating the health threat of AMR. The COVID-19 crisis, and the ensuing race to find treatments, has offered innovative and insightful approaches to implementing successful clinical trials related to infectious disease.

    Oct 27, 2021

  • Data-Sharing Platform Aims To Speed Drug Development For Rare Diseases

    Clinical Research News | The Critical Path Institute (C-Path) recently debuted a first-of-its-kind Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) to encourage data-sharing and collaboration among investigators to accelerate treatment innovation for rare diseases. The ultimate value of the platform will be in getting drugs approved quicker.

    Oct 25, 2021

  • Adverse Event Reporting May Need A Total Redo

    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.

    Oct 20, 2021

  • Global Consensus Building On Core Outcome Set For ‘Long COVID’ Studies

    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.

    Oct 19, 2021

  • How Decentralized Trials Make Research More Accessible and Inclusive for Participants and Sites

    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.

    Oct 15, 2021

  • How Pfizer Used Intelligent Machines to Take on Clinical Data

    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.

    Oct 12, 2021