• Matching Japan’s Real-World Databases To Research Purposes

    Clinical Research News | Japan has a variety of databases available to researchers, but knowledge and experience is needed to understand the characteristics of each one and select wisely, according to two representatives of CMIC Group, the country’s largest contract research organization. The database options are tied to Japan’s publicly funded healthcare system that provides universal health insurance and the freedom to choose among medical institutions offering consistently high-quality, low-cost medical care.

    Apr 7, 2022

  • The Scope of Things: Craig Lipset on Decentralized Trials, the New Risk Model, and Open Doors

    Clinical Research News | The pandemic has certainly been a turning point for decentralized trials, and Craig Lipset, co-chair of the Decentralized Trials and Research Alliance (DTRA) says the reasons are clear: the industry’s understanding of risk.

    Apr 5, 2022

  • Follow the Money: Clinical Effectiveness Studies in Urinary Incontinence, Sickle Cell Disease, Mental Health

    Clinical Research News | Funding of clinical effectiveness studies related to urinary incontinence, sickle cell disease, mental health, and hypertension management, a new gene therapy for atrial fibrillation, and funding for cloud-based clinical data analytics.

    Mar 31, 2022

  • Orphan Drug Designation for ALS Treatment, Virtual Assistants in Genetic Counseling, Clinical Research Expansion in Asia

    Clinical Research News | New orphan drug designation for ALS treatment, virtual assistants in genetic counseling, AI in healthcare professional engagement, AI-powered pathology for clinical diagnostics, clinical research expansion in Asia, more.

    Mar 30, 2022

  • The Case For Tokenizing Data On Clinical Trial Participants

    Clinical Research News | Based on a lively panel discussion at the recent Summit for Clinical Ops Executives (SCOPE), it appears enthusiasm is building for the “tokenization” of clinical research participants to link information from trials to real-world data (RWD) on the same patients. The rationale includes the ability to track individuals more easily over the long haul and contextualize adverse events detected in studies, says Tim Riely, vice president of clinical data analytics at IQVIA.

    Mar 29, 2022

  • Decentralized Clinical Trials: A Revolution Improving Safety, Efficacy, and Speed

    Clinical Research News | Decentralized clinical trials (DCTs) are an exciting and fast-growing market showing no signs of slowing down. However, the shift to DCTs can present new challenges. Examples of this include ensuring patient safety throughout clinical trials and safeguarding the quality of data produced by patients.

    Mar 25, 2022

  • Consensus Definition Of ‘Treatment-Resistant Depression’ For Regulatory Trials

    Clinical Research News | Hundreds of clinical trials are underway testing therapies for treatment-resistant depression (TRD), yet until very recently there was not a clear definition of what is even being treated. But with newly proposed criteria to describe the condition, researchers and regulatory agencies have a basis for agreement that could help inform study design and potentially improve the lives of millions of people worldwide.

    Mar 23, 2022

  • Addressing the Importance of Biospecimen Collection Protocols and Quality Control Processes for Downstream Analysis

    Clinical Research News | Following a standard protocol when collecting biospecimens and conducting a quality review to confirm that you are working on appropriate samples are critically important processes for downstream analysis in medical research. If biospecimens are not collected and processed in the same way, subject to the same quality controls, diagnosis verification, and clinical data collection, researchers will not be able to determine whether data outliers are due to disease progression or process inconsistencies.

    Mar 18, 2022