Rethinking Clinical Trials

OCTOBER 27, 2022

Co-Founder – The Light Collective. Data Security, Disinformation, Cyberthreat. The Light Collective is an organization that represents collective rights, interests, and voices of patient communities in healthcare technology. The problem is patients can’t predict benefit or harm based on how their data is used.

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Rethinking Clinical Trials

MAY 10, 2023

Participants have access to their information, data will be access broadly for research purposes, and security and privacy will be of highest importance. All of Us has a philosophy to get data to researchers quickly. The Research Workbench data browser is available with no log in and you get aggregate results.

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Rethinking Clinical Trials

DECEMBER 6, 2023

There are several key design considerations for stepped-wedge design, including defining the estimand or what are you trying to estimate in the analysis, the key sources of variation, and how outcome data will be collected. How will the treatment effect the outcome? Magnitude of effect is a key power consideration.

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Rethinking Clinical Trials

AUGUST 18, 2022

There is plenty of data that shows that. We have a long way to go; we are talking about data we don’t currently collect. In January we will be expected to collect data on social needs. How will that be collected? The social circumstances affect health outcomes. These social factors can result in changes. -How

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Rethinking Clinical Trials

MARCH 28, 2023

Data are drawn from millions of EHRs with growing links to patient-reported and payor data. It is one of the only data resources with granular clinical data, lab data, and very large sample sizes. We have significantly improved the process of working with sites to collect and refine the data over time.

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World of DTC Marketing

SEPTEMBER 9, 2021

Collectively, hospitals boast a margin of 8 percent, a level higher than margins in the pharmacy industry or the insurance industry. A study put a price tag on American’s bad eating habits: $50 billion a year in health care costs, attributable to cardiometabolic diseases such as heart disease, stroke, and type 2 diabetes.

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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. With current funding, PROTEUS can address recommendations specifically regarding education materials.

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Rethinking Clinical Trials

MARCH 1, 2023

To reduce the burden on sites, the study has simplified data reporting by reducing time points data, reducing the number of forms that need to be submitted, and reducing the number of data elements within a form. The study does not include tissue specimen collection, image submission, or patient-reported outcome instruments.

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Rethinking Clinical Trials

SEPTEMBER 28, 2023

Our partners want to know the data and what it takes to collect it in a rigorous way. Tags #pctGR, @Collaboratory1 The post Grand Rounds September 22, 2023: Integrating Community Health Workers into Team-Based, Early Childhood Preventative Care (Tumaini Rucker Coker, MD, MBA) appeared first on Rethinking Clinical Trials.

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Rethinking Clinical Trials

OCTOBER 11, 2023

Second, you shouldn’t tell the staff collecting the outcome data which arm the various sites are in. To the extent that you can use data from electronic health records, that will help with keeping the staff blinded. It’s important to note that it’s more difficult to keep the centers, or actual clusters, blinded.

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Roots Analysis

JANUARY 28, 2024

Big Data in healthcare refers to the vast amount of data that is continuously expanding and cannot be efficiently stored or processed using traditional tools. Within the healthcare sector, structured data includes demographic details, vital indicators (like, height, weight, blood pressure, blood glucose).

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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. Annex-2 of E6(R3) will include additional considerations of GCP principles focused on decentralized elements, pragmatic elements and real-world data sources.

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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. Annex-2 of E6(R3) will include additional considerations of GCP principles focused on decentralized elements, pragmatic elements and real-world data sources.

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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). WHO encourages countries to contribute the collection and sharing of hospitalized patient data through the WHO COVID-19 Clinical Data Platform to rapidly describe clinical characteristics and patient outcomes.

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Rethinking Clinical Trials

SEPTEMBER 22, 2022

Denmark also has registries tracking socioeconomic data such as income and level of education and other types of data that can be linked together for study. The DECODE trial used registry data to identify patients with chronic kidney disease. Learn more. Read about DANFLU-1. pctGR, @Collaboratory1.

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pharmaphorum

NOVEMBER 19, 2021

There are still uncertainties about Evrysdi, according to NICE, but it will be provided via the NHS on an interim basis while more data is collected. million price tag make it is the most expensive treatment ever approved for NHS funding.

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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. Is there legacy branding? How can we help consolidate all of that material?

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Delveinsight

JULY 22, 2020

The Internet of Things is the interconnection of available medical devices, software applications and other resources to collect and exchange data to provide a reliable, efficient, and smart healthcare service to the patients. Sensors/Devices are the primary data collection point in IoT. New Insight/Data For Research.

