Rethinking Clinical Trials

OCTOBER 4, 2022

The Clinical Trial Transformation Initiative (CTTI) envisions an evidence generating system with trials that are patient-centered, integrated into health processes, quality, leverage all available data, and improve population health. We need to work together to find ways to evaluate the potential benefits and share lessons learned broadly.

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Rethinking Clinical Trials

JULY 6, 2023

Additional considerations are needed for the data management plan, monitoring plan, safety plan, task log, and case report forms in the FDA draft guidance. The DCT space is evolving and will require more commentary on guidance, sharing research, and effective implementation. Learn more Read more about Decentralized Clinical Trials.

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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. Additional data sources came from EHR data, health plan claims, and program participation data including food visits and education.

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Intouch Solutions

NOVEMBER 30, 2021

blue links) of the organic results appeared to be pulling from content outside of the HTML title tag at a much higher frequency. URLs Examined: 860 URLs across 50 websites were examined; only URLs with all available data points were part of this research. Specifically, title links (i.e., Our Methodology.

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Rethinking Clinical Trials

NOVEMBER 6, 2023

In IRGT trials, individuals are randomly assigned to arms, but treatment is delivered in groups or through shared intervention agents. In this trial, the researchers were interested in three main data structures. For nested models, the analytic model should match the expected structure of the data, and naïve models should not be used.

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Rethinking Clinical Trials

OCTOBER 27, 2022

Data Security, Disinformation, Cyberthreat. It was started when Andrea discovered a vulnerability in Facebook’s group platform that allowed data to be scraped outside of the group. The problem is patients can’t predict benefit or harm based on how their data is used. Chief Research Technology Strategist. Andrea Downing.

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XTalks

FEBRUARY 17, 2023

1) Add Social Sharing Buttons on Registration Pages Adding social sharing buttons to your registration page is a simple and straightforward way of spreading the word about your upcoming webinar. Doing this encourages people who are registering for your webinar to share the webinar page on their own networks.

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Rethinking Clinical Trials

FEBRUARY 22, 2023

The Heartline Trial has moved to a new form of information sharing, one that is open source, innovates from without, knowledge flows to and from all via the internet, people can share information, retaining credit for it but sharing it freely. We are empowering the patient and family, who have access to their data.

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XTalks

AUGUST 31, 2022

Hear more about the approval, including clinical trial data showing the treatment can take effect in as little as one week, and how it is the first antidepressant approved in over 60 years that has a new mechanism of action. Read the full articles here: Axsome’s Auvelity Wins FDA Approval as First Rapid-Acting Oral Treatment for Depression.

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The Pharma Data

NOVEMBER 29, 2021

1.1.529 a variant of concern, named Omicron, on the advice of WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). Researchers in South Africa and around the world are conducting studies to better understand many aspects of Omicron and will continue to share the findings of these studies as they become available.

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Rethinking Clinical Trials

OCTOBER 2, 2023

The PROTEUS Consortium’s objective is to ensure that patients, clinicians, and other decision-makers have high-quality PRO data from clinical trials and clinical practice to make the best decisions they can about treatment options. It collates and synthesizes foundational resources to create a unified, comprehensive resource.

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Rethinking Clinical Trials

JULY 27, 2022

It is a decentralized, fully remote trial, and data are largely patient reported. Results have been shared for the Ivermectin-400 and Fluticasone arms. ACTIV-6 is testing medication doses approved by the FDA for other purposes, i.e., repurposed drugs. ACTIV-6 is actively recruiting across 93 sites with 5,034 randomized.

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XTalks

FEBRUARY 8, 2024

Along with the hefty price tag for screen time that may not be perceived to be a worthwhile investment, and despite favoring advertising at other major events like the Grammys, pharma tends to stay somewhat clear of all the Super Bowl hoopla. Bayer is preparing to file for FDA approval based on strong Phase III data it shared last month.

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pharmaphorum

JANUARY 24, 2022

A private equity group has agreed to take over most of IBM Watson Health, seven years after the business was launched with a pledge to revolutionise healthcare data analysis. For its part, IBM has said that the Watson for Oncology product has been improving year-on-year as the AI crunches more and more data.

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Cloudbyz

JUNE 1, 2023

Record Triggers: Flow can respond to changes in Salesforce data, initiating processes when records are created or updated. They’re typically initiated by a change in record data. Integration: Salesforce Flow can integrate with external systems through callouts, giving it the ability to interact with data outside of Salesforce.

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Cloudbyz

JUNE 2, 2020

As a Salesforce admin, you can share this trick with your entire user base. Create a folder called ‘Dynamic Reports’ Share the folder to users who should access these reports. Salesforce uses these UI tags: fv0 , fv1 , fv2 for custom filters added after standard filters in URLs to run the report. Let’s decode the magic!

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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. Sickle cell disease is an inherited blood disorder that is caused by mutations in the HBB gene, which codes for the oxygen-carrying protein haemoglobin in red blood cells.

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XTalks

MAY 2, 2024

Networking sessions throughout both days allowed participants to discuss industry trends and share experiences, further enriching the collaborative atmosphere of the summit. Katie Jantti, Strategic Account Manager at TraceGains , mentioned the use of AI in data automation, traceability and laboratory testing. “We’re

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pharmaphorum

AUGUST 17, 2020

In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. Virtual connections. Content consistency. Is there legacy branding? Personalising marketing content.

