Remove tag risk-assessment
article thumbnail

Grand Rounds February 23, 2024: Virtual Vigilance: Monitoring of Decentralized Clinical Trials (Adrian Hernandez, MD; Christopher J. Lindsell, PhD)

Rethinking Clinical Trials

Under RBM, the process by which study materials get to participants should be considered high risk and monitored accordingly. Baseline state, treatment, outcome, and safety data are critical to understanding treatment benefits and risks. The skills may also vary between trials and getting participants the care they need.

article thumbnail

Grand Rounds April 14, 2023: RECOVER in Action – Status of Clinical Trial Protocols (Kanecia Zimmerman, PhD, MD, MPH)

Rethinking Clinical Trials

The 5 platform protocols are integrated rather than siloed, disparate studies to achieve efficiencies, allow researchers to rapidly assess targeted therapeutics and pivot as needed to new treatment arms, maximize knowledge gained from patient participation, and to enable cross-trial analysis and accelerated knowledge acquisition.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Grand Rounds January 12, 2024: Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce Covid-19 Resources (Erin K. McCreary, PharmD, BCIDP)

Rethinking Clinical Trials

The therapeutics and ethics committees grouped immunocompromised patients into 3 risk categories, with a lottery for those patients in group 1 (highest risk). Tags #pctGR, @Collaboratory1 The post Grand Rounds January 12, 2024: Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce Covid-19 Resources (Erin K.

article thumbnail

Grand Rounds Ethics and Regulatory Series January 13, 2023: Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials (Emily A. Largent, JD, PhD, RN)

Rethinking Clinical Trials

Beneficence involves minimizing risks, and ensuring they stand in reasonable relation to potential benefits. Researchers seeking to enroll people living with dementia need a plan for assessing participants’ capacity to consent to research participation. You need to have a plan in place for assessing capacity and ability to consent.

Trials 130
article thumbnail

WHO update on Omicron

The Pharma Data

1.1.529 a variant of concern, named Omicron, on the advice of WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). Other treatments will be assessed to see if they are still as effective given the changes to parts of the virus in the Omicron variant. On 26 November 2021, WHO designated the variant B.1.1.529

article thumbnail

Grand Rounds September 8, 2023: The DEVICE Trial: An Embedded, Pragmatic Trial of Emergency Airway Management (Matthew Prekker, MD, MPH; Jonathan Casey, MD, MSc)

Rethinking Clinical Trials

Nearly 2,000 patients were assessed for eligibility and 1,417 patients were enrolled. Tags #pctGR, @Collaboratory1 The post Grand Rounds September 8, 2023: The DEVICE Trial: An Embedded, Pragmatic Trial of Emergency Airway Management (Matthew Prekker, MD, MPH; Jonathan Casey, MD, MSc) appeared first on Rethinking Clinical Trials.

Trials 141
article thumbnail

Grand Rounds May 12, 2023: Design and Pragmatic Trial of COACH: A Patient Portal/EHR Information System for Home Blood Pressure Monitoring in Hypertension (Richelle J. Koopman, MD, MS)

Rethinking Clinical Trials

Researchers assessed the effect of the data visualization on patient risk perception and the interaction of health literacy, numeracy, and graph literacy with the data visualization. Starting in 2015, researchers held 10 focus groups with patients, family medicine and general internal medicine physicians and 1 CMIO.

Trials 130