• An Application Now Rests with the FDA: How to Manage the Review Process

    Clinical Research News | What is happening inside the FDA and the Center for Drug Evaluation and Research (CDER) statisticians in the review of the drug/device application? We look at what data are analyzed, the integrated review process, and labeling and post-approval evaluation.

    Aug 13, 2021

  • Ovarian Cancer Chip Model Reveals Drug Repurposing Opportunities

    Clinical Research News | A novel organ-on-a-chip model of ovarian cancer has been used to showcase the sinister activities of tumors, including use of circulating platelets to fuel their growth and undermine treatment with chemotherapeutic drugs. The model also demonstrated the potential of an anti-platelet drug, currently in clinical trials for a different condition: to fight back.

    Aug 11, 2021

  • What You Don’t know, Will Hurt You: Overcoming “Missingness” in Healthcare Data

    Clinical Research News | Most data sets—especially in healthcare—are missing data and, therefore, may not sufficiently representative to support the broader conclusions being drawn about groups of patients. Missing values is a problem that data scientists refer to as “missingness.” Even if data isn’t specifically missing, often the quality of the data is so poor that it is unusable and functionally considered missing. This missingness often leads directly to poor analytics outcomes.

    Aug 6, 2021

  • Follow the Money: Clinical Trial Platforms, Improving Diversity in Trials

    Clinical Research News | Novartis and PCORI both invest in eliminating racial disparity in clinical research, 4G gets a big growth equity investment for randomization and trial supply management, ObvioHealth seeks to integrate the EHR for clinical trial design, and more.

    Aug 5, 2021

  • Parexel Acquisition, Medable Expands to Europe, NSF Funds for RWE Outcomes

    Clinical Research News | Parexel acquired by private equity business, American Heart Association seeks genomic diversity, partnerships for Flywheel and HealthMyne as well as Marken and THREAD.

    Aug 3, 2021

  • Patient-Centric Focus, Awareness, Technology Can Fix Pharma’s Lack of Progress on Trial Diversity

    Clinical Research News | Conversations of diversity in clinical trials has been just talk for a long time. It’s great that study results are being reported with demographic data about race and ethnicity, but it’s still up to the individual pharma company whether it wants to report diversity or not. This is not the path toward meaningful change.

    Jul 30, 2021

  • Machine Learning Can Predict If COVID-19 Trials Will Succeed

    Clinical Research News | A pair of computer scientists at Florida Atlantic University have come up with a machine learning approach to predict the likelihood of a clinical trial being terminated down the road and attribute factors contributing to study termination or success. When applied to the flurry of COVID-19 trials launched since early last year it performs particularly well.

    Jul 29, 2021

  • Data Privacy And Patient-Centeredness Driving Technology Adoption

    Clinical Research News | The potential of artificial intelligence (AI), internet-connected devices, wearables, and cloud computing to disrupt traditional clinical trials was explored during a presentation on patient-centered endpoints at the recent DIA 2021 Global Annual Meeting. The common goal is to make studies more palatable for participants, improving their engagement and retention, and to help pick up the pace and cost of making new medicines.

    Jul 26, 2021

  • 5 Reasons Why a Decentralized Method Works for Clinical Trials

    Clinical Research News | With sponsors like IQVIA, Pfizer, and GSK joining the Decentralized Trials & Research Alliance and the FDA giving decentralization its nod of approval, it’s safe to say the clinical research industry will continue to embrace decentralized trials.

    Jul 23, 2021

  • Building Trust In Real-World Evidence

    Clinical Research News | Lessons learned to date about the growing use of real-world evidence (RWE), including emerging approaches to improve study design and the measurement of treatment effects, were highlighted during a presentation by regulatory and pharmacoepidemiology (PE) experts at the recent DIA 2021 Global Annual Meeting. The wide-ranging conversation touched on everything from the regulatory context in which RWE is being used and whether clinical questions can be reliably addressed to the quality of real-world data (RWD) sources and more rigorous methodological approaches that might be adopted to help ensure confidence in study findings.

    Jul 21, 2021

  • Overcoming Barriers To Using Artificial Intelligence In Clinical Research

    Clinical Research News | Current and potential uses of artificial intelligence (AI) and automation in clinical research, and ways to overcome common barriers, were discussed by a panel of industry experts at the recent DIA 2021 Global Annual Meeting. Two multi-stakeholder communities of practice groups now meet regularly to explore ways to leverage AI and machine learning (ML), one focused on improving trial quality and cycle times and the other producing high-quality protocols and reducing risks before the start of a study.

    Jul 20, 2021

  • MedVector To Connect Patients Of Local Physicians To Study Investigators

    Clinical Research News | A startup is positioning itself to be a key player in the burgeoning decentralized clinical trial (DCT) marketplace and has tapped industry innovator Craig Lipset, who designed and co-led the industry’s first fully virtual clinical trial, to be its executive advisor. MedVector is the first company to enable local, non-investigative physicians to access clinical trial medications as a care alternative.

    Jul 19, 2021

  • The Ultimate Patient-Centric Supply Chain

    Clinical Research News | A supply chain strategy that truly puts patients at the center requires a wide variety of trial services, delivered seamlessly. Improved patient access, reliability, customizability—all these things are incompatible with fragmented service and require the central coordination and end-to-end oversight only available from a comprehensive, single-source solutions provider.

    Jul 16, 2021

  • Studies Using External Control Arms Gaining Ground

    Clinical Research News | The willingness of healthcare authorities to accept external control arms (ECAs) in regulatory submissions depends largely on how and when they are used, according to real-world data (RWD) experts from Merck, Bristol-Myers Squibb, and Ikaika Health who presented at the recent DIA 2021 Global Annual Meeting.

    Jul 16, 2021

  • 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