Clinical Research Informer

Grand Rounds Ethics and Regulatory Series November 11, 2022: Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape (Stephanie Morain, PhD, MPH; Kayte Spector-Bagdady, JD, MBioethics)

Rethinking Clinical Trials

NOVEMBER 16, 2022

As one of the federal departments and agencies with the largest research and development budget, the NIH came out with one of the first federal data sharing policies in 2003 called the NIH Data Sharing Policy and Implementation Guidance. University of Michigan Medical School. Ethics, Data Sharing, Pragmatic Clinical Trials.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Grand Rounds October 6, 2023: Hybrid Studies Should Not Sacrifice Rigorous Methods (David M. Murray, PhD; Moderator: Jonathan Moyer, PhD)

Rethinking Clinical Trials

OCTOBER 11, 2023

Murray, PhD NIH Associate Director for Prevention and Director, NIH Office of Disease Prevention Moderator: Jonathan C. This was an impactful collaboration between NIH investigators and study teams and methodologists. Speakers Speaker: David M. so that people will use the research we’ve done.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Grand Rounds July 15, 2022: Overview of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Public-Private Partnership and Lessons Learned (Stacey J. Adam, PhD)

Rethinking Clinical Trials

JULY 22, 2022

Foundation for the NIH. – Foundation for NIH was involved from the beginning because we had successfully done the public-private partnerships for other initiatives, we had the stakeholder relationships to get everyone to the table, and our involvement allowed for rapid, targeted donations from private sector. . Key Points.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

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

– Can you comment on how this is perceived at NIH and some of the institutes? I am sure NIH is trying to accelerate our understanding of DCTs. From my perspective, if one key goal for NIH is to reach people in underserved communities having sound practices for decentralized methods will be important.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Grand Rounds October 20, 2023: A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists (Rachael L. Fleurence, PhD, MSc; Joshua M. Sharfstein, MD)

Rethinking Clinical Trials

OCTOBER 26, 2023

To address this crisis, the NIH is embarking on a National Initiative on Hepatitis C. Discussion Themes – When did NIH begin to think a program like this was possible? with the rate of reported acute Hepatitis C cases increasing 400% during 2010-2020. Even when diagnosed, only 1 in 3 adults are cured of Hepatitis C in the U.S.

Clinical Research

Clinical Research Clinical Trials Clinical Trials Research

Grand Rounds May 5, 2023: All of Us Research Program: Improving Health Through Diverse Technology, Huge Cohorts, and Precision Medicine (Joshua C. Denny, MD, MS)

Rethinking Clinical Trials

MAY 10, 2023

Denny, MD, MS CEO, All of Us Research Program Slides Keywords Precision Medicine, All of Us Research Program Key Points The mission of the All of Us Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us. Those funds would come from NIH.

Medicine

Medicine Research Clinical Trials Clinical Trials

Grand Rounds December 15, 2023: Diversifying Clinical Trials: A Path Forward (Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC)

Rethinking Clinical Trials

DECEMBER 20, 2023

Yet enrollment of ethnic minorities in NIH clinical trials and for trials studying approved devices and drugs remains low. Globally cardiovascular disease (CVD) prevalence had decreased between 1990 and 2010, but it has slightly increased since 2010.

Clinical Trials

Clinical Trials Clinical Trials Trials Cardiology

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

Participating organizations included FDA, NIH, academic institutions, pharmaceutical and device companies, patient advocacy groups, community groups, and data groups, and representatives from each organization had opportunity to extend invitation to others. Associate Professor with Tenure, Medicine. Associate Professor, Global Health.

