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). EVOLVE-MI has trial innovation through its Academic Research Organizations (AROs), who are also enrolling and understand challenges firsthand. EVOLVE-MI is enrolling 4,000 patients in 3 countries.

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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. The biggest inflection point for CardioNerds was COVID-era recruitment, when residents were asked to decide where to train for fellowship without having in-person visits. Key Points.

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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. ? ? ? ? ? ? ? ?. Speakers.

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Rethinking Clinical Trials

JULY 27, 2022

It is a decentralized, fully remote trial, and data are largely patient reported. ACTIV-6 is actively recruiting across 93 sites with 5,034 randomized. It turned out that Ivermectin turned out to be a good recruitment tool. There was a lot of outreach to sites and they embraced the remote trial. Learn more about ACTIV-6.

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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.

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Rethinking Clinical Trials

DECEMBER 14, 2022

Ethics, Stepped Wedge Cluster Randomized Trial, Study Design. There are two main types of clinical trials: patient randomized trial and cluster randomized trial (CRT). If stepped wedge design is the best option, you have to ensure that the analysis is robust and sound and that there is not recruitment bias.

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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, Recruitment was by phone calls and physician referrals, and consent was over the phone.

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Rethinking Clinical Trials

FEBRUARY 28, 2024

The global decentralized clinical trial market is expected to grow at a compound annual growth rate of 30.1% There is agreement that trials need to meet the people, at home and covering clinical trial deserts. Regardless of the trial inclusion and exclusion is routine. from 2021 to 2026. I think we must.

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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.

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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.

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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.

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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. Learn more.

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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?

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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. Key Points.

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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. Ethics, IRB, FM-TIPS.

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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).

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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.

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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.

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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. Discussion Themes -Do you think the results support a text message nudge in most clinical trials and what is the cost effectiveness of this?

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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.

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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. While not anticipated, it was also necessary to have dedicated research staff to ensure adequate recruitment. – Do you think that this intervention is sustainable?

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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.

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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.

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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?”.

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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.

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pharmaphorum

NOVEMBER 19, 2021

Disappointing late-stage trials of CureVac’s jab meant there was no competitive advantage, while Sanofi said the dominance of current vaccines made penetration in the market difficult. Indeed, the price tags for Pfizer’s and Moderna’s jabs are substantial. Pfizer is understood to have charged $19.50 per dose in the US and €19.50

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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). Informed consent is crucial to recruiting the patient to the study.

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pharmaphorum

DECEMBER 2, 2020

Aside from Gazyvaro, CLL can be treated with older chemotherapy agents, or Roche/AbbVie’s Venclexta (venetoclax) in some instances, and the fast track tag showed the FDA considered the combination to be a promising new contender on the market. TG said it expects the data submission to be complete in the first half of 2021.

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Pharmaceutical Technology

NOVEMBER 30, 2022

The company’s weight loss drug Saxenda (liraglutide) won an approval for chronic weight management in December 2014, and Wegovy (semaglude) got the same tag in 2021. One highly anticipated study is Mounjaro’s SURMOUNT-MMO Phase III clinical trial. Novo Nordisk is another company leading the charge in this field. compared to a 5.1%

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Pharmaceutical Technology

NOVEMBER 30, 2022

The company’s weight loss drug Saxenda (liraglutide) won an approval for chronic weight management in December 2014, and Wegovy (semaglude) got the same tag in 2021. One highly anticipated study is Mounjaro’s SURMOUNT-MMO Phase III clinical trial. Novo Nordisk is another company leading the charge in this field. compared to a 5.1%

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