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.

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Rethinking Clinical Trials

NOVEMBER 21, 2023

The Nudge study wanted to find out if nudges could help patients improve medication adherence by promoting behavioral change through positive reinforcement. 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.

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Rethinking Clinical Trials

MARCH 6, 2024

The dietician met with the patient to share education about nutrition, portion size, recipes to make food taste good, and information via an optional diabetes self-management program. Recruitment was by phone calls and physician referrals, and consent was over the phone. They also screened for complications and close care gaps.

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Rethinking Clinical Trials

DECEMBER 14, 2022

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. Associate Dean for Research. Ethics, Stepped Wedge Cluster Randomized Trial, Study Design.

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Rethinking Clinical Trials

OCTOBER 13, 2022

The HandiCAP trial asked the question do intraoperative handovers of anesthesia care have an impact on patient outcomes? Patients were registered and randomized centrally in a 1:1 ratio to receive either a handover of anesthesia care or no handover. Are the results generalizable to all patient cohorts and to other health care systems?

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Rethinking Clinical Trials

AUGUST 22, 2022

Patients with diabetes or prediabetes were not excluded (except for those on insulin or sulfonylurea); pregnant patients were not excluded for the Metformin arm; the trial restricted participants to people who were overweight or obese to enrich the population for having a high risk of outcomes and for anti-inflammatory hypotheses around Metformin.

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Rethinking Clinical Trials

FEBRUARY 28, 2024

Outcomes including patient reported outcomes, functional assessments including via digital technology, healthcare events or mortality may require identify verification. Tags #pctGR, @Collaboratory1 The post Grand Rounds February 23, 2024: Virtual Vigilance: Monitoring of Decentralized Clinical Trials (Adrian Hernandez, MD; Christopher J.

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Rethinking Clinical Trials

SEPTEMBER 22, 2022

The Danish Nationwide Registries include the Danish Patient Registry (a registry of every inpatient and outpatient contact in the Danish free-for-all public healthcare system); the Danish Medicines Registry (a registry of every filed prescription at any pharmacy in Denmark including information on pill strength, pack size, etc.); Key Points.

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Rethinking Clinical Trials

AUGUST 23, 2022

Participating organizations included FDA, NIH, academic institutions, pharmaceutical and device companies, patient advocacy groups, community groups, and data groups, and representatives from each organization had opportunity to extend invitation to others. It was held virtually on April 28-29, 2021. Learn more. pctGR, @Collaboratory1.

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Clinical Trials Clinical Trials Trials Medicine 130

pharmaphorum

JULY 25, 2022

J&J filed for approval of the bispecific in the US in December based on the results of the phase 1b MajesTEC-1 study in myeloma patients who had been treated with a median of five lines of prior therapy. Most patients diagnosed with myeloma will relapse over the course of their disease, so the disease is still considered incurable.

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Antibody Medicine Drugs Trials 52

Delveinsight

FEBRUARY 25, 2021

Quest runs 2,200 patient service centers and recruits 5,000 mobile phlebotomists who have experience and expertise in offering phlebotomy services for at-home visits. Working with Quest will help them support convenient access to blood collection for patients and healthcare providers.

DNA 52

DNA In-Vivo Genetics Medicine 52

XTalks

AUGUST 23, 2021

Dr. Weninger’s fellow panel members echoed that sentiment and sought to address some of the most pressing concerns around trial design, patient safety and data integrity in trials in this post-approval period for aducanumab. Now that [aducanumab] is approved, how will this affect clinical trials going forward?”.

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Clinical Trials Clinical Trials Trials Drugs 52

Rethinking Clinical Trials

FEBRUARY 22, 2023

The biggest change is that the patient now has a seat at the table. Providers must now earn the trust of relatively informed and knowledgeable patients through a two-way conversation. Patients were enrolled via an app in this virtual trial. We are empowering the patient and family, who have access to their data.

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Rethinking Clinical Trials

OCTOBER 19, 2022

These data increasingly include info that might signal physical, mental health or behavioral health risks to patient-subjects (e.g. What do patients and other stakeholders desire? extraction from health records and/or have treating clinicians or patients complete measures); and trials may operate under waivers of consent.

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Clinical Trials Clinical Trials Trials Medicine 130

Rethinking Clinical Trials

AUGUST 28, 2023

The American College of Physicians guideline states that “physicians and patients should treat acute, sub-acute and chronic LBP with non-drug therapies.” Patients in the usual care arm clinics are then scheduled to see a PCP. Presenters also shared challenges regarding scheduling and patient insurance coverage.

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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. Gene Therapy Approvals. Manufacturer: Ferring Pharmaceuticals A/S. Manufacturer: bluebird bio, Inc.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

pharmaphorum

OCTOBER 4, 2022

A key part of this initiative was the establishment of the Cancer Moonshot Biobank, which will ask cancer patients to donate biospecimens and associated health information to aid research. The objective is to gather patient biospecimens longitudinally to understand how patients react to treatments and how cancer develops over time.

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Biobanking Clinical Trials Clinical Trials Trials 95

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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Rethinking Clinical Trials

NOVEMBER 9, 2022

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. Like many trials during the COVID-19 pandemic, there were significant challenges and recruitment delays. The network ended up with 20 sites and 22 trialists.

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Rethinking Clinical Trials

OCTOBER 31, 2023

The Yale IRB and Trusted Medical helped facilitate the other states and anything we need to take in account for recruitment. Does it capture most what matters to patients? – How do you organize recruitment to ensure you have the diversity you want and how do you explain to people you are turning away?

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Pharmaceutical Technology

NOVEMBER 30, 2022

Previously, the standard of care for obesity consisted of holistic changes to diet, exercise, and bariatric surgery for eligible patients. However, despite the effectiveness of bariatric surgery, many obese patients are reluctant to undergo surgical procedures, opening the opportunity for a pharmaceutical approach. compared to a 5.1%

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Drugs Manufacturing Hormones Contract Manufacturing 264

Pharmaceutical Technology

NOVEMBER 30, 2022

Previously, the standard of care for obesity consisted of holistic changes to diet, exercise, and bariatric surgery for eligible patients. However, despite the effectiveness of bariatric surgery, many obese patients are reluctant to undergo surgical procedures, opening the opportunity for a pharmaceutical approach. compared to a 5.1%

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Drugs Manufacturing Hormones Contract Manufacturing 246