Clinical Trials

Clinical Trials Clinical Trials Trials Medicine

Grand Rounds June 16, 2023: BeatPain Utah: Partnering With Community Health Centers Within a Socio-Technical Framework (Julie Fritz, PT, PhD, FAPTA; Guilherme Del Fiol, MD, PhD)

Rethinking Clinical Trials

JULY 9, 2023

BeatPain Utah, an NIH Pragmatic Trials Collaboratory Demonstration Project, is an embedded pragmatic clinical trial comparing the effectiveness of nonpharmacologic intervention strategies for patients with back pain seeking care in federally qualified health centers in Utah.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Grand Rounds Ethics and Regulatory Series February 10, 2023: Informing and Consenting: What Are the Goals? (P. Pearl O’Rourke, MD; David S. Wendler, PhD, MA; Miguel Vazquez, MD; P. Michael Ho, MD, PhD)

Rethinking Clinical Trials

FEBRUARY 16, 2023

Wendler, PhD, MA Senior Researcher Head, Section on Research Ethics Department of Bioethics NIH Clinical Center Miguel Vazquez, MD Professor of Internal Medicine UT Southwestern Medical Center Michael Ho, MD, PhD Professor of Medicine University of Colorado School of Medicine Slides Keywords Ethics and Regulatory, Consent, Waiver of Consent, Notification (..)

Clinical Trials

Clinical Trials Clinical Trials Medicine Trials

How to Apply for A Clinical Trial On FindMeCure

Find Me Cure

APRIL 16, 2020

With 85% of patients unaware of clinical trials as an option at the time of their diagnosis, according to the NIH , it’s a shame that many parts of the application process are still needlessly complicated when a patient is aware and motivated. A good example of a keyword is the treatment you know they are testing.

Clinical Trials

Clinical Trials Clinical Trials Trials Doctors

Novel method predicts if COVID-19 clinical trials will fail or succeed

Bioengineer

JULY 21, 2021

The study, published in PLOS ONE , provides the most extensive set of features for clinical trial reports, including features to model trial administration, study information and design, eligibility, keywords, drugs and other features. In total, 693 dimensional features were created to represent each clinical trial.

Clinical Trials

Clinical Trials Clinical Trials Trials Engineer

Grand Rounds November 3, 2023: The Perils and Pitfalls of Complex Clustering in Pragmatic Trials (Jonathan Moyer, PhD; Moderator: Andrea Cook, PhD)

Rethinking Clinical Trials

NOVEMBER 6, 2023

Moyer, PhD Statistician, NIH Office of Disease Prevention Moderator: Andrea J. Speaker Jonathan C.

Trials

Trials Clinical Trials Clinical Trials Contamination

Clinical Research Informer

Grand Rounds Ethics and Regulatory Series November 11, 2022: Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape (Stephanie Morain, PhD, MPH; Kayte Spector-Bagdady, JD, MBioethics)

Grand Rounds October 6, 2023: Hybrid Studies Should Not Sacrifice Rigorous Methods (David M. Murray, PhD; Moderator: Jonathan Moyer, PhD)

Trending Sources

Grand Rounds July 15, 2022: Overview of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Public-Private Partnership and Lessons Learned (Stacey J. Adam, PhD)

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

Grand Rounds October 20, 2023: A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists (Rachael L. Fleurence, PhD, MSc; Joshua M. Sharfstein, MD)

Grand Rounds May 5, 2023: All of Us Research Program: Improving Health Through Diverse Technology, Huge Cohorts, and Precision Medicine (Joshua C. Denny, MD, MS)

Grand Rounds December 15, 2023: Diversifying Clinical Trials: A Path Forward (Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC)

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 June 16, 2023: BeatPain Utah: Partnering With Community Health Centers Within a Socio-Technical Framework (Julie Fritz, PT, PhD, FAPTA; Guilherme Del Fiol, MD, PhD)

Grand Rounds Ethics and Regulatory Series February 10, 2023: Informing and Consenting: What Are the Goals? (P. Pearl O’Rourke, MD; David S. Wendler, PhD, MA; Miguel Vazquez, MD; P. Michael Ho, MD, PhD)

How to Apply for A Clinical Trial On FindMeCure

Novel method predicts if COVID-19 clinical trials will fail or succeed

Grand Rounds November 3, 2023: The Perils and Pitfalls of Complex Clustering in Pragmatic Trials (Jonathan Moyer, PhD; Moderator: Andrea Cook, PhD)

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