Rethinking Clinical Trials

DECEMBER 14, 2022

Ethics, Stepped Wedge Cluster Randomized Trial, Study Design. If a cluster randomized trial is justified there are different types of CRT designs, the parallel arm CRT, parallel arm before and after CRT, cluster cross-over, and stepped wedge. – Could stepped wedge be a good design for implementation trials? Key Points.

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Roots Analysis

MARCH 8, 2023

It is worth noting that smart labels contain a transponder code which can be read by sophisticated devices, including radio frequency identification device (RFID) tags and near-field communication (NFC) chips. While most smartphones can read NFC chips, RFID tags can only be read by specialized receivers.

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pharmaphorum

DECEMBER 24, 2021

Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track designation to lecanemab, their follow-up to recently approved Aduhelm.

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Rethinking Clinical Trials

JULY 9, 2023

Clinical research can exacerbate disparities, because clinical trials typically are based in urban, academic medical centers, underrepresent diverse populations, and overlook community engagement strategies in trial planning and design. Implementation mapping at the beginning of the design process is key.

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Rethinking Clinical Trials

MAY 19, 2023

The team’s goals were to design for the primary care setting because 85% of hypertension care is in this setting. The team wanted the visualization designed for shared decision making, with an emphasis on patient information needs and comprehension and physician information needs and workflow.

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Rethinking Clinical Trials

JANUARY 31, 2024

The first step is to develop measures of success, the second step is designing the workflow, and the third step is evaluating pre-integration safety and effectiveness before a solution is put into clinical use. The next key decision point is clinical integration. . How do you mitigate bias because of incomplete data?

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Pharmaceutical Technology

DECEMBER 5, 2022

The two types of cannabinoids targeting cannabinoid receptors are endocannabinoids, which are naturally occurring endogenous ligands and synthetic cannabinoids, which are designed in a laboratory. Cannabinoid-based drugs are derived from compounds found in the cannabis plant. This is closely followed by CB2 receptors in second place.

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Rethinking Clinical Trials

AUGUST 28, 2023

The rapidly evolving ecosystem now relies on real-world data, which is becoming increasingly more advanced, and clinical trial design is becoming more complex and innovative. The E6 Good Clinical Practice clinical trial conduct principles was intended to be an improvement of the G8 clinical trial design principles.

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Rethinking Clinical Trials

AUGUST 28, 2023

The rapidly evolving ecosystem now relies on real-world data, which is becoming increasingly more advanced, and clinical trial design is becoming more complex and innovative. The E6 Good Clinical Practice clinical trial conduct principles was intended to be an improvement of the G8 clinical trial design principles.

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Intouch Solutions

JUNE 27, 2023

GA4 is a new property designed for the future of measurement: Collects both website and app data to better understand the customer journey. 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.

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Pharmaceutical Technology

JANUARY 17, 2023

Despite its high price tag, bimagrumab’s unique features set it apart from currently marketed therapies. Mounjaro is anticipated to launch in the US later this year or by early 2024. Bimagrumab is an activin receptor type 2B (ACVR2B or EC 2.7.11.30) antagonist that offers a unique mechanism of action within the obesity market.

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Roots Analysis

MARCH 1, 2024

Examples of technologies used in providing overt security features include holograms, colour shift inks / films, security graphics (special graphics included on the packing that are visible to the naked eye) and on-product markings (markings of logos or other designs done on tablets and capsules).

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Rethinking Clinical Trials

FEBRUARY 14, 2024

It had a pragmatic recruitment model with an embedded design, multicenter study without local study investigators and management teams, and broad recruitment that included patients from all 50 states and Puerto Rico. Both drugs have a well-established safety profile and would be a good fit for a pragmatic design.

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Rethinking Clinical Trials

FEBRUARY 13, 2023

The design of platform trials can build on the lessons learned from this study. – Why didn’t you start to design the follow-on trial while you were still in the field? Our study gave us a unique power to understand what happens after newborn cardiac surgeries. COVID-19 absorbed everyone in the middle of the trial.

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Rethinking Clinical Trials

JUNE 29, 2022

Real-world evidence (RWE) is clinical evidence derived from analysis of RWD regardless of study design. Real-world data (RWD) is a term with specific regulatory implications referring to health care data routinely collected from a variety of sources. A thoughtful approach that considers the characteristics that matter is the best approach.

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pharmaphorum

APRIL 27, 2022

AstraZeneca and Daiichi Sankyo have claimed a fifth breakthrough designation from the FDA for Enhertu, shortly after showing the drug extended survival in patients with HER2-low metastatic breast cancer. Drugs given the designation are hastened through the development process by the FDA, which can grant them a faster six-month review.

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The Pharma Data

FEBRUARY 22, 2022

As part of its on-going work to track variants, WHO’s Technical Advisory Group on SARS-CoV-2 Virus Evolution ( TAG-VE ) met yesterday to discuss the latest evidence on the Omicron variant of concern, including its sublineages BA.1 At a global level, the proportion of reported sequences designated BA.2 2 (or Nextstrain clade 21L).

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Rethinking Clinical Trials

SEPTEMBER 28, 2023

In areas of quality improvement people often do not consider cluster randomized design or people may be disappointed if they are randomized to usual care. For example, one local clinic did not have the room space, so the coaches called the family the day before then they could pop in quickly for a brief discussion.

