Clinical Research Informer

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

UPMC set clear criteria based on the published data at the time for who could and could not receive Remdesivir. Setting clear inclusion/exclusion criteria based on highest level clinical evidence is crucial. UPMC established weighted factors for the Remdesivir lottery that were established by the ethics and clinical committee.

Clinical Trials

Clinical Trials Clinical Trials Antibody 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

For the investigational ramucirumab plus pembrolizumab arm, the drugs are administered per FDA package insert and institutional standard in a 21-day cycle under one of the criteria for removal is met. We kept coming back to the one thing we want to know, which is the overall survival.

Clinical Trials

Clinical Trials Clinical Trials Trials Packaging

Are You Ready for GA4? Enhancements for Measuring Engagement

Intouch Solutions

JUNE 27, 2023

Low Engagement Sessions and Rate replaces Bounces and Bounce Rate – Inverse of engaged session rate; users who did not meet the criteria listed for that metric. Based on this new metric and way of reporting, it is vital to partner with a tagging solutions expert to successfully tag the site that follows the GA4 event structure model.

Marketing

Marketing Branding Development

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

Candidate agents were triaged based on concurrent clinical trials, completion of a multiple ascending dose study, and availability of preclinical data before being scored based on predefined criteria. From this review, 11 ACTIV master protocols were developed. Read more in Annals of Internal Medicine and Critical Care Medicine.

Vaccination

Vaccination Vaccine Clinical Trials Clinical 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

The FIRST-ABC trial adopted a pragmatic design with a heterogenous patient cohort where the indication to start NRS was based on physiological criteria, which allowed the results to be applicable to all situations where HFNC is started. Many other trials in the country were behind and everyone else had to stop. pctGR, @Collaboratory1.

Trials

Trials Clinical Trials Clinical Trials Packaging

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

The VA IRB determined DCP was a minimal risk study, with less restrictive eligibility criteria and EHR-based safety and outcome monitoring. At the time, more than 95% of VA patients received hydrochlorothiazide for thiazide-type diuretic.

Clinical Trials

Clinical Trials Clinical Trials Cardiology 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

After enrolling patients for 8 months, the data safety board recommended trial enrollment stop because the prespecified stopping criteria for efficacy had been met. Nearly 2,000 patients were assessed for eligibility and 1,417 patients were enrolled. Successful intubation on the first attempt occurred in 85.1%

Trials

Trials Clinical Trials Clinical Trials Medicine

Grand Rounds May 19, 2023: Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture (Robert O’Toole, MD)

Rethinking Clinical Trials

MAY 25, 2023

Adult patients who fit the inclusion criteria were randomized at the patient level and stratified by treatment site. Tags #pctGR, @Collaboratory1 The post Grand Rounds May 19, 2023: Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture (Robert O’Toole, MD) appeared first on Rethinking Clinical Trials.

Trials

Trials Clinical Trials Clinical Trials Compliance

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

Rethinking Clinical Trials

JANUARY 26, 2023

EVOLVE-MI has several innovations in protocol development, including streamlined inclusion/exclusion criteria, minimal procedures and ability to screen/randomize in the same day, a simplified schedule of events, and streamlined safety.

Trials

Trials Clinical Trials Clinical Trials Medicine

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

The secondary endpoints were individual criteria of the primary endpoint, hospital length of stay and ICU length of stay. The primary endpoint was a composite of all-cause of death, readmission to hospital or major postoperative complications within 30 days. You have to include more centers to reach your goal during the course of the study.

Trials

Trials Clinical Trials Clinical Trials Nurses

Grand Rounds February 16, 2024: Clinical Implications of the MINT Trial: p=0.07 (Jeffrey Carson, MD, MACP)

Rethinking Clinical Trials

FEBRUARY 20, 2024

The team enrolled patients across 144 sites who fit the following criteria: 18 years or older, had an STEMI or NSTEMI, had Types 1, 2, 4b, or 4c MI, and had a hemoglobin concentration of less than 10 g/dL within 24 hours of enrollment. They utilized 2 transfusion strategies, restrictive and liberal.

Trials

Trials Clinical Trials Clinical Trials Medicine

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

It is not uncommon to see waivers of consent in pragmatic clinical trials because many trials meet minimal risk criteria and involve numerous institutions and thousands of subjects. Tags #pctGR, @Collaboratory1 The post Grand Rounds Ethics and Regulatory Series February 10, 2023: Informing and Consenting: What Are the Goals? (P.

