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. Many high school and college students are moving away from the sciences. 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 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 April 14, 2023: RECOVER in Action – Status of Clinical Trial Protocols (Kanecia Zimmerman, PhD, MD, MPH)

Rethinking Clinical Trials

APRIL 18, 2023

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Immune Response

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 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

It is a decentralized, fully remote trial, and data are largely patient reported. There was a lot of outreach to sites and they embraced the remote trial. One thing that has been a struggle is the diversity in the population and the equity in access to trials. We did not see as much diversity in this decentralized trial.

Trials

Trials Pharmacy Medicine Clinical Trials

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 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. The trial was for adults with HbA1c greater than 8.0, In terms of the types of food they had, they were not especially culturally diverse.

Clinical Trials

Clinical Trials Clinical Trials Medicine 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. Assistant Professor of Obstetrics & Gynecology. Key Points.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

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. Senior Vice President and Senior Associate Dean.

Clinical Trials

Clinical Trials Clinical Trials Trials Insulin

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. Cost-related unmet needs also scored highly.

Genetic Engineering

Genetic Engineering Antibody Clinical Trials Clinical Trials

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 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. More than 13,000 patients were considered eligible for the UH3 trial and more than 9,500 were randomized in the 4 arms, with about 2,300 patients in each of the arms.

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 effectiveness of the intervention was then evaluated through a cluster randomized trial at four academic tertiary hospitals from December 21, 2020 to January 21, 2022. The study team developed the tool using high-quality evidence from randomized trials related to risk factors for subpopulations and guideline recommendations.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

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. How can institutions help move the needle?

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

Discussion Themes – How diverse were the settings where this was tested? Tags #pctGR, @Collaboratory1 The post Grand Rounds July 7, 2023: Implementing Virtual Strategies Across an Integrated Healthcare System: The IMPLEMENT-HF Study (Ankeet S. 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

Clinical : Optimized efficiency, inventory management, and service quality of clinical trials. However, in keeping with the nature of this short article, I will highlight a couple of the most relevant activities: Data Aggregation Strategy and Analysis AI-powered systems gather data from diverse sources.

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

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

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. Discussion Themes – Was there information to the patients so they knew that they were part of the trial? This trial used a mixed approach.

Trials

Trials Clinical Trials Clinical Trials Medicine

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

With several biologics in the pipeline, including one in early stage clinical trials for head and neck cancer, the company is positioned to engineer highly specific biologics against immune targets in the body. The starting dose of CUE-101 in the clinical trial was quite low (60 µg/kg). Cell-Based Immunotherapy vs. Immune Biologics.

Protein

Protein Engineer Immune Response In-Vivo

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

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

Rethinking Clinical Trials

NOVEMBER 9, 2022

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. The fellows were responsible for 45% of enrollment during the time of the trial.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

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

During the presentation, members from across the research team shared how PaxLC implemented all of these innovations through the course of the trial. Is this knowledge generalizable to other similar trials? We had to operate the trial with an institution that would allow zero risk. Using the local Yale IRB was an asset.

Trials

Trials Medicine Research Clinical Trials

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

Vaccine effectiveness in the study will be inferred through immunobridging to the 16 to 25 year-old population in the pivotal Phase 3 trial. In March 2021, Pfizer and BioNTech announced topline results from a pivotal Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection.

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

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

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

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

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 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 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

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 history of Pfizer

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

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

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

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

Leveraging flow cytometry in drug discovery

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

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