Scienmag

NOVEMBER 4, 2021

Persistent observations of large underwater animals are difficult to achieve without the help of electronic, multi-sensor tags. In particular, there has been little […].

Scientist 71

Scientist Engineer 71

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. The study randomized 13,523 patients across the U.S. from 72 VA healthcare systems.

Clinical Trials 154

Clinical Trials Clinical Trials Cardiology Trials 154

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. In this post, we will go over our SERP title analysis study, including the methodology, findings of our aggregate analysis, and recommendations on how best to move forward. Specifically, title links (i.e.,

Branding 52

Branding Engineer Research Marketing 52

pharmaphorum

DECEMBER 24, 2021

The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of early-stage Alzheimer’s disease. In a statement, Biogen and Eisai said that the FDA has agreed that Clarity AD “can serve as the confirmatory study to verify the clinical benefit of lecanemab.”

Drugs 111

Drugs FDA Approval Trials Marketing 111

Pharmaceutical Technology

JANUARY 17, 2023

On January 12, Versanis Bio announced that enrollment had begun for its Phase IIb trial, BELIEVE (NCT05616013), which aims to study bimagrumab’s (BYM-338) efficacy and safety in the US, among other locations. was observed in the study. Bimagrumab is of interest in the obesity space as it is a first-in-class therapy for obesity.

Development 130

Development Compliance Trials Marketing 130

STAT News

JULY 29, 2022

Among the small bunch of billionaires that the local biotech industry has created, Tim Springer may be the only one who regularly rides his bike to work in the Longwood Medical Area, where his ID tag identifies him simply as a “staff scientist.”

Scientist 98

Scientist Protein Research 98

Intouch Solutions

NOVEMBER 17, 2021

blue links) of the organic results appeared to be pulling from content outside of the HTML title tag at a much higher frequency. Title Tag – This is an HTML element that provides a title for the page. The title tag is not otherwise visible to users on the page. Specifically, title links (i.e., The SERP Title is the blue link.

Marketing 52

Marketing Engineer Branding 52

Pharmaceutical Technology

NOVEMBER 9, 2022

In August 2020, the agency had rejected an approval application, suggesting the company complete its Phase III Gener8-1 study and include two-year follow-up safety and efficacy data. million price tag. In the Gener8-1 Roctavian study , the modified intent-to-treat (mITT) population had a mean factor VIII activity of 42.8

Gene Therapy 278

Gene Therapy Gene FDA Approval Medicine 278

Scienmag

NOVEMBER 17, 2020

Credit: © Andreas Reicher / CeMM Until now, scientists typically studied the changes of proteins and their roles in the cell by using a fluorescent tag to label and follow one protein at a time. This approach limited the number of proteins that could be studied and precluded unbiased discovery approaches.

Protein 52

Protein Scientist Drugs Research 52

Rethinking Clinical Trials

OCTOBER 4, 2022

DCTs range from near-traditional to hybrid to fully remote trials that conduct study visits away from the central study site using strategies such as tele-visits or home delivery of investigational products. – A feasibility study is a good way to gain insight into possible snags when participants may not be tech savvy.

Trials 130

Trials Clinical Trials Clinical Trials Production 130

Sciensano

MAY 18, 2022

During this event, Dr. Tim Dallman (University of Utrecht) lectured on specific case studies, advantages and challenges of routine genomic surveillance of gastrointestinal pathogens. BE READY project coordinator, Transversal activities in Applied Genomics ( TAG )). Dr. Marie-Alice Fraiture ( TAG ). Dr. Kevin Vanneste ( TAG ).

Genome 52

Genome Genomics Research 52

STAT News

MARCH 10, 2023

 Two recent studies aimed to quantify how much R&D costs impact a drug’s price, and how much effectiveness correlates with its price — factors that might, in theory, help justify a sizable price tag. But neither factor has much effect, the studies concluded.

Insulin 96

Insulin Pharmacy Pharma Companies Drugs 96

Rethinking Clinical Trials

JUNE 29, 2022

Real-world evidence (RWE) is clinical evidence derived from analysis of RWD regardless of study design. With the 21st Century Cures Act of 2016, the FDA established a program to evaluate the potential use of real-world evidence to support new indications for drugs and satisfy post-approval study requirements. Discussion Themes.