Clinical Trials

Clinical Trials Clinical Trials Medicine 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

To be eligible, patients needed to be first-time mothers aged 15 and older who met the income-eligibility criteria for Medicaid and were no more than 28-weeks gestation at enrollment. This was a randomized controlled trial that enrolled 5,670 mothers into the evaluation between 2016 and 2020, with 2/3 allocated to the intervention group.

Nurses

Nurses Trials Clinical Trials Clinical Trials

Grand Rounds Ethics and Regulatory Series January 13, 2023: Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials (Emily A. Largent, JD, PhD, RN)

Rethinking Clinical Trials

JANUARY 19, 2023

Discussion Themes – You noted that the criteria of waivers and alterations gets left out. Tags #pctGR, @Collaboratory1 The post Grand Rounds Ethics and Regulatory Series January 13, 2023: Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials (Emily A. That’s difficult. it can be a barrier.

Trials

Trials Clinical Trials Clinical Trials Research

Grand Rounds December 2, 2022: A Randomized Controlled Trial of Mobile Health Intervention in Heart Failure and Diabetes: Lessons Learned (G. Michael Felker, MD, MHS)

Rethinking Clinical Trials

DECEMBER 6, 2022

We did what we could to make the entry criteria as easy as possible. It was a labor of love; the site payment was low; we asked friends to be sites in the trial. Sites have a lot of trials that are competing. One pays more than another. pctGR, @Collaboratory1.

Trials

Trials Clinical Trials Clinical Trials Compliance

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

Discussion Themes – We run into situations where we are talking to stakeholders and thinking about criteria for waiver of consent and it’s just not right. Learn more Read about the MyTEMP trial in The Lancet. Read about the MyTEMP statistical analysis plan. There is a natural assertion of autonomy.

Trials

Trials Clinical Trials Clinical Trials Medicine

ASH: Argenx cues up a second use for efgartigimod

pharmaphorum

DECEMBER 12, 2022

of the Vyvgart arm and 20% of the placebo group met the criteria for response to ITP, which include a reduction in bleeding episodes in addition to improvements in platelet counts. After 24 weeks, 21.8% All told, 51.2%

Sales

Sales Trials Drugs Antibody

Sarepta’s Elevidys Reaches Finish Line as First Gene Therapy Approved for Duchenne Muscular Dystrophy

XTalks

JUNE 28, 2023

million price tag of Elevidys, a one-time gene therapy. It has taken Sarepta six years to develop Elevidys with several roadblocks in its journey, including two clinical holds due to safety concerns. In a media call, Sarepta CEO Douglas Ingram revealed the $3.2

Gene Therapy

Gene Therapy Gene Protein FDA Approval

Grand Rounds September 16, 2022: Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program (Tor Biering-Sørensen, MD, PhD, MPH)

Rethinking Clinical Trials

SEPTEMBER 22, 2022

The national registries can be used to identify potential study participants who meet specific criteria and the e-BOKs system allows researchers to easily send invitations to potential participants, as well as follow up communications. Learn more. Read about DANFLU-1. pctGR, @Collaboratory1.

Trials

Trials Cardiology Vaccination Vaccine

The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

AUGUST 22, 2021

To help sponsors understand how the FDA uses the eCTD technical validation rules to verify conformance, the FDA developed the technical rejection criteria (TRC) for study data. What Are the Relevant Technical Rejection Criteria Documents? Where Are the Technical Rejection Criteria for Study Data Applied? Criteria Being Verified.

Containment

Containment Bioavailability Cosmetics Packaging

Grand Rounds January 19, 2024: Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials (Pamela S. Douglas, MD, MACC, FASE, FAHA)

Rethinking Clinical Trials

JANUARY 23, 2024

Feasibility and generalizability affect design choices including inclusion/exclusion criteria, flexibility of imaging intervention being tested, guidance/control of subsequent care after imaging, and endpoints and outcomes. Tags #pctGR, @Collaboratory1 The post Grand Rounds January 19, 2024: Why Are Imaging RCTs Different?

Trials

Trials Cardiology 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

Heartline is using direct to patient recruitment and includes real world patients with a broad range of modifiable risk and limited exclusion criteria. Tags #pctGR, @Collaboratory1 The post Grand Rounds February 17, 2023: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials (C.

