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 141

Clinical Trials Clinical Trials Medicine Trials 141

Rethinking Clinical Trials

JANUARY 26, 2023

EVOLVE-MI is a pragmatic, effectiveness outcome trial of Evolocumab dosed within 10 days of a myocardial infarction (MI). Participants within 10 days of index MI will either receive Evolocumab (140mg Q2W) every two weeks plus routine clinical care or standard of care. EVOLVE-MI is enrolling 4,000 patients in 3 countries.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

FEBRUARY 13, 2023

The NITRIC Trial was a double blind, multicenter, randomized, parallel-group trial recruiting at 6 pediatric cardiac surgical centers in Australia, New Zealand, and The Netherlands. The recruitment began in July 2017-April 2022 and 71 percent of approached parents provided consent. There were a number of limitations.

Trials 130

Trials Clinical Trials Clinical Trials Research 130

Rethinking Clinical Trials

DECEMBER 14, 2022

Senior Scientist, Clinical Epidemiology Program. Ethics, Stepped Wedge Cluster Randomized Trial, Study Design. There are two main types of clinical trials: patient randomized trial and cluster randomized trial (CRT). Monica Taljaard, PhD. Ottawa Hospital Research Institute. University of Ottawa. Key Points.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

NOVEMBER 21, 2022

Pragmatic Clinical Trials. In 2016, we published a pilot trial looking at high-flow nasal cannula (HFNC) therapy compared to CPAP in pediatric critical care. The step-up trial started recruitment in August 2019, 1,449 children were eligible, 600 children were randomized, and 595 consented. Imperial College London.

Trials 130

Trials Clinical Trials Clinical Trials Packaging 130

Rethinking Clinical Trials

AUGUST 23, 2022

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. The Duke Clinical Research Institute (DCRI) organized and sponsored a Think Tank to address diversity in clinical trial research.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Medicine 130

Rethinking Clinical Trials

AUGUST 22, 2022

The COVID-OUT Trial is a remotely delivered, Phase 3, de-centralized clinical trial at 6 participating institutions to see if Ivermectin, Metformin or Fluvoxamine would prevent severe COVID-19. Initially, the randomization of the trial was 1:1 Metformin or Placebo. The primary outcome of the trial was negative.

Trials 130

Trials Clinical Trials Clinical Trials Insulin 130

Rethinking Clinical Trials

DECEMBER 6, 2022

Pragmatic Clinical Trials, Heart Failure, Diabetes. The TARGET-HF-DM is a pragmatic multicenter randomized controlled trial held at 6 sites in the U.S. The trial enrolled 187 patients, with 35% women, 47% African American, 10% Hispanic, age 59 years. This trial turned out to be more challenging than anticipated.

Trials 130

Trials Clinical Trials Clinical Trials Compliance 130

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 trial took place at 64 sites, and randomized 863 patients. We never had an amendment to the protocol.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Cardiology 130

Rethinking Clinical Trials

SEPTEMBER 22, 2022

Professor in Translational Cardiology and Pragmatic Randomized Trials. Head of Center for Translational Cardiology and Pragmatic Randomized Trials. DANFLU-1, Pragmatic Clinical Trials. The DECODE trial used registry data to identify patients with chronic kidney disease. Tor Biering-Sørensen, MD, PhD, MPH.

Trials 130

Trials Cardiology Vaccination Vaccine 130

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. Time, cost and failure to recruit trial participants are significant barriers that must be addressed.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

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. Time, cost and failure to recruit trial participants are significant barriers that must be addressed.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Rethinking Clinical Trials

NOVEMBER 21, 2023

The study recruited adult patients diagnosed with 1 or more cardiovascular condition of interest, prescribed at least 1 or more medication of interest, with a refill gap of at least 7 days. Three healthcare delivery systems participated in the study: UC Health Clinics, Denver Health, and VA Eastern Colorado HCS Clinics.

Clinical Trials 141

Clinical Trials Clinical Trials Trials Development 141

Rethinking Clinical Trials

OCTOBER 13, 2022

HandiCAP Trial, Pragmatic Clinical Trial. The HandiCAP trial asked the question do intraoperative handovers of anesthesia care have an impact on patient outcomes? The trial included adults 18 and older, ASA physical status III or IV, who had a major inpatient surgery with an anticipated duration of 2 hours or longer.