Big Data 130

Big Data Clinical Trials Clinical Trials Drugs 130

Rethinking Clinical Trials

FEBRUARY 28, 2024

In a remote study, it would be possible for duplicate enrollment, falsified or fabricated eligibility source documents, or data completed by surrogates. Getting study drug and other study materials into the hands of a participant requires distribution via mail or courier, breaking the traditional chain of custody.

Clinical Trials 143

Clinical Trials Clinical Trials Trials Clinical Research 143

Pharma Tutor

DECEMBER 5, 2021

2 Department of Applied Chemistry, School of Vocational Studies & Applied Sciences, Gautam Buddha University, Gautam Buddha Nagar, Greater Noida, UP. Maheshwari 3 *. 1 Department of Applied Sciences, Pt LR College of Technology, Faridabad, Haryana. 3 Department of Chemistry, SBRM Govt PG College, Nagaur, Rajasthan. gcacs60@gmail.com.

52

52

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. Shunxi will also hold an option to negotiate rights to other CAR-T products, which include the licenced IP.

Gene Therapy 130

Gene Therapy Gene Development Clinical Trials 130

Rethinking Clinical Trials

MARCH 6, 2024

Food-as-Medicine observational studies have had a large correlation with improved health. The study found a null effect on HbA1c. The study did find substantial effects on diet and healthcare engagement. Discussion Themes -Why do you think it was a negative study? Food insecurity is associated with diabetes.

Clinical Trials 143

Clinical Trials Clinical Trials Medicine Trials 143

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.

Clinical Trials 143

Clinical Trials Clinical Trials Trials Development 143

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. In implementation studies, how can you blind outcome assessor? Learn more Visit the DECIPHeR website.

Clinical Trials 154

Clinical Trials Clinical Trials Trials Research 154

Rethinking Clinical Trials

OCTOBER 18, 2023

It may be suitable for studies on targeted populations but will depend on collection practices at a given health system. May be be best suited for specific studies. Discussion Themes -Have the data been used by PCORnet studies? It is new and has not been used widely across studies.

Clinical Trials 118

Clinical Trials Clinical Trials Clinical Research Research 118

Rethinking Clinical Trials

FEBRUARY 16, 2023

There are also concerns that obtaining consent could alter the “real-world” medical care being studied, may introduce an alteration of routine care, may introduce bias or make research impossible to conduct. Think about methods of notification, from detailed study-specific information to a general statement that research is being conducted.

Clinical Trials 130

Clinical Trials Clinical Trials Medicine Trials 130

Rethinking Clinical Trials

JULY 14, 2023

Tyson School of Medicine Slides Keywords Pragmatic Clinical Trial, GGC4H, Prevention Key Points Guiding Good Choices for Health Study (GGC4H) is about the Guiding Good Choices (GGC) intervention, a group-based program for parents and caregivers of younger adolescents (ages 9-14). 2) Can virtual GGC be delivered with fidelity?

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Rethinking Clinical Trials

JULY 13, 2023

Patients went through a screening by a study physician for eligibility. There were substantial improvements in the intervention group of the pilot study and improved guideline medical therapy that indicated that the virtual nudge strategy might be beneficial and scalable to multiple entities within an integrated healthcare system.

Clinical Trials 130

Clinical Trials Clinical Trials Scientist Research 130

Rethinking Clinical Trials

JANUARY 26, 2023

This study is looking at a particular subpopulation, where there is a lack of outcomes data. This is a collaborative study with Academic-Industry Partnership with oversight by an Academic Executive Committee. Study participants are managed within health systems in-line with local standard of care.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

NOVEMBER 1, 2022

The HERO TOGETHER study leveraged the HERO Registry to estimate real-world incidence of safety events among vaccinated individuals. The first trial undertaken by the HERO Program, HERO-HCQ, evaluated the efficacy of hydroxychloroquine (HCQ) to prevent COVID-19 in healthcare workers. No statistically significant benefit was found.