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Rethinking Clinical Trials

NOVEMBER 21, 2022

The team was also able to generate some pilot data on outcomes such as reintubation rate and length of respiratory support to try and understand how we could take this forward in a trial. Many other trials in the country were behind and everyone else had to stop. pctGR, @Collaboratory1.

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Rethinking Clinical Trials

AUGUST 28, 2023

There is also a longitudinal cohort of EHR data for all patients at participating PCP clinics to assess utilization and other broad outcomes. Presenters also shared challenges regarding scheduling and patient insurance coverage.

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Rethinking Clinical Trials

NOVEMBER 21, 2023

There was also an option to complete a survey to share reasons for opting out. Nudge used an opt out approach, with IRB approval because it was a low-risk intervention and having patients consent on a large scale would be challenging and might bias the sample to more adherent patients. The study would then recalculate the gaps.

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pharmaphorum

MARCH 23, 2022

Vyvgart (efgartigimod alfa) became the first drug in the FcRn class to be approved by the FDA last December, and despite a $225,000 annual price tag is predicted to make relatively modest sales in its IV version, which will compete with other IV gMG drugs like AstraZeneca/Alexion’s C5 inhibitor Soliris (eculizumab).

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pharmaphorum

NOVEMBER 27, 2022

Empowering labs with automated equipment that produces rich, traceable, and actionable data insights means pharmaceutical companies can ensure drug production runs smoothly – even under stress. Better communication with traceable data. Automation can be such a solution. Automation will be a large part of this long-term vision.

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Pharmaceutical Technology

MARCH 22, 2023

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Twenty years ago, the cost of implementing RFID tags and the ecosystem (software) was much more expensive than today.

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pharmaphorum

AUGUST 28, 2020

The world is awash with data, and while retailers and TV subscription services have perfected the art of collection and curation, public health has been trailing behind. Data inadequacies. At this moment, people recognise that monitoring infectious diseases, in the US or globally, is challenging because data takes time.

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XTalks

AUGUST 19, 2022

Zynteglo’s hefty price tag of $2.8 Zynteglo’s approval was based on data from bluebird bio’s Phase III studies HGB-207 (Northstar-2) and HGB-212 (Northstar-3), and the long-term follow-up study LTF-303. Bluebird’s announcement of the FDA approval for Zynteglo led bluebird bio’s shares to jump seven percent this week.

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XTalks

NOVEMBER 10, 2020

IoT uses a combination of mechanical and digital devices, including sensors and IP addresses, to transfer data over a network without the need for human intervention. Inherent risks can be minimized by: Allowing information to be shared with various stakeholders across global supply chains.

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pharmaphorum

JANUARY 11, 2021

While bluebird has conducted pioneering work in gene therapy for blood disorders and in cancer cell therapy, products have been delayed by issues with filing data for the FDA. million price tag. Zynteglo is already in beta-thalassemia in Europe, where the company will seek to expand access despite its hefty $1.8

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pharmaphorum

JUNE 12, 2022

bluebird bio started last week on tenterhooks, as FDA advisors cast their eyes over data for two gene therapy candidates that are key to its future as a commercially viable concern. Beti-cel has already been approved for marketing in Europe as Zynteglo, with a price tag of around $1.8

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Drug Discovery World

JANUARY 30, 2024

Better, more intentional data and forums for cross-functional knowledge building across sectors are the best opportunities to increase price transparency, pace to market, and ultimately, access to therapies for patients.” Fostering open innovation and collaboration could help address this issue.

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XTalks

DECEMBER 13, 2023

The revolutionary CRISPR/Cas9 technology was discovered by Jennifer Doudna and CRISPR Therapeutics co-founder Emmanuelle Charpentier who both shared the 2020 Nobel Prize for it. Data on the long-term effects of the therapies is limited, as trials evaluating the therapies were only two years long.

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Intouch Solutions

AUGUST 25, 2021

Updates to the Apple Mail app will allow users to change their privacy settings and allow Apple to hide their data in emails. There has been exponential growth in user concerns in recent years and, as a result, companies are addressing these concerns and becoming increasingly transparent about how they use consumer data.

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XTalks

FEBRUARY 27, 2024

Despite high price tags of a couple of million dollars, gene therapy makers say they are working to ensure patients are able to access the treatments through patient assistance programs developed in conjunction with the support of governments. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.

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Pharmaceutical Technology

APRIL 5, 2023

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. By Cytiva Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

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XTalks

DECEMBER 21, 2022

The multi-million-dollar price tags are largely attributable to the high R&D and manufacturing costs associated with making a gene therapy, as the raw materials for producing the therapy can be expensive. Virtual trial processes involve the use of technologies that enable remote data collection and sharing. AI/ML Technology.

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XTalks

NOVEMBER 27, 2021

The technical advisory group on SARS-CoV-2 virus evolution (TAG-VE) met on Friday to discuss B.1.1.529, Shortly after, researchers in Botswana and Hong Kong also publicly shared sequences of the variant where it has also been found. percent to be exact), according to the Our World in Data COVID-19 vaccine tracker.

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