Clinical Research Informer

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. There are several strategies that will help increase diversity in CVD trials. CVD is the leading cause of mortality in women. We have to change how we are practicing.

Clinical Trials

Clinical Trials Clinical Trials Trials Cardiology

New approach to improving clinical trial enrollment and diversity

Medical Xpress

MARCH 8, 2023

Before new therapies can reach patients, they must be tested in clinical trials in representative populations to show that they work and are safe. Failure to enroll enough participants in trials can delay the arrival of new therapies in the clinic and inflate their eventual price tags.

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

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

Diversity, Inclusion. 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. population at large, which is steadily becoming more diverse. Duke University School of Medicine. Key Points.

Clinical Trials

Clinical Trials Clinical Trials Trials Medicine

Grand Rounds October 27, 2023: Digital, Decentralized and Democratized: Lessons From The Yale PaxLC Trial (Harlan M. Krumholz, MD, SM)

Rethinking Clinical Trials

OCTOBER 31, 2023

PaxLC brings together many innovations including online screening, digital medical record review, e-consent, home-delivery of medications, local clinical blood draws, home-based biospecimen collection, online diaries and surveys, digital medical record outcomes, and participant-centricity, and return of results. It’s a multipronged strategy.

Trials

Trials Medicine Research Clinical Trials

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

Rethinking Clinical Trials

APRIL 18, 2023

This broad set of clinical conditions and varied underlying causes underscore the need for testing a broad portfolio of therapeutic agents. The 5 trials, RECOVER-VITAL, RECOVER-AUTONOMIC, RECOVER-SLEEP, RECOVER-NEURO, and RECOVER-ENERGIZE, will enroll about 2,600 total participants, and each trial will include between 25-100 sites.

Clinical Trials

Clinical Trials Clinical Trials Trials Immune Response

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

Clinical research can exacerbate disparities, because clinical trials typically are based in urban, academic medical centers, underrepresent diverse populations, and overlook community engagement strategies in trial planning and design. The clinic’s priorities should drive the design of the trial. “We

Clinical Trials

Clinical Trials Clinical Trials Trials 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

Duke Clinical Research Institute. On March 21, 2020, in response to the COVID-19 pandemic, PCORI contacted leadership at Duke Clinical Research Institute and PCORnet and a decision was made to focus on the space of healthcare workers. ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?. Speakers.

Trials

Trials Clinical Research Vaccination Vaccine

Grand Rounds March 1, 2024: Effect of an Intensive Food-As-Medicine Program on Health and Health Care Use: Evidence from a Randomized Clinical Trial (Joseph Doyle, PhD)

Rethinking Clinical Trials

MARCH 6, 2024

Schell Professor of Management and Applied Economics MIT Sloan School of Management Slides Keywords Food-as-Medicine, Randomized Clinical Trial, Diabetes Key Points Diabetes is common and costly. Clinic staff included a dietitian, a nurse and a community health worker. The trial was for adults with HbA1c greater than 8.0,

Clinical Trials

Clinical Trials Clinical Trials Medicine Trials

Grand Rounds July 22, 2022: ACTIV-6: 1-Year Later and Trial Results for Ivermectin-400 and Inhaled Fluticasone (Susanna Naggie, MD, MHS)

Rethinking Clinical Trials

JULY 27, 2022

Vice Dean for Clinical Research. The key clinical questions of the ACTIV-6 study are: how to help someone feel better faster with newly diagnosed mild-moderate COVID-19 and how to prevent hospitalizations or death in someone with newly diagnosed mild-moderate COVID-19? We did not see as much diversity in this decentralized trial.

Trials

Trials Pharmacy Medicine Clinical Trials

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

Ethics, Data Sharing, Pragmatic Clinical Trials. When you apply these rules to pragmatic clinical trials (PCTs), there are ethical challenges because PCTs often use waivers or alterations of informed consent and are embedded into ongoing clinical care using extant data. University of Michigan Medical School.

Clinical Trials

Clinical Trials Clinical Trials 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

The program will nurture partnerships for decades with at least a million participants who reflect the diversity of the U.S.; Participation in All of Us is open to all and reflects the rich diversity of the U.S. By the end of 2026, the goal is to reach 1 million participants who reflect the diversity of the U.S.,

Medicine

Medicine Research Clinical Trials Clinical Trials

Grand Rounds August 12, 2022: Equitably Including Diverse Participants in Pragmatic Clinical Trials (Consuelo H. Wilkins, MD, MSCI)

Rethinking Clinical Trials

AUGUST 18, 2022

Equity, Diversity, Recruitment. The Trial Innovation Network Recruitment Innovation Center aims to positively impact human health by improving participant enrollment and retention in multi-center clinical trials. Study design and approach should support diversity goals. for Health Equity and Inclusive Excellence.

