Clinical Research Informer

Grand Rounds January 26, 2024: Advancing the Safe, Effective and Equitable Use of AI in Healthcare (Mark Sendak, MD, MPP; Suresh Balu, MD, MBA)

Rethinking Clinical Trials

JANUARY 31, 2024

The main deliverables for the first phase of the project were developing standard key decision points for the AI product lifecycle and developing the Health Equity Across the AI Lifecycle (HEAAL) Framework. Key decision point 1 is procurement. The next key decision point is clinical integration.

Production

Production Development Clinical Trials Clinical Trials

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

There is a lack of point-of-care diagnostics; it can take up to 3 steps to treatment initiation. The treatment is not a routine part of primary care, and there is an underserved and hard-to-reach population. with the rate of reported acute Hepatitis C cases increasing 400% during 2010-2020. The initiative would bring to the U.S.

Clinical Research

Clinical Research Clinical Trials Clinical Trials Research

Grand Rounds February 9, 2024: Pragmatic Recruitment of Underrepresented Groups – Experience From the Diuretic Comparison Project (Cynthia Hau, MPH)

Rethinking Clinical Trials

FEBRUARY 14, 2024

DCP developed an EHR-based workflows and integrated workflows within the local VA primary care setting. There was a lot of work that went into startup, making sure incentives were aligned across the VA system, meetings with primary care, cardiology, the VA ethics office, and ultimately with the central IRB.

Clinical Trials

Clinical Trials Clinical Trials Cardiology Trials

Upcoming sickle cell gene therapies cost effective at $2 million, says ICER

Pharmaceutical Technology

APRIL 13, 2023

Two gene therapies up for approval this year for sickle cell disease could be cost effective in some cases at a $2 million price point, based on a draft evidence report published by the Institute for Clinical and Economic Review (ICER). The standard of care for the condition includes blood transfusions, hydroxyurea and iron chelation.

Gene Therapy

Gene Therapy Gene FDA Approval Licensing

Grand Rounds December 1, 2023: Guidelines for Design and Analysis of Stepped-Wedge Trials (James P. Hughes, PhD)

Rethinking Clinical Trials

DECEMBER 6, 2023

Hughes, PhD Professor Emeritus of Biostatistics, University of Washington Slides Keywords Design, Analysis, Stepped-Wedge Trial Key Points Stepped-wedge design is typically run by clusters that are randomized. At this point it is an open question for how big of a practical problem this is. -In Speaker James P.

Trials

Grand Rounds December 8, 2023: A Pragmatic Randomized Trial of the Jumpstart Intervention to Promote Communication about Goals of Care for Hospitalized Patients with Serious Illness (Ruth Engelberg, PhD; Erin Kross, MD; Robert Lee, MD, MS)

Rethinking Clinical Trials

DECEMBER 12, 2023

And yet goals of care discussions and their documentation remain a shortcoming in many health systems. It has been studied in prior contexts in a PCORI trial and a pilot inpatient trial where the intervention increased goals of care discussions from 8% to 21%. The Jumpstart intervention is a communication-priming intervention.

Trials

Trials Medicine Clinical Trials Clinical Trials

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 is renewed interest in implementation science in cardiometabolic care to better understand optimal pathways for delivering these therapies in patients with HFrEF. They made only one suggestion a day for how to optimize the patient’s care, such as initiation of one therapy or an up titration of an existent therapy.

Clinical Trials

Clinical Trials Clinical Trials Scientist Research

Medicare savings won’t make a dent in healthcare costs

World of DTC Marketing

SEPTEMBER 9, 2021

Hospitals receive $1 out of every $3 spent on health care, and the United States is projected to spend about $1.3 trillion for hospital care alone in 2019. Across America’s acute care hospitals, total revenues exceeded expenses by more than $64 billion in 2016, according to a Center for American Progress analysis.

Drugs

Drugs Pharmacy Clinical Trials Clinical Trials

Grand Rounds Biostatistics Series January 5, 2024: Methods for Handling Missing Data in Cluster Randomized Trials (Rui Wang, PhD; Moderator: Fan Li, PhD)

Rethinking Clinical Trials

JANUARY 9, 2024

That’s a great point. Tags #pctGR, @Collaboratory1 The post Grand Rounds Biostatistics Series January 5, 2024: Methods for Handling Missing Data in Cluster Randomized Trials (Rui Wang, PhD; Moderator: Fan Li, PhD) appeared first on Rethinking Clinical Trials. It’s difficult to gauge what kind of bias this introduces.

