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.

Medicine 52

Medicine Production Manufacturing Containment 52

Rethinking Clinical Trials

FEBRUARY 28, 2024

But there are concerns to developing DCTs including lack of standardization and validation, regulatory and ethical uncertainties, engagement vs. coercion, data security and privacy issues, technological literacy and access, resistance to change and adoption, and lack of “safe” sharing. from 2021 to 2026.

Clinical Trials 141

Clinical Trials Clinical Trials Trials Clinical Research 141

Pharmaceutical Technology

MAY 1, 2023

CTH-004 is developed by genetically altering patient T cells for inserting a chimeric antigen receptor (CAR) to target a marker (TAG-72) on ovarian cancer cells and delete genes which are involved in T cell function suppression. Additionally, both the companies will share CTH-004 pre-clinical and clinical data in future.

Gene Therapy 130

Gene Therapy Gene Development Clinical Trials 130

Rethinking Clinical Trials

OCTOBER 26, 2023

There is a lack of point-of-care diagnostics; it can take up to 3 steps to treatment initiation. point of care diagnostic tests, provide broad access to curative Hepatitis C medications with a national subscription model, with Medicare co-pay assistance and commercial insurance coverage. The initiative would bring to the U.S.

Clinical Research 141

Clinical Research Clinical Trials Clinical Trials Research 141

Rethinking Clinical Trials

MAY 19, 2023

Colwill Professor and Vice Chair Department of Family and Community Medicine University of Missouri Slides Keywords Electronic Health Record, Pragmatic Clinical Trial Key Points Patients bring patient-generated home blood pressure data into the clinical workflow. It was data that was sitting there without alerts in our system.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

DECEMBER 20, 2023

It is important to note when you look at the ARIC surveillance data, there is consistently higher risk in black females and males across all ages. This is a really important point because we know that providers have bias, and it is the providers who do not approach women for enrollment. There are also ethnic and racial disparities.

Clinical Trials 169

Clinical Trials Clinical Trials Trials Cardiology 169

Rethinking Clinical Trials

JANUARY 26, 2023

This study is looking at a particular subpopulation, where there is a lack of outcomes data. EVOLVE-MI has trial design and infrastructure innovations, including automated data collection and leveraging Swedish registries. – Could you talk a little bit more about hybrid data collection?

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

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. Considerations.

Branding 52

Branding Engineer Research Marketing 52

Rethinking Clinical Trials

APRIL 18, 2023

RECOVER has used cohort data to identify major symptom clusters and develop 5 platform protocols that will investigator priority symptom clusters and their causes; test known and novel interventions across domains; and evaluate treatments to improve Long COVID symptoms. No, there are no signs PASC is going away.

Clinical Trials 219

Clinical Trials Clinical Trials Trials Immune Response 219

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

Clinical Trials 141

Clinical Trials Clinical Trials Medicine Trials 141

Rethinking Clinical Trials

MAY 10, 2023

Denny, MD, MS CEO, All of Us Research Program Slides Keywords Precision Medicine, All of Us Research Program Key Points The mission of the All of Us Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us. We are looking forward to supporting more.

Medicine 130

Medicine Research Clinical Trials Clinical Trials 130

Rethinking Clinical Trials

SEPTEMBER 28, 2023

In the PCORI funded trial we are doing stepped wedge so everyone gets the intervention at some point, which was important to our partners. Our partners want to know the data and what it takes to collect it in a rigorous way. Our partners want to know the data and what it takes to collect it in a rigorous way.

Trials 269

Trials Clinical Trials Clinical Trials Research 269

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. – Are there any concerns that the pragmatic nature could reduce the chance of showing a benefit?

Clinical Trials 130

Clinical Trials Clinical Trials Trials Packaging 130

Rethinking Clinical Trials

MARCH 15, 2023

The difference relates to how data is weighed. – It’s difficult to determine definitively if there is informative cluster size, but it would be interesting to evaluate in pilot data clusters. and “How much would standard errors really change?” Two estimands will differ when there is informative cluster size in a trial.

Trials 130

Trials Clinical Trials Clinical Trials Research 130

Rethinking Clinical Trials

OCTOBER 11, 2023

Moyer, PhD Statistician, NIH Office of Disease Prevention Slides Keywords Implementation; Study design; Hybrid; Clustered; DECIPHeR Key Points People often contest that hybrid designs are not as rigorous as they should be. Second, you shouldn’t tell the staff collecting the outcome data which arm the various sites are in.

Clinical Trials 152

Clinical Trials Clinical Trials Trials Research 152

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.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Rethinking Clinical Trials

OCTOBER 4, 2022

Key Points. 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. Tech support at the site level is important to addressing problems in a study.

Trials 130

Trials Clinical Trials Clinical Trials Production 130

Rethinking Clinical Trials

AUGUST 10, 2023

” The key to quality of AI and utilizing AI in a beneficial way relates to the quality of the data. ” The key to quality of AI and utilizing AI in a beneficial way relates to the quality of the data. The key is to have a deep understanding and control over the data being used.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Medicine 130

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. Interstate licensing and our own institution’s policies are issues that still need to be addressed in terms of oversight and responsibilities.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

Rethinking Clinical Trials

AUGUST 3, 2023

Bergstrom, PhD Professor, Department of Biology University of Washington Slides Keywords Research, Misinformation, Media, Social Media Key Points Misinformation abounds in medicine and about medicine. The data of what is happening with social media is not available unless you are collaborating with social media.    Speaker Carl T.