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Rethinking Clinical Trials

DECEMBER 6, 2022

After 3 months of active intervention, there was an additional 3 months of data collection. In the intervention group patients received 3 text messages weekly that were personalized encouraging them to be more active based on the past week’s activity. Sites have a lot of trials that are competing. One pays more than another.

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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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Medicine Research 71

XTalks

OCTOBER 12, 2022

MRI may also be used to evaluate drug dosing regimens, to gain insight about the mechanism of drug action, and to collect imaging biomarker data which could provide an earlier indication of response to therapy than clinical outcomes. Each patient is represented as one data point. Why Image Vascular Perfusion?

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pharmaphorum

DECEMBER 17, 2021

Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians have questioned the data on which the decision to clear the drug was based, plus a $56,000 per year price tag, which has in turn led to pushback by payers.

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XTalks

DECEMBER 13, 2023

bluebird expects cell collection for the first Lyfgenia patients to begin in the first quarter of 2024. Data on the long-term effects of the therapies is limited, as trials evaluating the therapies were only two years long. Vertex-CRISPR’s Casgevy has a US list price of $2.2 million and bluebird’s Lyfgenia is 40 percent higher at $3.1

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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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Drug Discovery World

JANUARY 30, 2024

While there are multiple methods to address these challenges such as increased automation, optimised cell lines, and downstream processing methods to name a few, it will be an iterative process to collectively address challenges. Increased clinical data and evidence of cost-effectiveness can improve coverage.

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The Pharma Data

OCTOBER 9, 2021

This designation is predicated on data showing that gantenerumab significantly reduced brain amyloid pillar, a pathological hallmark of Notice, in the ongoing SCarlet RoAD and Marguerite RoAD open- tag extension trials, as well as other studies. Roche’s Chief Medical Officer and Head of Global Product Development.

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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). These data increasingly include info that might signal physical, mental health or behavioral health risks to patient-subjects (e.g. Vanderbilt University Medical Center. Key Points.

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Rethinking Clinical Trials

FEBRUARY 2, 2023

There was a 1-page data collection sheet that trained site-specific observers completed with rapid feedback from research team on data quality. The data collector was not clinically taking care of the patient but familiar with the procedure and trained on data collection.

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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. There were also lessons learned regarding data collection, as many sites are not collecting and integrating PRO outcomes to a sufficient degree for the study.

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pharmaphorum

SEPTEMBER 30, 2022

This shift enables companies to improve the quality and compliance of the documents and data that make up regulatory submissions and create a data-sharing ecosystem that enhances healthcare. Most of the information is submitted in the form of unstructured PDF documents, with data embedded into them. Submission status quo.

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Pharmaceutical Technology

JANUARY 27, 2023

Hlávka explains that this approach makes sense with such a highly expensive drug for rare diseases, as the burden of collecting and recording individual patient outcomes is only possible when dealing with a smaller patient population. “It Also, the process to actually apply for reimbursement could be similarly difficult.

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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. Screen Flows: This feature allows the creation of interactive, guided screens that can be used to collect or display information to users. They’re typically initiated by a change in record data.

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Drug Discovery World

FEBRUARY 21, 2023

Ahead of his presentation in the Automation Technologies Track at SLAS2023, Pillai shares insight on data and how we can connect lab automation to decisions. He says the questions to ask are: “Data could be returned during a workflow for every single log returned from an instrument, but will that help you answer your question?

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pharmaphorum

OCTOBER 4, 2022

Central to the initiative is the aim to gather data from willing participants that can provide greater insights into cancer development and treatment over time. The Moonshot was started with three aims: to accelerate scientific discovery in cancer, foster greater collaboration between stakeholders, and to improve the sharing of cancer data.

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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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The Pharma Data

MAY 15, 2021

At the end of the day, this data is sent to various computers which give you a detailed report to look at. Check the time & date like a watch; connect and share data with Bluetooth; locate your smart device easily if lost or misplaced. Information The Company Collects. While this can be a great motivator for personal use….

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Drug Discovery World

OCTOBER 21, 2022

The main principle involves a well-defined light source such as that produced by lasers that excites fluorescent tags bound to the cells or particles present in a sample. Representative data for antibodies of interest from trusted manufacturers can also provide valuable information regarding fluorophore brightness and antigen expression. .

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