• How To Integrate The Patient Voice Into Trial Design

    Clinical Research News | The need to listen to the voice of patients at the right time, in the right context, and in their own language was a dominant theme of a live panel session at the recent Summit for Clinical Ops Executives (SCOPE) where views were shared on integrating patient insights into clinical trial design.

    Mar 15, 2021

  • Clinical Control Tower Providing Near-Real-Time View Of GSK Trials

    Clinical Research News | Thanks to COVID-19, asset leads at GlaxoSmithKline (GSK) can now tap a Clinical Control Tower for answers to five critical questions about how studies are progressing and if they are veering off course. The platform was developed last year to enable trial leaders to maintain business continuity during the pandemic.

    Mar 12, 2021

  • Antibodies Plus Vaccines, RWD on Post-Shot Reactions: COVID-19 Updates

    Clinical Research News | Top COVID-19 news and research stories of the week: real-world data from Mass General Brigham staff after vaccination, antibodies and the jab, and springtime impacts on infection rates.

    Mar 12, 2021

  • SCOPE 2021 Highlights New Value Props From Vendors

    Clinical Research News | New products, acquisitions, and a Cannes Film Festival award—some of the noteworthy announcements heard on the virtual exhibit hall floor during SCOPE 2021.

    Mar 11, 2021

  • Janssen Lost Little Ground on Trials Due To COVID-19

    Clinical Research News | Many of the process-related changes Janssen made in response to COVID-19—including virtual investigator meetings, analytic risk-based monitoring (ARBM), and direct-to-participant clinical trial approaches—will endure beyond the pandemic.

    Mar 10, 2021

  • Solving Real Problems from the Depths of the Technology Echo Chamber

    Clinical Research News | Much is said about how technology can transform healthcare with countless technologies being explored and used like machine learning, IoT, wearables, biosensors, natural-language processing, and digital therapeutics. But before we chase the latest and greatest technology, we must ask the critical question: “What problem are we trying to solve?”

    Mar 9, 2021

  • How Pfizer’s ‘Science Will Win’ Mantra Played Out Behind The Scenes

    Clinical Research News | One year after COVID-19 was declared a pandemic by the World Health Organization, a handful of Pfizer clinical operations leaders talked openly about the “one-team mindset” that helped usher a safe and highly efficacious vaccine to market in record time.

    Mar 8, 2021

  • Data-as-a-Service for Trials, Real World Data, Genomics Data For Cancer Trials: News and Products for February

    Clinical Research News | Wearables for blood cancer clinical trials, new members of DTRA, new light and health research center, digital twin consortium, and more.

    Mar 8, 2021

  • Oral Disorders Linked to SARS-CoV-2, Statin Use Increases Survival Rate, Abnormal Sodium Levels Predict Death Risk: COVID-19 Updates

    Clinical Research News I Repurposed arthritis drug falls short in Phase 3 clinical trial, optimal timing for donating convalescent plasma is within 60 days of symptom onset, most pregnant women and mothers report that they will vaccinate themselves and children, and only small percentage of COVID-19 patients suffer stroke, risk increases with age and CV risk factors. Plus: Clinicians warn of delayed injection-site reaction to Moderna vaccine for proper management and swollen salivary glands may be a common COVID-19 side effect.

    Mar 5, 2021

  • SCOPE 2021: New Players in Clinical Trials, AstraZeneca on RWE, Transcelerate Updates

    Clinical Research News | Day two of the Summit for Clinical Ops Executives (SCOPE) brings more updates from big pharma on the impacts of the COVID-19 pandemic, how AstraZeneca in deploying real-world evidence (RWE) in trials across broad therapeutic areas, and more.

    Mar 4, 2021

  • Medidata Named Winner of 2021 Participant Engagement Award

    Clinical Research News | Live at SCOPE yesterday, the winner of the 2021 Participant Engagement Award was chosen by a panel of judges. Patient Centricity by Design, a project from Medidata, was named the grand prize winner.

