• Making the (Regulatory) Grade With Real-World Data

    Clinical Research News | How to assess the quality of real-world data (RWD) for research purposes and apply it in real-world scenarios to add efficiencies to clinical trials and support claims about drug product effectiveness were top topics of interest at the recent Summit for Clinical Ops Executives (SCOPE) in Orlando. Many providers in the fast-growing RWD landscape are focused on a specific therapeutic area, including Flatiron Health. In addition to offering an oncology-specific electronic health record (EHR), the company has partnered with the U.S. Food and Drug Administration (FDA) to find ways to integrate EHR-derived evidence into regulatory decision-making.

    Mar 12, 2020

  • Novel Digital Endpoints: Adoption Holdups Include Device Variability, Managing Change

    Clinical Research News | Novel digital endpoints, including motion-detecting sensors and electronic patient-reported outcomes, hold tremendous promise for advancing precision medicine, expanding the reach of clinical research and reducing the burden of study participation. But adoption is being slowed by the abundance of tools and measures, sponsor inexperience with the technologies, and unfamiliar risks that software introduces into trials.

    Mar 11, 2020

  • Using Real-World Data In Rare Disease Research

    Clinical Research News | Agencies around the world hold highly consistent views on the use of real-world data (RWD) to support regulatory decision-making—especially when it comes to synthetic control arms in rare disease studies. The barriers have less to do with regulators than data access, quality, and completeness and the technical skills required to harmonize, link and enrich disparate datasets, based on a pair of case study presentations made at the 11th Annual Summit for Clinical Ops Executives (SCOPE) in Orlando.

    Mar 10, 2020

  • Pfizer Embraces VR Simulations To Improve Protocol Compliance

    Clinical Research News | Pfizer has teamed up with digital training company Gronstedt Group to bring virtual reality (VR) simulations to investigative sites as a way of improving compliance with clinical trial protocols, including the way study drugs get compounded. The VR solution was demonstrated live during a recent co-presentation at the 11th Annual Summit for Clinical Ops Executives (SCOPE) in Orlando.

    Mar 9, 2020

  • Fireside Chat: How Digital Technologies Are Transforming Clinical Research

    Clinical Research News | ORLANDO—“We’re really heading toward a pathway that’s unsustainable for clinical development,” said Jacob LaPorte, co-founder, VP, and Global Head of BIOME—Novartis’ Digital Innovation Lab. “You look at ROI for R&D and every year it drops, and I think there some real macro-picture issues that are challenging. Solving this problem around clinical development is one of the biggest grand challenges for R&D now.”

    Mar 6, 2020

  • Trends in Drug Development: Improving ROI on R&D

    Clinical Research News | A surge in innovative pharmaceutical drug discovery has coincided with a decline in a return on investment (ROI) in pharmaceutical R&D. But, according to a new research report, a remedy is readily available.

    Mar 5, 2020

  • Patient Power Survey Reveals Nearly Half Of Cancer Patients Never Discuss Clinical Trials With Doctors

    Clinical Research News | The medical and pharma industries, not the patients, are the cause of low clinical trial participation, says one patient advocate. The remedy is available but requires these industries to forego rigid paradigms, to re-examine their thinking on patient participation, and to refocus their priorities.

    Mar 4, 2020

  • Artificial Intelligence Ushers in a New Era of Cost-Effective Clinical Trials

    Clinical Research News Contributed Commentary | Clinical trials have changed significantly over the past several years. As drugs and devices—and the conditions they are trying to impact—have become increasingly more complex, so has the design and structure of clinical trials. But protocols are costly to change and identifying and enrolling the right patient cohorts is also no easy feat—especially when rare diseases are the target. Study teams are using artificial intelligence (AI) and machine learning (ML) to keep up with this rapid pace of change.

    Mar 3, 2020