Clinical Trials

Clinical Trials Clinical Trials Trials Insulin

Grand Rounds June 9, 2023: Emulating Randomized Clinical Trials with Non-randomized Real-world Evidence Studies: Results From The RCT DUPLICATE Initiative (Shirley V. Wang, PhD)

Rethinking Clinical Trials

JUNE 14, 2023

The first aim of the project is to use healthcare databases to emulate the design of 30 completed trials and predict the results of 7 ongoing trials. The first aim of the project is to use healthcare databases to emulate the design of 30 completed trials and predict the results of 7 ongoing trials.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Grand Rounds January 27, 2023: The PREPARE II Trial: Embedding a Pragmatic Trial Into Clinical Care During an Emergency Procedure (Derek W. Russell, MD; Matthew W. Semler, MD, MSc)

Rethinking Clinical Trials

FEBRUARY 2, 2023

This results in arbitrary variation in clinical care. The PrePARE Trial tested the initiation of a 500 mL crystalloid fluid bolus before induction in 9 U.S. The trial had 1:1 randomization in blocks of 2, 4, & 6, stratified by site. In clinical care, patients are receiving treatments that are ineffective (or harmful).

Trials

Trials Clinical Trials Clinical Trials Medicine

A broad range of unmet needs remains in the immuno-oncology space

Pharmaceutical Technology

MAY 2, 2023

IO therapies come with a hefty price tag, with ICI therapies in the US typically exceeding $100,000, while cell therapies can exceed $400,000. There is currently a rich and diverse IO pipeline that aims to address these unmet needs, with 703 IO products currently in clinical trials.

Genetic Engineering

Genetic Engineering Antibody Clinical Trials Clinical Trials

Grand Rounds November 4, 2022: The CardioNerds Clinical Trials Network: Pairing Equitable Enrollment with Trainee Development (Amit Goyal, MD, MAS)

Rethinking Clinical Trials

NOVEMBER 9, 2022

Interventional/Structural Fellow, Cleveland Clinic. Clinical Trial, Medical Education. The goal of the CardioNerds Clinical Trials Network is to pair equitable enrollment with trainee development. Like many trials during the COVID-19 pandemic, there were significant challenges and recruitment delays.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

Grand Rounds November 17, 2023: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: Results from the Nudge Study (Michael Ho, MD, PhD; Sheana Bull, PhD)

Rethinking Clinical Trials

NOVEMBER 21, 2023

The Year 1, UG3 Phase, aims were to develop and program a nudge message library using iterative N of 1 studies to optimize content for a range of diverse patients. Three healthcare delivery systems participated in the study: UC Health Clinics, Denver Health, and VA Eastern Colorado HCS Clinics.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

Grand Rounds December 16, 2022: The Use of EHR-Agnostic Clinical Decision Support to Prevent Thromboembolism in Hospitalized Medically Ill Patients (Alex C. Spyropoulos, MD, FACP, FCCP, FRCPC; Jeffrey Solomon, BFA)

Rethinking Clinical Trials

FEBRUARY 9, 2023

The study team’s health informatics group developed a novel clinical decision support (CDS) tool, called IMPROVE-DD VTE CDS, which can be integrated into different electronic health record (EHR) systems. The team also engaged with a diverse array of providers from multiple hospitals and specialties.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

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).

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Grand Rounds Ethics and Regulatory Series September 9, 2022: Building An Academic Learning Health System: Why Is It So Hard? (Steven Joffe, MD, MPH)

Rethinking Clinical Trials

SEPTEMBER 16, 2022

Dr. Joffe and his collaborators conducted a preliminary study of qualitative interviews, funded by PCORI, with 99 leaders of 16 geographically diverse Learning Health Systems. The opportunity is there given the data available in the EHR and the ability to implement pragmatic clinical trials. The argument for LHS model is strong.

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

The physician-pharmacist team developed recommendations using an algorithm that was supported by the ACC, AHA clinical practice guidelines. Discussion Themes – How diverse were the settings where this was tested? Bhatt, MD, MBA, ScM) appeared first on Rethinking Clinical Trials.

Clinical Trials

Clinical Trials Clinical Trials Scientist Research

AI-Powered Precision Engagement in Commercial and Medical Functions

Intouch Solutions

APRIL 11, 2024

Pre-Clinical : Deeper comprehension of the impacts and outcomes associated with a particular drug. Clinical : Optimized efficiency, inventory management, and service quality of clinical trials. Manufacturing : Improved operations, efficiency, and production costs.