Trials

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

SEPTEMBER 13, 2023

DEVICE, part of the Pragmatic Critical Care Research Group, was a multicenter, parallel-group, unblinded pragmatic, randomized trial compared the use of a video laryngoscope with the use of a direct laryngoscope for tracheal intubation of critically ill adults at 17 EDs and ICUs across U.S.

Trials

June 24, 2022: FDA Draft Guidance on Real-World Evidence (John Concato, MD, MS, MPH)

Rethinking Clinical Trials

JUNE 29, 2022

Key Points. Real-world data (RWD) is a term with specific regulatory implications referring to health care data routinely collected from a variety of sources. Big data; Real-word evidence; Real-world data; 21st Century Cures Act; FDA Draft Guidance. Discussion Themes. and the FDA Draft Guidance for RWD/RWE. pctGR, @Collaboratory1.

Big Data

Big Data Clinical Trials Clinical Trials Drugs

Grand Rounds October 7, 2022: Impact Of Handovers Of Anesthesia Care On Morbidity And Mortality (Melanie Meersch-Dini, MD)

Rethinking Clinical Trials

OCTOBER 13, 2022

Department of Anesthesiology, Intensive Care and Pain Medicine. Key Points. There is an increasing frequency of surgical procedures and the need for anesthesia care, and the number of care transitions is increasing. Are the results generalizable to all patient cohorts and to other health care systems?

Trials

Trials Clinical Trials Clinical Trials Nurses

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

Grand Rounds June 30, 2023: Decentralized Trials – From Guidance to Reality & What’s Left (Adrian Hernandez, MD, MHS; Pamela Tenaerts, MD, MPH; Craig Lipset, MPH)

Rethinking Clinical Trials

JULY 6, 2023

For instance, there is no discussion of the role of the health care provider in the DCTs, but it emphasizes the importance of patient voice. The key remaining issues for DCTs include clarification around the roles and responsibilities of health care providers as well as principal investigator (PI) oversight and responsibility.

Trials

Trials Clinical Trials Clinical Trials Licensing

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

Grand Rounds September 29, 2023: Navigating the Use of Patient-Reported Outcomes in Research and Practice: The PROTEUS Consortium (Claire Snyder, PhD; Norah Crossnohere, PhD; Anne Schuster, PhD)

Rethinking Clinical Trials

OCTOBER 2, 2023

The PROTEUS-Practice Guide offers support for designing, implementing, and managing PRO systems in clinical care. The PROTEUS website has web tutorials, checklists, and a handbook on topics such as displaying data for patients and clinicians and researchers. We are pursuing funding.

Clinical Trials

Clinical Trials Clinical Trials Research Trials

Cartherics grants licence for CTH-004 to Shunxi

Pharmaceutical Technology

MAY 1, 2023

CTH-004 is developed by genetically altering patient T cells for inserting a chimeric antigen receptor (CAR) to target a marker (TAG-72) on ovarian cancer cells and delete genes which are involved in T cell function suppression. Shunxi will also hold an option to negotiate rights to other CAR-T products, which include the licenced IP.

Gene Therapy

Gene Therapy Gene Development Clinical Trials

Grand Rounds January 20, 2023: Collaborative Pragmatic Trials in Action: EVOLVE-MI (Mikhail Kosiborod, MD)

Rethinking Clinical Trials

JANUARY 26, 2023

Participants within 10 days of index MI will either receive Evolocumab (140mg Q2W) every two weeks plus routine clinical care or standard of care. Study participants are managed within health systems in-line with local standard of care. EVOLVE-MI is enrolling 4,000 patients in 3 countries.

Trials

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

Key Points. Six agents showed really good results and either changed clinical practice or showed efficacy and improved patient care. Read more in Annals of Internal Medicine and Critical Care Medicine. ? ? ? ? ? ? ? ? ? ? ? ?. Speaker. Associate Vice President, Research Partnerships. Foundation for the NIH. Discussion Themes.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

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. They also screened for complications and close care gaps. Speaker Joseph Doyle, PhD Erwin H. 9% of the U.S.

