• The Scope of Things: Ken Getz’s Data-Driven Approach to Patient Engagement

    Clinical Research News | Ken Getz and host Deborah Borfitz explore patient engagement for the newest episode of the Scope of Things podcast. Getz, Executive Director & Research Professor at the Tufts Center for the Study of Drug Development (CSDD), shares what his research has revealed about how patient engagement efforts are progressing, where we’re stuck in a rut, and a crucial misalignment in the industry’s view of patient engagement and what clinical research participants actually want.

    May 3, 2022

  • Follow the Money: Digital Twins in Clinical Research, Virtual Care and Digital Medicine, More

    Clinical Research News | Funding for digital twin use in clinical trials, immune-oncology cancer therapeutics, and virtual care and digital medicine, and more.

    Apr 29, 2022

  • AI and ML in Clinical Trials; Risk Management Software Update; Synthetic Control Arms; Decentralized Clinical Trials; More

    Clinical Research News | AI and ML in clinical trials, patent for minimum residual tumor detection, T-cell receptor engineering for cancer treatment, award given for COVID-19 clinical trial activities, synthetic control arms and decentralized trials, and more.

    Apr 28, 2022

  • Pragmatic Trial Suggests It May Take A Village To Tap Full Potential Of Genomics

    Clinical Research News | In a pragmatic clinical trial at a pair of health systems in New York City, researchers at the Mount Sinai Health System have determined that the full potential of genomics to improve clinical patient management may well depend on engaging community-based racial and ethnic minority groups in the effort. The National Institutes of Health is now funding a large, comprehensive nationwide study (GUARDD-US) through the Implementing Genomics in Practice (IGNITE) network aimed both at changing health behaviors and making pharmacogenomics-based treatment recommendations.

    Apr 25, 2022

  • Continuous Bioprocessing of Biologics: The Future is Bright

    Clinical Research News | While most medicines are derived from chemical compound, biologics are now the fastest-growing drug class. To deliver these complex drugs to patients as quickly as possible, the biopharmaceutical industry is shifting away from traditional batch processing to continuous bioprocessing.

    Apr 22, 2022

  • CLIA-Certified Alzheimer’s Blood Test Gets High Marks In Global Study

    Clinical Research News | A blood test to help clinicians diagnose Alzheimer’s disease is “on the road” to effectively replacing cerebrospinal fluid (CSF) testing and PET scans for detecting Alzheimer’s pathology, according to Randall J. Bateman, M.D., a professor of neurology at Washington University School of Medicine and co-developer of the plasma protein assay. A commercial version of the test, PrecivityAD, is already being used extensively in clinical trials as well to evaluate patients in real-world settings.

    Apr 19, 2022

  • ‘Professional Patient’ Detection Now A Clinical Study Essential

    Clinical Research News | After more than a decade in the business of detecting “professional patients,” Verified Clinical Trials is a familiar name to stakeholders across the research enterprise—including the nefarious players who ride-share from city to city in search of unprotected sites where they can enroll in studies purely for the financial gain. It’s an underappreciated underground economy that is costing sponsor companies time and money and, in some cases, completely shutting down studies, according to Mitchell Efros, M.D. FACS, CEO of Verified Clinical Trials.

    Apr 13, 2022

  • Seqster Launches Real World Data Tools on Salesforce AppExchange

    Clinical Research News | Seqster PDM has launched SeqsterOS, the operating system for patient registries and clinical studies on Salesforce AppExchange integrated directly with Salesforce Health Cloud. SeqsterOS seeks to empower life science enterprises to seamlessly integrate patient-consented Real World Data, including electronic health records (EHR), genomics, and device data, with a patient engagement layer for their clinical studies.

    Apr 12, 2022

  • EMA Endorses Biomarkers For Type 1 Diabetes Prevention Trials

    Clinical Research News | Following many years of collaborative patient-level data sharing across stakeholder groups, the European Medicines Agency (EMA) recently endorsed pancreatic islet autoantibodies as enrichment biomarkers for type 1 diabetes (T1D) trials focused on delaying or preventing the disease. The Qualification Opinion appears on both the EMA website and that of the Critical Path Institute’s (C-Path) Type 1 Diabetes Consortium (T1DC).

    Apr 8, 2022

  • Building Clinical Trial Infrastructure for Greater Diversity

    Clinical Research News | The life sciences industry has faced recent criticism for its continued challenge to boost diversity in clinical trials. Reports suggest that the US Food and Drug Administration (FDA) is currently at work on guidance that will define how the agency would interpret “adequate representation” of ethnic, racial and age diversity to increase representation of traditionally underrepresented populations in drug development. This will ensure organizations are broadening eligibility criteria through inclusive trial practices and trial design.

    Apr 8, 2022

  • 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

  • Merck Employs Virtual Reality To Combat Burden Of Long Study Visits

    Clinical Research News | As Merck recently learned, relationships with scientific leaders and outside experts can be critical to enhancing the pediatric patient experience. That was one of the take-home messages from a case study on how the company executed on a virtual reality innovation that took first place honors during Participant Engagement Award ceremonies at the recent Summit for Clinical Ops Executives (SCOPE).

    Mar 16, 2022

  • New Pan-Cancer Prognostic Score Outperforms Existing Tools

    Clinical Research News | Roche has developed a pan-cancer prognostic scoring system useful for predicting patient survival in clinical trials and monitoring treatment progress over time. The score comprises 27 routinely collected clinical parameters and outperforms all other existing scores in every study phase, according to Anna Bauer-Mehren, data science lead for Roche Pharmaceutical Research and Early Development in Germany.

    Mar 15, 2022