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Rethinking Clinical Trials

JANUARY 17, 2024

Tags #pctGR, @Collaboratory1 The post Grand Rounds January 12, 2024: Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce Covid-19 Resources (Erin K. Many patients did not answer the phone. There were also patients who wanted to talk to their doctor, and they needed time to pull in their provider.

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pharmaphorum

AUGUST 25, 2022

Talquetamab has also shown promise in myeloma in the phase 1 MonumenTAL-1 study, which showed a 70% overall response rate (ORR) with the drug, and claimed a breakthrough designation from the FDA in June. Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

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Rethinking Clinical Trials

AUGUST 10, 2023

“Serious games” are games designed for a purpose beyond pure entertainment. They use motivation, game design, competition, curiosity, collaboration, challenges, media, and learning to accomplish something. Tags #pctGR, @Collaboratory1 The post Grand Rounds August 4, 2023: AI & ML: Want to Play a Game?

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The Pharma Data

NOVEMBER 29, 2021

On 26 November 2021, WHO designated the variant B.1.1.529 1.1.529 a variant of concern, named Omicron, on the advice of WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). WHO will continue to provide updates as more information becomes available, including following meetings of the TAG-VE. Source link: [link].

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Rethinking Clinical Trials

MAY 25, 2023

The pragmatic randomized control trial was designed from a hospital policy perspective. 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.

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Drug Discovery World

NOVEMBER 7, 2022

CELMoDs are designed to attack cancer by binding to a regulatory protein called cereblon, which then triggers the degradation of key cancer-driving proteins. . The finding will enable researchers to reliably design effective CELMoDs. . Understanding the problem.

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Rethinking Clinical Trials

JANUARY 26, 2023

EVOLVE-MI has trial design and infrastructure innovations, including automated data collection and leveraging Swedish registries. Tags #pctGR, @Collaboratory1 The post Grand Rounds January 20, 2023: Collaborative Pragmatic Trials in Action: EVOLVE-MI (Mikhail Kosiborod, MD) appeared first on Rethinking Clinical Trials.

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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.

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pharmaphorum

AUGUST 21, 2022

In this product, bupropion is designed to increase levels of dextromethorphan in the blood and extend its half-life. Axsome’s drug was given a breakthrough designation from the FDA, reflecting the need for new treatment options in patients at increased risk of self harm or suicide, and was also given a priority review.

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Rethinking Clinical Trials

OCTOBER 27, 2022

Having a tech person on the study design team to advise on which devices are secure will allow as many people as possible to participate. You need to involve them from the design phase. There are doable ways to increase cybersecurity in health care. Learn more. Discussion Themes. What is the path forward? pctGR, @Collaboratory1.

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Rethinking Clinical Trials

AUGUST 3, 2023

Design stand-alone data visualizations because one thing that happens in a social media world is that the graphs and visualizations very quickly escape their containers. Tags #pctGR, @Collaboratory1 The post Grand Rounds July 28, 2023: How Can Researchers Fight Misinformation About Medicine? We need to find a way to tackle this.

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Rethinking Clinical Trials

FEBRUARY 28, 2024

It is based on good study design and focusing on the key principles we are trying to adhere to. Tags #pctGR, @Collaboratory1 The post Grand Rounds February 23, 2024: Virtual Vigilance: Monitoring of Decentralized Clinical Trials (Adrian Hernandez, MD; Christopher J. I think we must.

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Rethinking Clinical Trials

AUGUST 18, 2022

These terms and designations were intended to restrict rights. Study design and approach should support diversity goals. People are “underrepresented” because they have been historically excluded and marginalized. How we categorize race and ethnicity in the U.S. has been historically about oppression. Passitonstudy.org/results.

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XTalks

APRIL 18, 2024

Roche has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Elecsys pTau217 early Alzheimer’s blood test. The Elecsys pTau217 assay is designed to detect amyloid pathology, a hallmark of Alzheimer’s disease, by measuring phosphorylated tau protein in human plasma.

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The Pharma Data

MARCH 7, 2022

By combining CRISPR technology with a protein designed with artificial intelligence (AI), it is possible to awaken individual dormant genes by disabling the chemical “off switches” that silence them. Ruohola-Baker and Levy then fused this designed protein with a disabled version of a protein called Cas9. 2022 Mar 1;38(9):110457.

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Rethinking Clinical Trials

FEBRUARY 9, 2023

It was important to observe behaviors in real time and be open to making changes at multiple points during the design and testing process. The trial was designed before the COVID-19 pandemic, but it was conducted during the height of the pandemic in New York.

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Pharmaceutical Technology

APRIL 13, 2023

Although the findings in the report are only preliminary, they shed light at the considerations behind the high price tags of gene therapies. However, Vertex and CRISPR’s exa-cel is designed to remove a part of the patient’s BC11A gene to increase foetal haemoglobin levels in red blood cells, using CRISPR editing.

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Rethinking Clinical Trials

OCTOBER 13, 2022

What I learned from designing this trial is that you can never plan that centers will recruit the same amount of patients as we would do in the initiating center. We had to the change the protocol once to correct a wording mistake. You have to include more centers to reach your goal during the course of the study. pctGR, @Collaboratory1.

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Drug Discovery World

JANUARY 9, 2023

The engineered tumour cells were also designed to express factors that would make it easy for the immune system to spot, tag, and remember them, priming the immune system for a long-term antitumour response. .

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