• Clinical Data Sharing for AI: Proposed Framework Could Rouse Debate

    Clinical Research News | A group of doctors from Stanford University has proposed a framework for sharing clinical data for artificial intelligence (AI) that could set off a firestorm of debate about who truly owns medical data, ethical obligations to share it, and how to properly police researchers who use it. On the other hand, the envisioned approach has parallels to the open science tactics currently being uniformly deployed to battle the COVID-19 pandemic.

    Mar 24, 2020

  • New Paths Ahead for Circadian Medicine

    Clinical Research News | A growing body of evidence suggests there are multiple health benefits to working with, rather than against, the body’s natural circadian rhythms—starting with when we eat, sleep, and take our medicines. Basic science research and observational studies have long dominated the literature, but more interventional trials are now getting underway aimed at correcting disturbances in biological timing triggered by disease, advancing age, and always-on modern lifestyles, as well as optimizing outcomes based on treatment timing.

    Mar 23, 2020

  • Three Ways Clinical Trials Will Be Enhanced In 2020

    Clinical Research News Contributed Commentary | New methods for collecting, analyzing, and sharing clinical trial data are needed in the era of personalized medicine. Beginning this year, we’ll see new trial designs being introduced that recognize a larger, broader section of the patient population.

    Mar 18, 2020

  • 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

  • Proven Tactics For Recruiting and Retaining Patients in Studies

    Clinical Research News | Study sponsors looking to improve recruitment and retention in clinical studies—particularly for rare disease research where patients are in scarce supply—might want to apply some of the proven tactics recently shared by Signant Health and UBC at the 11th Annual Summit for Clinical Ops Executives (SCOPE) in Orlando.

    Mar 2, 2020

  • Tips For Improving Patient Engagement and Clinical Trial Experiences

    Clinical Research News | As part of its ongoing efforts to build a patient-centric culture, Takeda is taking patient engagement in drug development to a whole new level, according to Jessica Scott, M.D., JD, head of R&D patient engagement. “Patients want to be part of the process and share the experience with us,” she said from the stage at the 11th Annual Summit for Clinical Ops Executives (SCOPE) last week in Orlando.

    Feb 28, 2020

  • Reporter’s Notebook: Speakers Stress 'Patient-Centricity' During SCOPE 2020

    Clinical Research News | Members of the clinical trial and research community recently convened in Orlando, Fla, for the 11th annual Summit for Clinical Ops Executives (SCOPE). For four days, pharmaceutical companies, trial sponsors, healthcare organizations, and patient advocacy groups discussed the latest advances and innovative solutions in all aspects of clinical trial planning, management, and operation. Here are some of the bits and pieces we collected during the summit.

    Feb 27, 2020

  • ICER, TrialScope, ClinOne, And More: News From February 2020

    Clinical Research News | February was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from ICER, TrialScope, ClinOne, and more.

    Feb 27, 2020

  • Merck’s Perspective On Why Health Literacy Matters

    Clinical Research News | At Merck, the job of ensuring patient information about medicines and diseases is easy to understand falls to the one-person team of Global Health Literacy Director Laurie Myers, MBA, and she’s adamant that best practices in the field need to be shared. “Patients have the right to understand information to make informed and empowered decisions,” she said during her plenary keynote at the 11th Annual Summit for Clinical Ops Executives (SCOPE) last week in Orlando.

    Feb 26, 2020

  • Effective Risk Management When Using eCOA and ePRO

    Clinical Research News Contributed Commentary | The use of direct source data capture in clinical research is on the rise, both during clinic visits and remotely by patients. This includes investigator-led and patient self-assessments using laptops or tablet devices, patient diary information using hand-held mobile devices, and wearable sensors that automatically record and transmit various health-related measurements (glucose levels, heart rate, etc.).

    Feb 25, 2020

  • Clinical Research As A Scientific Discipline: Birthing A Movement

    Clinical Research News |ORLANDO—A day ahead of the 2020 Summit for Clinical Ops Executives (SCOPE), stakeholders from across the clinical trials enterprise convened for a campfire-style chat on ways to elevate the status of clinical research as a scientific discipline and foster collaboration and pre-competitive knowledge sharing to improve trial conduct. The SCOPE Scientific Symposium (SSS) was led by a half dozen leaders from AbbVie, Pfizer, Biogen, Boston Millennia Partners (BMP), and the Tufts Center for the Study of Drug Development (CSDD), with more than 50 others actively engaged in the dialogue.

    Feb 20, 2020

  • TrialScout Receives Top Honor At SCOPE’s Participant Engagement Awards

    Clinical Research News | TrialScout receives the 2020 Participant Engagement Award for its #FindtheFive campaign, a social media campaign that uses TrialScout’s platform to harness the input from the over five million Americans that have participated in some form of clinical research over the past ten years.

    Feb 19, 2020

  • IBM Watson Health Launches Study Design and Authoring Tool

    Clinical Research News| ORLANDO--IBM Watson Health today unveiled its newest cloud-based technology, IBM Study Advance, at the 11th Annual Summit for Clinical Ops Executives (SCOPE) in Orlando, Florida. The data-driven study design and authoring tool optimizes clinical trial protocol design by merging automated access to real-world patient population data, standardizing protocol template guidance and providing a collaborative workspace designed to facilitate efficiency.

    Feb 18, 2020