Clinical Research Informer

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

Rethinking Clinical Trials

FEBRUARY 28, 2024

The global decentralized clinical trial market is expected to grow at a compound annual growth rate of 30.1% There is agreement that trials need to meet the people, at home and covering clinical trial deserts. Regardless of the trial inclusion and exclusion is routine. from 2021 to 2026.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Grand Rounds March 3, 2023: Adoption, Implementation and Sustainment of Family-focused Prevention in Health Care Systems: How Do We Get There? (Margaret Kuklinski, PhD; Stacy Sterling, DrPH, MSW)

Rethinking Clinical Trials

JULY 14, 2023

Tyson School of Medicine Slides Keywords Pragmatic Clinical Trial, GGC4H, Prevention Key Points Guiding Good Choices for Health Study (GGC4H) is about the Guiding Good Choices (GGC) intervention, a group-based program for parents and caregivers of younger adolescents (ages 9-14). 2) Can virtual GGC be delivered with fidelity?

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Grand Rounds July 7, 2023: Implementing Virtual Strategies Across an Integrated Healthcare System: The IMPLEMENT-HF Study (Ankeet S. Bhatt, MD, MBA, ScM)

Rethinking Clinical Trials

JULY 13, 2023

There were substantial improvements in the intervention group of the pilot study and improved guideline medical therapy that indicated that the virtual nudge strategy might be beneficial and scalable to multiple entities within an integrated healthcare system. Bhatt, MD, MBA, ScM) appeared first on Rethinking Clinical Trials.

Clinical Trials

Clinical Trials Clinical Trials Scientist Research

Grand Rounds October 28, 2022: The HERO (Healthcare Worker Exposure Response & Outcomes) Program: An Online Community to Support Observational Studies, Randomized Trials, and Long-Term Safety Surveillance (Emily O’Brien, PhD, FAHA; Russell Rothman, MD, MPP)

Rethinking Clinical Trials

NOVEMBER 1, 2022

The HERO Registry aimed to create a diverse virtual community of healthcare workers and their families and communities, ready for future COVID-19 research. The first trial undertaken by the HERO Program, HERO-HCQ, evaluated the efficacy of hydroxychloroquine (HCQ) to prevent COVID-19 in healthcare workers. pctGR, @Collaboratory1.

Trials

Trials Clinical Research Vaccination Vaccine

Grand Rounds August 19, 2022: Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change (Gerald Bloomfield, MD, MPH; Michelle Kelsey, MD)

Rethinking Clinical Trials

AUGUST 23, 2022

There is a national priority to increase diversity in clinical trials, from regulatory, funding agencies, industry, and others, so that the participant population reflects the U.S. The Duke Clinical Research Institute (DCRI) organized and sponsored a Think Tank to address diversity in clinical trial research. Learn more.

Clinical Trials

Clinical Trials Clinical Trials Trials Medicine

Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH)

Rethinking Clinical Trials

AUGUST 28, 2023

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. Time, cost and failure to recruit trial participants are significant barriers that must be addressed.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH; Adrian F. Hernandez, MD, MHS)

Rethinking Clinical Trials

AUGUST 28, 2023

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. Time, cost and failure to recruit trial participants are significant barriers that must be addressed.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

Medicare savings won’t make a dent in healthcare costs

World of DTC Marketing

SEPTEMBER 9, 2021

New technologies are being developed that allow for virtual clinical trials and other cost-lowering development costs. A study put a price tag on American’s bad eating habits: $50 billion a year in health care costs, attributable to cardiometabolic diseases such as heart disease, stroke, and type 2 diabetes.

Drugs

Drugs Pharmacy Clinical Trials Clinical Trials

AI-Powered Precision Engagement in Commercial and Medical Functions

Intouch Solutions

APRIL 11, 2024

Clinical : Optimized efficiency, inventory management, and service quality of clinical trials. Offering the physician support from a virtual assistant during the differential diagnosis process where they have access to a more extensive knowledge and experience base. Manufacturing : Improved operations, efficiency, and production costs.

Compliance

Compliance Marketing Drugs Pharma Companies

Gene Silencing Porphyria Treatment, Givlaari, Finally Wins Over England’s NICE Amid Stellar Long-Term Data

XTalks

OCTOBER 26, 2021

The Phase III trial results show that Givlaari offers sustainable benefit to AIP patients and confirm its favorable safety profile. The treatment came with an initial price tag of $39,000 per vial, which amounts to a total of $575,00 each year. Clinical trial results have shown that Givlaari reduces severe AIP symptoms by 74 percent.

Gene Silencing

Gene Silencing Gene Clinical Trials Clinical Trials

Grand Rounds February 17, 2023: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials (C. Michael Gibson, MS, MD)

Rethinking Clinical Trials

FEBRUARY 22, 2023

It will demonstrate that we can do trials at less cost than a normal trial (about 1% of a normal study). The question is can we pivot from very expensive trials to test cardiovascular drugs to at least a hybrid model that takes the best of what we have learned so far from the Heartline Trial?

Clinical Trials

Clinical Trials Clinical Trials Trials Nurses

Life Sciences 2022 Year in Review

XTalks

DECEMBER 21, 2022

This included greater adoption and acceptance of decentralized clinical trial models, emphasis on patient-centric approaches in trials, growing digitization of healthcare and dealing with drug manufacturing challenges. Decentralized and Virtual Clinical Trials. million for a single infusion.

Life Science

Life Science Gene Therapy Gene Clinical Trials

A roadmap for adopting New Science

pharmaphorum

JUNE 15, 2021

The adoption of New Science – a unique combination of the best in science and health technology that address significant unmet patient needs – is delivering more precise and effective treatments, but often at a higher price tag, according to new research. And 65% of pharma sales rep meetings were held virtually.

Clinical Trials

Clinical Trials Clinical Trials Development Marketing

Clinical Research Informer

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

Grand Rounds March 3, 2023: Adoption, Implementation and Sustainment of Family-focused Prevention in Health Care Systems: How Do We Get There? (Margaret Kuklinski, PhD; Stacy Sterling, DrPH, MSW)

Trending Sources

Grand Rounds July 7, 2023: Implementing Virtual Strategies Across an Integrated Healthcare System: The IMPLEMENT-HF Study (Ankeet S. Bhatt, MD, MBA, ScM)

Grand Rounds October 28, 2022: The HERO (Healthcare Worker Exposure Response & Outcomes) Program: An Online Community to Support Observational Studies, Randomized Trials, and Long-Term Safety Surveillance (Emily O’Brien, PhD, FAHA; Russell Rothman, MD, MPP)

Grand Rounds August 19, 2022: Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change (Gerald Bloomfield, MD, MPH; Michelle Kelsey, MD)

Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH)

Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH; Adrian F. Hernandez, MD, MHS)

Medicare savings won’t make a dent in healthcare costs

AI-Powered Precision Engagement in Commercial and Medical Functions

Gene Silencing Porphyria Treatment, Givlaari, Finally Wins Over England’s NICE Amid Stellar Long-Term Data

Grand Rounds February 17, 2023: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials (C. Michael Gibson, MS, MD)

Life Sciences 2022 Year in Review

A roadmap for adopting New Science

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