Medicine 130

Medicine Research Vaccination Vaccine 130

Rethinking Clinical Trials

JANUARY 17, 2024

UPMC set clear criteria based on the published data at the time for who could and could not receive Remdesivir. All eligible patients were gathered from data warehouse and manual EHR entry. The first drug that used the new process was Remdesivir in May 2020. We know there is a digital gap in disadvantaged patients and elderly patients.

Clinical Trials 169

Clinical Trials Clinical Trials Antibody Trials 169

World of DTC Marketing

JUNE 23, 2021

39 points on an 18-point scale that measures cognitive ability. The finding was far lower than the one to two points generally considered to be statistically significant improvement. Not to mention the $56,000 annual price tag.

Drugs 218

Drugs FDA Approval Doctors Doctor 218

Rethinking Clinical Trials

JULY 22, 2022

Key Points. Candidate agents were triaged based on concurrent clinical trials, completion of a multiple ascending dose study, and availability of preclinical data before being scored based on predefined criteria. ? ? ? ? ? ? ? ? ? ? ? ?. Speaker. Associate Vice President, Research Partnerships. Foundation for the NIH.

Vaccination 130

Vaccination Vaccine Clinical Trials Clinical Trials 130

Pharmaceutical Technology

APRIL 13, 2023

Two gene therapies up for approval this year for sickle cell disease could be cost effective in some cases at a $2 million price point, based on a draft evidence report published by the Institute for Clinical and Economic Review (ICER). Topic sponsors are not involved in the creation of editorial content.

Gene Therapy 147

Gene Therapy Gene FDA Approval Licensing 147

Rethinking Clinical Trials

AUGUST 30, 2023

   Speaker Gabriela Schmajuk, MD, MS Professor of Medicine UCSF and the San Francisco VA Slides Keywords Patient-Reported Outcomes, Rheumatoid Arthritis, EHR Key Points Clinicians rely on patient-related outcomes (PROs) to track disease and function over time in patients with rheumatoid arthritis (RA).

Trials 141

Trials Clinical Research Coordinator Medicine Clinical Trials 141

Rethinking Clinical Trials

OCTOBER 27, 2022

Data Security, Disinformation, Cyberthreat. Key Points. 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.

Clinical Research 130

Clinical Research Research Clinical Trials Clinical Trials 130

Rethinking Clinical Trials

MAY 25, 2023

Therefore, it can be considered an acceptable option when clinicians, patients and hospital consider these data. While people may be interested in specific subpopulations or outcomes, the confidence interval is not adjusted for multiple comparisons, so slicing the data could risk spurious findings.

Trials 130

Trials Clinical Trials Clinical Trials Compliance 130

World of DTC Marketing

SEPTEMBER 9, 2021

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. However, experiences among individual hospitals vary, and about one-quarter of both for-profit and not-for-profit hospitals lost money in 2016.

Drugs 222

Drugs Pharmacy Clinical Trials Clinical Trials 222

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. In doing this, they were able to replicate the data among different populations. The team also engaged with a diverse array of providers from multiple hospitals and specialties.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

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.

Clinical Trials 152

Clinical Trials Clinical Trials Research Trials 152

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

Regulation 97

Regulation Marketing Sales Branding 97

Rethinking Clinical Trials

JULY 27, 2022

Key Points. It is a decentralized, fully remote trial, and data are largely patient reported. Professor of Medicine. Vice Dean for Clinical Research. Duke University School of Medicine. ACTIV, ACTIV-6, COVID-19, Ivermectin, Inhaled Fluticasone. Were there concerns about having patients not associated with a site?

Trials 169

Trials Pharmacy Medicine Clinical Trials 169

Rethinking Clinical Trials

SEPTEMBER 13, 2023

After enrolling patients for 8 months, the data safety board recommended trial enrollment stop because the prespecified stopping criteria for efficacy had been met. When the procedure is performed in the Operating Room complications are rare (2%); when performed in the Emergency Department and ICU complications are more common (40%).

Trials 141

Trials Clinical Trials Clinical Trials Medicine 141

Rethinking Clinical Trials

FEBRUARY 16, 2023

The study used a patient-information sheet to inform patients about the research, how patient data would be handled, and an option to opt-out of including their data in the study. Tags #pctGR, @Collaboratory1 The post Grand Rounds Ethics and Regulatory Series February 10, 2023: Informing and Consenting: What Are the Goals? (P.

Clinical Trials 130

Clinical Trials Clinical Trials Medicine Trials 130

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.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

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.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Rethinking Clinical Trials

DECEMBER 12, 2023

For the Jumpstart trial, a number of refinements were made to make it more pragmatic, including the creation of Jumpstart using EHR data rather than patient or family member surveys, delivering the intervention to clinicians only, automated population of Jumpstart guide fields, and automated Jumpstart delivery to clinicians by email.

Trials 130

Trials Medicine Clinical Trials Clinical Trials 130