Clinical Trials

Clinical Trials Clinical Trials Medicine Trials

Grand Rounds February 24, 2023: S2302 Pragmatica-Lung: New Directions for Decreasing Burden and Increasing Inclusion in NCTN Clinical Trials (Konstantin Dragnev, MD; Karen Reckamp, MD, MS)

Rethinking Clinical Trials

MARCH 1, 2023

S1800A was a Phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for NSCLC patients previously treated with immunotherapy performed within the Lung-MAP platform. months, for pembrolizumab and ramucirumab vs. standard of care, respectively.

Clinical Trials

Clinical Trials Clinical Trials Trials Packaging

Grand Rounds July 14, 2023: Lessons From the COORDINATE-Diabetes Trial (Christopher B. Granger, MD; Neha J. Pagidipati, MD, MPH)

Rethinking Clinical Trials

JULY 19, 2023

The first group consisted of a usual care arm, where they received basic guidelines for treating diabetes or ASCVD. In the usual care arm sites, 14.5% Is there a reason for the disproportionate number of participants between the usual care and intervention groups? in which participants had type 2 diabetes mellitus and ASCVD.

Trials

Trials Cardiology Medicine Nurses

Grand Rounds February 2, 2024: Strategies for Improving Public Understanding of FDA and the Products It Regulates…Why Should We Care, and What Might We Do? (Susan C. Winckler, RPh, Esq)

Rethinking Clinical Trials

FEBRUARY 7, 2024

Food and Drug Administration, FDA, Misinformation, Communication, Health Information Key Points U.S. Potential strategy: Increase regular communication with health care professionals. Winckler, RPh, Esq Chief Executive Officer Reagan-Udall Foundation for the FDA Slides Keywords U.S.

Regulation

Regulation Production Clinical Trials Clinical Trials

Grand Rounds February 3, 2023: Pragmatic Trials For Children With Congenital Heart Disease – Insights From The NITRIC Trial (Luregn Schlapbach, PhD, FCICM)

Rethinking Clinical Trials

FEBRUARY 13, 2023

There was no change in perioperative care. The hypothesis was that patients with nitric oxide would recover quicker allowing for more ventilator-free days, but there was no difference between the intervention and standard of care. There was no use of nitric oxide (NO) during CPB controls. There were a number of limitations.

Trials

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

There are also concerns that obtaining consent could alter the “real-world” medical care being studied, may introduce an alteration of routine care, may introduce bias or make research impossible to conduct. The intervention was to facilitate delivery of guideline-based care. Informed consent is not the only way to inform.

Clinical Trials

Clinical Trials Clinical Trials Medicine Trials

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

MAY 19, 2023

Colwill Professor and Vice Chair Department of Family and Community Medicine University of Missouri Slides Keywords Electronic Health Record, Pragmatic Clinical Trial Key Points Patients bring patient-generated home blood pressure data into the clinical workflow. Vanderbilt has a plan for bridging this gap through care managers.

Trials

Grand Rounds November 18, 2022: The FIRST-ABC Pragmatic Trials of Non-Invasive Respiratory Support In Children (Padmanabhan Ramnarayan, MBBS, MD, FRCPCH, FFICM)

Rethinking Clinical Trials

NOVEMBER 21, 2022

Reader in Pediatric Critical Care. Key Points. The difficulty with pediatric respiratory support is that the step-up and step-down of respiratory care is very evidence poor even though these therapies are used commonly. acutely ill patients) and step-down, which is the extubation or post-extubation part of the care pathway.

Trials

Trials Clinical Trials Clinical Trials Packaging

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

Key Points. There was some evidence of increased acute care needs (urgent care, emergency room visit) in the fluticasone furoate arm. Professor of Medicine. Vice Dean for Clinical Research. Duke University School of Medicine. ACTIV, ACTIV-6, COVID-19, Ivermectin, Inhaled Fluticasone. No safety concerns were identified.

Trials

Trials Pharmacy Medicine Clinical Trials

Grand Rounds September 23, 2022: Effect Of An Intensive Nurse Home Visiting Program On Adverse Birth Outcomes In A Medicaid-Eligible Population (Margaret McConnell, PhD)

Rethinking Clinical Trials

SEPTEMBER 30, 2022

Key Points. The types of services NFP nurses provide include health assessments, such as prenatal health assessment, monitoring weight and blood pressure; screening for depression, anxiety, intimate partner violence; referrals to health care providers and community resources; educational content; and psychosocial support. Harvard T.H.