Clinical Trials

Clinical Trials Clinical Trials Trials Nurses

Grand Rounds March 17, 2023: Remote Symptom Monitoring with Electronic Patient-Reported Outcomes (ePROs) in Oncology (Ethan Basch, MD, MSc)

Rethinking Clinical Trials

MARCH 21, 2023

Learn more Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Discussion Themes – How have clinician views changed in terms of patient-reported symptoms verses clinician understanding of symptoms? You will want a dedicated tool for adverse events.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Grand Rounds Ethics and Regulatory Series October 14, 2022: Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials (Joseph Ali, JD; Tanya Matthews, PhD; Leslie J. Crofford, MD)

Rethinking Clinical Trials

OCTOBER 19, 2022

Due to the low referral rates of fibromyalgia patents to PT (~30%), FM-TIPS had an emergent ethic issue related to patient recruitment and whether the study team could include the American College of Rheumatology criteria to screening to increase eligibility. In the second example, they were not able to. pctGR, @Collaboratory1.

Clinical Trials

Clinical Trials Clinical Trials Trials Medicine

Sanofi offers refunds for Cablivi in novel model for rebates

Pharmaceutical Technology

JANUARY 27, 2023

Over the last few years, as price tags for drugs have continuously increased, the popularity of risk sharing agreements has been increasing at a rate of 24% annual average growth. Furthermore, he said extracting data to validate the criteria for a warranty reimbursement could be an onerous process.

Manufacturing

Manufacturing Drugs Research Analyst FDA Approval

Tackling the Challenges of Limited Resources During a Pandemic

The Pharma Data

MARCH 20, 2021

a predefined plan with strict acceptance criteria. L volumes, even for notoriously difficult liquid classes like the 100% acetonitrile used to store the Tandem Mass Tags (TMT). The diagnostic test is run under. an ISO17025 quality management system, which. requires new instruments be validated according to. If you want to do a lot.

Reagent

Reagent RNA Bioinformatics Medicine

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

Tags #pctGR, @Collaboratory1 The post Grand Rounds June 9, 2023: Emulating Randomized Clinical Trials with Non-randomized Real-world Evidence Studies: Results From The RCT DUPLICATE Initiative (Shirley V. In any trial emulation, researchers encounter design emulation differences in addition to potential sources of bias.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Salesforce Platform Capabilities

Cloudbyz

JUNE 1, 2023

It’s a more flexible tool than the Data Export service, allowing you to export specific sets of data based on criteria you specify. Users can also collaborate on files, add comments, and tag colleagues. Data Loader: Salesforce’s Data Loader can be used for extracting (backup) and loading (restore) data.

Compliance

Compliance Development Branding Production

Clinical Research Informer

Grand Rounds January 12, 2024: Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce Covid-19 Resources (Erin K. McCreary, PharmD, BCIDP)

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)

Trending Sources

Are You Ready for GA4? Enhancements for Measuring Engagement

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

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

Grand Rounds September 8, 2023: The DEVICE Trial: An Embedded, Pragmatic Trial of Emergency Airway Management (Matthew Prekker, MD, MPH; Jonathan Casey, MD, MSc)

Grand Rounds May 19, 2023: Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture (Robert O’Toole, MD)

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

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

Grand Rounds February 16, 2024: Clinical Implications of the MINT Trial: p=0.07 (Jeffrey Carson, MD, MACP)

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)

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)

Grand Rounds Ethics and Regulatory Series January 13, 2023: Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials (Emily A. Largent, JD, PhD, RN)

Grand Rounds December 2, 2022: A Randomized Controlled Trial of Mobile Health Intervention in Heart Failure and Diabetes: Lessons Learned (G. Michael Felker, MD, MHS)

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)

ASH: Argenx cues up a second use for efgartigimod

Sarepta’s Elevidys Reaches Finish Line as First Gene Therapy Approved for Duchenne Muscular Dystrophy

Grand Rounds September 16, 2022: Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program (Tor Biering-Sørensen, MD, PhD, MPH)

The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Grand Rounds January 19, 2024: Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials (Pamela S. Douglas, MD, MACC, FASE, FAHA)

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

Grand Rounds March 17, 2023: Remote Symptom Monitoring with Electronic Patient-Reported Outcomes (ePROs) in Oncology (Ethan Basch, MD, MSc)

Grand Rounds Ethics and Regulatory Series October 14, 2022: Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials (Joseph Ali, JD; Tanya Matthews, PhD; Leslie J. Crofford, MD)

Sanofi offers refunds for Cablivi in novel model for rebates

Tackling the Challenges of Limited Resources During a Pandemic

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)

Salesforce Platform Capabilities

Stay Connected