Trials 130

Trials Clinical Trials Clinical Trials Nurses 130

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 130

Clinical Trials Clinical Trials Trials Research 130

Rethinking Clinical Trials

SEPTEMBER 21, 2023

The goals of this project were to characterize online food shopping behaviors in an online survey and conduct a randomized clinical trial of behavioral economic strategies on fruit and vegetable purchases in an online grocery store. I think there’s probably a lot of people here who know how difficult it is to recruit people in person.

Clinical Trials 130

Clinical Trials Clinical Trials Sales Trials 130

pharmaphorum

JULY 25, 2022

It showed an overall response rate with Tecvayli of 63%, including 39% complete responses which is a remarkable result given that the patient recruited into the trial were very ill and heavily pre-treated. Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

Antibody 52

Antibody Medicine Drugs Trials 52

XTalks

AUGUST 23, 2021

This is not a debate on approval,” said Stacie Weninger, PhD, president of the F-Prime Biomedical Research Initiative, in a focused topic session on the impact of drug approval on future clinical trials held on Tuesday July 27. Now that [aducanumab] is approved, how will this affect clinical trials going forward?”.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drugs 52

Rethinking Clinical Trials

FEBRUARY 22, 2023

It will demonstrate that we can do trials at less cost than a normal trial (about 1% of a normal study). The question is can we pivot from very expensive trials to test cardiovascular drugs to at least a hybrid model that takes the best of what we have learned so far from the Heartline Trial?

Clinical Trials 130

Clinical Trials Clinical Trials Trials Nurses 130

Rethinking Clinical Trials

OCTOBER 19, 2022

Trials are getting larger and collecting greater volumes of clinical data than ever before, often as part of Common Data Elements (CDEs). extraction from health records and/or have treating clinicians or patients complete measures); and trials may operate under waivers of consent. Chief, Division of Rheumatology. Key Points.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Medicine 130

pharmaphorum

DECEMBER 2, 2020

Pfizer’s international expansion put great trust in their local staff compared to other organisations, recruiting nationals and giving them a great deal of autonomy. Likewise, tanezumab, an anti-osteoarthritic, failed in trials. For all the latest Pfizer news follow pharmaphorum’s Pfizer tag.

Sales 128

Sales Production Drugs Marketing 128

Rethinking Clinical Trials

AUGUST 28, 2023

The IMPACt-LBP study design is a pragmatic, multi-site, two-arm cluster-randomized trial with randomization at the primary care provider (PCP) clinic level. It includes 22 family medicine, primary care and general internal medicine clinics affiliated with Duke University, the University of Iowa or Dartmouth-Hitchcock health systems.

Trials 130

Trials Research Medicine Doctors 130

XTalks

DECEMBER 21, 2022

This included greater adoption and acceptance of decentralized clinical trial models, emphasis on patient-centric approaches in trials, growing digitization of healthcare and dealing with drug manufacturing challenges. Decentralized and Virtual Clinical Trials. million for a single infusion.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

pharmaphorum

OCTOBER 4, 2022

During the first stage of the initiative, more than 2,000 research papers were published, 49 clinical trials were carried out, and more than 30 patents were filed through the support of the US National Cancer Institute (NCI). These datasets are critical as a means to identify how molecular information affects clinical outcomes.”

Biobanking 104

Biobanking Clinical Trials Clinical Trials Trials 104

pharmaphorum

DECEMBER 2, 2020

The FDA had already granted fast-track designation to the combination therapy, allowing extra help during the development process on the basis of earlier clinical data. The trial continued enrolment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil.

Drugs 52

Drugs Trials Antibody Marketing 52

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 130

Clinical Trials Clinical Trials Trials Development 130

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. Pfizer provided feedback.

Trials 228

Trials Medicine Research Clinical Trials 228

Pharmaceutical Technology

NOVEMBER 30, 2022

“Bariatric surgeries show 30% weight loss in the first year and 25% weight loss in the long term,” says Papamargaritis, while that the clinical data for Mounjaro shows that the drug leads to a 16–22.5% One highly anticipated study is Mounjaro’s SURMOUNT-MMO Phase III clinical trial. billion in 2022 alone to expand capacity.

Drugs 264

Drugs Manufacturing Hormones Contract Manufacturing 264

Pharmaceutical Technology

NOVEMBER 30, 2022

“Bariatric surgeries show 30% weight loss in the first year and 25% weight loss in the long term,” says Papamargaritis, while that the clinical data for Mounjaro shows that the drug leads to a 16–22.5% One highly anticipated study is Mounjaro’s SURMOUNT-MMO Phase III clinical trial. billion in 2022 alone to expand capacity.

Drugs 246

Drugs Manufacturing Hormones Contract Manufacturing 246