Nurses

Nurses Trials Clinical Trials Clinical Trials

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

Key Points. The LHS were identified by AAMC Research on Care Community, self-descriptions, and snowball referrals, and they included LHS that are medical school affiliated and non-affiliated, safety net systems, and children’s hospitals. Art and Ilene Penn Professor and Chair. Department of Medical Ethics & Health Policy.

Clinical Trials

Grand Rounds April 21, 2023: Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-randomised Trial (Amit Garg, MD, MA, FRCPC, FACP, PhD; Stephanie N. Dixon, PhD MSc)

Rethinking Clinical Trials

APRIL 27, 2023

In a recent international survey of more than 270 centers, nearly half now use a cooler temperature dialysate in patient care of less than or equal to 36.0 After MyTEMP, centers in Ontario stopped adopting colder temperature dialysate as a center-wide policy, and patients felt less discomfort during hemodialysis care. degrees Celsius.

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

Key Points. 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. Associate Director, Center for Bioethics & Social Sciences in Medicine. pctGR, @Collaboratory1.

Clinical Trials

Grand Rounds August 4, 2023: AI & ML: Want to Play a Game? (Eric Perakslis, PhD)

Rethinking Clinical Trials

AUGUST 10, 2023

However, gamification could have serious negative effects, and the benefits of these games in health care would relate to how well or how poorly they’re gamified, based on data, execution, and use cases. Tags #pctGR, @Collaboratory1 The post Grand Rounds August 4, 2023: AI & ML: Want to Play a Game?

Clinical Trials

Clinical Trials Clinical Trials Trials Medicine

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

This trial tested the hypothesis that the use of a platform-agnostic, EHR-embedded VTE risk model with integrated CDS would 1) increase rates of appropriate Thromboprophylaxis, and subsequently 2) reduce thromboembolism, compared to usual medical care in hospitalized, medically-ill patients.

Clinical Trials

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

JANUARY 17, 2024

The committee worked with communications specialists who partnered with palliative care providers and others to draft FAQs and other communication guidance for clinician teams who were having conversations about drug allocations with patients and families. There was a daily process for the Remdesivir lottery.

Clinical Trials

Clinical Trials Clinical Trials Antibody Trials

Grand Rounds June 2, 2023: PROACT Xa and The Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial (John Alexander, MD, MHS)

Rethinking Clinical Trials

JUNE 7, 2023

The trial was designed to randomize 1,000 patients who had an On-X aortic valve replacement at least 3 months prior to randomization with either a standard dose of Apixaban (5mg) or continued warfarin (the standard of care). The drugs were administered open label and all patients were given a low dose of aspirin.

Clinical Trials

Clinical Trials Clinical Trials Trials Cardiology

Grand Rounds April 28, 2023: Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation: An Embedded Cluster-crossover Trial (Matthew W. Semler, MD, MSc)

Rethinking Clinical Trials

MAY 5, 2023

Assistant Professor of Medicine and Biomedical Informatics Medical Director, VICTR Center for Learning Healthcare Vanderbilt University Medical Center Slides Keywords Pragmatic Clinical Trials, Cluster-crossover Trial Key Points More than 3 million adults receive invasive mechanical ventilation each year in the U.S.

Trials

Trials Clinical Trials Clinical 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

Patiens were excluded if they had neither a landline or cell phone, were enrolled in hospice or palliative care, were non-English or Spanish speaking, and residing out of the state of Colorado. Three healthcare delivery systems participated in the study: UC Health Clinics, Denver Health, and VA Eastern Colorado HCS Clinics.

Clinical Trials

Grand Rounds October 21, 2022: Disinformation, Cyberthreat, and Choice: Protecting Patients and Clinical Research From the Digital Triple Threat (Eric Perakslis, PhD; Andrea Downing)

Rethinking Clinical Trials

OCTOBER 27, 2022

Key Points. Health care and the internet are intertwined. There are doable ways to increase cybersecurity in health care. How do we maintain research access when health care access is limited in some of these states. Duke University School of Medicine . Andrea Downing. ePatient and Security Researcher.

Clinical Research

Clinical Research Research Clinical Trials Clinical Trials

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. We wanted to make sure we were encouraging flexibility of design and use of technology, while still highlighting what people need to be careful with.

Clinical Trials

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. We wanted to make sure we were encouraging flexibility of design and use of technology, while still highlighting what people need to be careful with.

Clinical Trials