• 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
  • The FDA’s Playbook For Accelerating COVID-19 Vaccine Development

    Clinical Research News | At the recent COVID-19 and Cancer virtual meeting of the American Association for Cancer Research, the role of the U.S. Food and Drug Administration (FDA) in expediting the development and deployment of a vaccine was the topic of a keynote address by Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). His talk focused heavily on a pair of guidance documents issued by the agency last year, including one in October specific to requests for Emergency Use Authorization (EUA) for COVID-19 vaccines.

    Feb 16, 2021