    Mar 3, 2021

  • SCOPE 2021: Pfizer, GSK’s Approach to COVID-19 Research, Patient Voice In Trials

    Clinical Research News | At the kickoff day for the Summit for Clinical Ops Executives 2021, teams from Pfizer talk vaccine development, Bayer, Pfizer, Abbvie and GSK report on the role of the patient in trial development, and GSK discusses the need for a “single source of truth” in pandemic response.

    Mar 3, 2021

  • Pandemic Highlights Value Of Remote Clinical Trials, Drug Repurposing

    Clinical Research News | A keynote address earlier this morning during opening ceremonies of the 2021 Summit for Clinical Ops Executives (SCOPE) offers glimmers of hope that the notoriously rigid clinical trial process may retain at least a few of the warp-speed changes introduced by the COVID-19 pandemic.

    Mar 2, 2021

  • Intranasal Vaccines, Vax Data for RWD Exploration, Down Syndrome Impacts: COVID-19 Updates

    Clinical Research News | A survey of how rehabilitation is helping patients with severe COVID-19, what COVID-19 means for Down Syndrome patients, and the timing of vaccines. Plus: real world data for COVID-19 vaccination, intranasal COVID-19 vaccine, more.

    Feb 26, 2021

  • It Took A Village To Speed Pfizer COVID-19 Vaccine Into Arms

    Clinical Research News | Deployment of clinical trials for Pfizer’s COVID-19 vaccine candidate was the fastest in the company’s history, and possibly industry-wide. Six weeks after the decision was made to run the combined phase 1/2/3 study, the first patient was enrolled and, six months later, it had all the safety and efficacy data needed to request Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to start getting the vaccine into people’s arms.

    Feb 25, 2021

  • Adaptive Trial Design Takes Center Stage During Pandemic

    Clinical Research News | The pandemic has had some “silver linings” for clinical studies and the overall U.S. healthcare system, according to speakers discussing adaptive trial design at the recent COVID-19 and Cancer virtual meeting of the American Association for Cancer Research (AACR). We can’t go back to business as usual.

    Feb 23, 2021

  • PTSD, Lasting Heart Damage, Brain Findings: Lasting Impacts for COVID-19 Patients

    Clinical Research News | Europe’s vaccination priority for the mentally ill, fighting “vaccine nationalism”, how the humidity inside the face mask can help. Plus: trials of remdesivir in pregnant women, EMA releases guidance on trials during pandemic, and seeking priority vaccines for cancer patients, diabetes sufferers.

    Feb 19, 2021

  • GSK’s Protocol Design Lab Offers Actionable Insights To Study Teams

    Clinical Research News | A Protocol Design Lab (PDL) launched by GlaxoSmithKline (GSK) at the end of 2019 is endeavoring to harness insights from real-world data, clinical trials, and patients themselves to create “operationally viable” protocols linked to predetermined value drivers—notably, clinical studies that are faster and less costly to conduct and include a greater diversity of patients.

    Feb 18, 2021

  • 2021 Participant Engagement Award Finalists Announced

    Clinical Research News | Finalists have been named for the 2021 Participant Engagement Award, the industry’s premier effort to highlight creative work in clinical research that helps better engage and understand research participants. Winners will be announced the first week of March at SCOPE, the Summit for Clinical Ops Executives.

    Feb 17, 2021

  • With a Pandemic Push, DCTs Are a ‘Virtual’ Lock to Go Big in ‘21

    Clinical Research News | One of the bright spots in 2020 is the growth of Decentralized Clinical Trials (DCTs). DCTs are virtual trials that integrate remote assessments with modern digital health technologies, including remote rating apps, wearable monitoring devices, and online social engagement platforms into study design and execution. They were already growing in popularity prior to COVID-19, thanks to regulatory acceptance, trends in clinical practice and the operational/cost efficiencies, but the ongoing global pandemic has accelerated the implementation of DCTs, bringing us to a tipping point.

    Feb 17, 2021