Trials 130

Trials Clinical Research Vaccination Vaccine 130

Rethinking Clinical Trials

DECEMBER 6, 2023

But this assumption may not be true in all studies or for all types of treatment. Researchers need to think very carefully about what is the possible exposure time curve and what is it the study is trying to estimate in the stepped-wedge trial? A key question is what is the estimand and what is most scientifically meaningful?

Trials 154

Trials Clinical Trials Clinical Trials Research 154

Rethinking Clinical Trials

APRIL 18, 2023

The 5 platform protocols are integrated rather than siloed, disparate studies to achieve efficiencies, allow researchers to rapidly assess targeted therapeutics and pivot as needed to new treatment arms, maximize knowledge gained from patient participation, and to enable cross-trial analysis and accelerated knowledge acquisition.

Clinical Trials 219

Clinical Trials Clinical Trials Trials Immune Response 219

Rethinking Clinical Trials

NOVEMBER 16, 2022

Data sharing has been in the context of the patient-level deidentified data from these studies. The context of PCT data sharing support arguments made elsewhere for engaging individuals who are going to be enrolled in these studies. Discussion Themes. Can you better define data sharing, is it the publication? pctGR, @Collaboratory1.

Clinical Trials 246

Clinical Trials Clinical Trials Trials Research 246

Rethinking Clinical Trials

FEBRUARY 13, 2023

All infants and children less than 2 years of age undergoing open heart surgery on cardiopulmonary bypass were eligible for the study with exclusions for diseases that implied high severity pre-bypass. Our study gave us a unique power to understand what happens after newborn cardiac surgeries. There were a number of limitations.

Trials 130

Trials Clinical Trials Clinical Trials Research 130

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 Studies have shown that BA.2 Studies are evaluating the risk of reinfection with BA.2

Protein 52

Protein Vaccination Vaccine Genetics 52

Rethinking Clinical Trials

JULY 27, 2022

The key clinical questions of the ACTIV-6 study are: how to help someone feel better faster with newly diagnosed mild-moderate COVID-19 and how to prevent hospitalizations or death in someone with newly diagnosed mild-moderate COVID-19? The study has closed the Fluvoxamine-50 and Ivermectin-600 arms. Vice Dean for Clinical Research.

Trials 173

Trials Pharmacy Medicine Clinical Trials 173

Rethinking Clinical Trials

MAY 25, 2023

A pilot study, called the ADAPT trial, demonstrated feasibility, similar in-patient compliance and similar post-discharge adherence for the 2 options. The study required an FDA exemption because Aspirin is not approved for this indication. The pragmatic randomized control trial was designed from a hospital policy perspective.

Trials 130

Trials Clinical Trials Clinical Trials Compliance 130

Scienmag

JANUARY 12, 2021

Researchers have found a simple way to eliminate almost all sequencing errors produced by a widely used portable DNA sequencer, potentially enabling scientists working outside the lab to study and track microorganisms like the SARS-CoV-2 virus more efficiently.

DNA 40

DNA Scientist Research Bioinformatics 40

Rethinking Clinical Trials

JUNE 7, 2023

Sites were selected based on their On-X AVR volume, and the study leveraged the surgeon/patient relationship for recruitment. The study used remote enrollment, and there was also a centralized outreach to patients with On-X AVR by mail to all U.S. patients with a link to clinicaltrials.gov to learn more about the study.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Cardiology 130

Rethinking Clinical Trials

MARCH 1, 2023

S1800A was a Phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for NSCLC patients previously treated with immunotherapy performed within the Lung-MAP platform. The study does not include tissue specimen collection, image submission, or patient-reported outcome instruments.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Packaging 130

Rethinking Clinical Trials

JULY 9, 2023

Designing interventions that can meet everyone’s needs can be a challenge in a study that involves rural/urban and racial/ethnic diversity. How quickly can these types of studies proceed from trial completion to release of results? Implementation mapping at the beginning of the design process is key.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Drug Discovery World

MARCH 2, 2023

The study shows that H3K4me3 ensures genes are transcribed and activated at the right time in a controlled manner, like a set of traffic lights regulating the flow of cars on a busy road. But, until now, scientists lacked an understanding of what the chemical tag does, despite many years of research.

Gene Expression 52

Gene Expression Gene DNA RNA 52