Compliance

Compliance Marketing Drugs Pharma Companies

Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease

The Pharma Data

OCTOBER 9, 2021

This designation is predicated on data showing that gantenerumab significantly reduced brain amyloid pillar, a pathological hallmark of Notice, in the ongoing SCarlet RoAD and Marguerite RoAD open- tag extension trials, as well as other studies. Both trials are expected to be completed in the second half of 2022.

Antibody

Antibody In-Vitro Trials Development

Pharma By The Numbers: A Retrospective Look at the Industry and 20 Years of Xtalks History

XTalks

MARCH 22, 2023

In October 2022, Xtalks celebrated two decades of bringing diverse stakeholders in the life science industry together through first holding physical events, then soon after, hosting exclusively online events. In addition, nearly half of all new drugs launched between 2020 and 2021 came with a price tag of $150,000 per year, or more.

Life Science

Life Science Drugs FDA Approval Vaccination

A history of Pfizer

pharmaphorum

DECEMBER 2, 2020

It almost hadn’t made it through clinical development, facing problems with ineffective chiral isomers and limited efficacy in animal testing, but showed such impact in human trials that it blew the competition away. Likewise, tanezumab, an anti-osteoarthritic, failed in trials. The post A history of Pfizer appeared first on.

Sales

Sales Production Drugs Marketing

Company Spotlight: Cue Biopharma Innovates in the Immunotherapy Space with its Immuno-STAT Platform

XTalks

AUGUST 17, 2020

Cue Biopharma is a Cambridge, Massachusetts-based clinical-stage biotechnology company that is focused on developing injectable immune biologics using its proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform. Promising Clinical Results. Targeting HPV-Induced Head and Neck Cancer.

Protein

Protein Engineer Immune Response In-Vivo

Leveraging flow cytometry in drug discovery

Drug Discovery World

OCTOBER 21, 2022

The main principle involves a well-defined light source such as that produced by lasers that excites fluorescent tags bound to the cells or particles present in a sample. When planning a new flow cytometry experiment, the term compensation may be intimidating to those attempting to run their first trial. Future directions .

Reagent

Reagent Antibody Drugs Protein

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

In addition, we have achieved important clinical, regulatory and commercial milestones across our pipeline and portfolio while also continuing to increase our capacity to supply urgently-needed doses of BNT162b2 to the world. Clinical and Research Developments. Hospital products, which grew 10% operationally to $2.3

Vaccination

Vaccination Vaccine Production Sales

Clinical Research Informer

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

New approach to improving clinical trial enrollment and diversity

Trending Sources

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 October 27, 2023: Digital, Decentralized and Democratized: Lessons From The Yale PaxLC Trial (Harlan M. Krumholz, MD, SM)

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

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 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 March 1, 2024: Effect of an Intensive Food-As-Medicine Program on Health and Health Care Use: Evidence from a Randomized Clinical Trial (Joseph Doyle, PhD)

Grand Rounds July 22, 2022: ACTIV-6: 1-Year Later and Trial Results for Ivermectin-400 and Inhaled Fluticasone (Susanna Naggie, MD, MHS)

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 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 August 12, 2022: Equitably Including Diverse Participants in Pragmatic Clinical Trials (Consuelo H. Wilkins, MD, MSCI)

Grand Rounds June 9, 2023: Emulating Randomized Clinical Trials with Non-randomized Real-world Evidence Studies: Results From The RCT DUPLICATE Initiative (Shirley V. Wang, PhD)

Grand Rounds January 27, 2023: The PREPARE II Trial: Embedding a Pragmatic Trial Into Clinical Care During an Emergency Procedure (Derek W. Russell, MD; Matthew W. Semler, MD, MSc)

A broad range of unmet needs remains in the immuno-oncology space

Grand Rounds November 4, 2022: The CardioNerds Clinical Trials Network: Pairing Equitable Enrollment with Trainee Development (Amit Goyal, MD, MAS)

Grand Rounds November 17, 2023: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: Results from the Nudge Study (Michael Ho, MD, PhD; Sheana Bull, PhD)

Grand Rounds December 16, 2022: The Use of EHR-Agnostic Clinical Decision Support to Prevent Thromboembolism in Hospitalized Medically Ill Patients (Alex C. Spyropoulos, MD, FACP, FCCP, FRCPC; Jeffrey Solomon, BFA)

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)

Grand Rounds Ethics and Regulatory Series September 9, 2022: Building An Academic Learning Health System: Why Is It So Hard? (Steven Joffe, MD, MPH)

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

AI-Powered Precision Engagement in Commercial and Medical Functions

Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease

Pharma By The Numbers: A Retrospective Look at the Industry and 20 Years of Xtalks History

A history of Pfizer

Company Spotlight: Cue Biopharma Innovates in the Immunotherapy Space with its Immuno-STAT Platform

Leveraging flow cytometry in drug discovery

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

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