Rethinking Clinical Trials

JUNE 13, 2023

Wendy Weber, ND, PhD, MPH On May 16-17, 2023, over 100 members of the NIH Pragmatic Trials Collaboratory met in Bethesda, Maryland, for its annual Steering Committee meeting—an opportunity to network and hold rich discussions on key issues related to pragmatic research.

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Rethinking Clinical Trials

MAY 8, 2023

The NIH Pragmatic Trials Collaboratory is partnering with AcademyHealth to offer a 1.5-day Attendees will participate in facilitated, hands-on learning activities and interact with principal investigators of pragmatic clinical trials embedded in healthcare systems, including NIH Collaboratory Demonstration Projects.

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Pharmaceutical Technology

MAY 24, 2023

The AMP programme is a public-private partnership between a number of biopharmaceutical and life sciences companies, the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH), along with non-profit and other organisations. Topic sponsors are not involved in the creation of editorial content.

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Rethinking Clinical Trials

APRIL 20, 2023

The NIH Pragmatic Trials Collaboratory is partnering with AcademyHealth to offer a 1.5 Firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory will support and illustrate the topics presented and demonstrate how ePCTs in real-world settings are driving tomorrow’s outcomes.

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Rethinking Clinical Trials

JULY 5, 2023

June 23-24, 2023 : The NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop, “Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials Workshop,” at the Health Care Systems Research Network 2023 Annual Conference.

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Rethinking Clinical Trials

FEBRUARY 23, 2023

February 20, 2023 : The NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop, “Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials Workshop,” at the Health Care Systems Research Network 2023 Annual Conference.

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Rethinking Clinical Trials

FEBRUARY 8, 2023

She serves as cochair of the NIH Collaboratory’s Ethics and Regulatory Core. Wendler is the head of the Section on Research Ethics in the NIH Clinical Center and a member of the Ethics and Regulatory Core. Ho is a professor medicine at the University of Colorado and the principal investigator of the Nudge Demonstration Project.

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Rethinking Clinical Trials

OCTOBER 12, 2022

Crofford is also a co-principal investigator for FM-TIPS, an NIH Collaboratory Demonstration Project. Ali is an assistant professor of international health at Johns Hopkins University, Matthews is director of human research protections at Kaiser Permanente Washington, and Crofford is professor and chair of medicine at Vanderbilt University.

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Rethinking Clinical Trials

OCTOBER 18, 2022

Rachel Richesson, cochair of the NIH Pragmatic Trials Collaboratory’s Electronic Health Records (EHR) Core , will present this week at IMPACT Collaboratory Grand Rounds. She is working with the EHR Core to develop standards and quality metrics for EHR-based phenotyping, the topic of her upcoming Grand Rounds presentation.

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Rethinking Clinical Trials

NOVEMBER 9, 2022

Both Morain and Spector-Bagdady are members of the NIH Collaboratory’s Ethics and Regulatory Core. Spector-Bagdady is interim codirector of the Center for Bioethics and Social Sciences in Medicine and an assistant professor of obstetrics and gynecology at the University of Michigan Medical School. Join the online meeting.

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Rethinking Clinical Trials

DECEMBER 20, 2022

This training workshop introduces concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs), and provides firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory Demonstration Projects. Topic Discussions. Speaker Biographies. Program Overview. Participant Guide.

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Rethinking Clinical Trials

JUNE 27, 2022

The 14 articles bring together leaders, researchers, biostatisticians, and bioethicists—including members of the NIH Pragmatic Trials Collaboratory—who are rethinking key aspects of the development, conduct, and oversight of clinical trials. The special issue can be found on the Contemporary Clinical Trials website.

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Pharmaceutical Technology

MAY 30, 2023

Amplo Biotechnology has received a fast track phase I/II STTR grant from the NIH-NIAMS [National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases] for its gene therapy AMP-201. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

AUGUST 2, 2022

The latest development comes after GreenLight signed a partnership with the US National Institutes of Health (NIH) to develop Covid-19 vaccines against new variants. Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Rethinking Clinical Trials

FEBRUARY 9, 2023

Firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory will support and illustrate the topics presented and demonstrate the importance of leveraging networks throughout the course of ePCTs.

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Rethinking Clinical Trials

JUNE 26, 2023

Pérez-Stable, MD This year’s annual Steering Committee meeting for the NIH Pragmatic Trials Collaboratory featured health equity as a central topic of discussion. In an interview after his keynote presentation, Eliseo J.

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Rethinking Clinical Trials

AUGUST 10, 2022

The NIH Pragmatic Trials Collaboratory is launching a special Grand Rounds series to examine ethical and regulatory challenges in pragmatic clinical trials. Steven Joffe, MD, MPH, will give a keynote presentation on Sept. The series will include an additional 5 moderated webinar discussions with panels of experts.

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Rethinking Clinical Trials

AUGUST 29, 2022

The NIH Pragmatic Trials Collaboratory is launching a special Grand Rounds series to examine ethical and regulatory challenges in pragmatic clinical trials. Steven Joffe will give a keynote presentation on September 9th. The series will include an additional 5 moderated webinar discussions with panels of experts.

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Worldwide Clinical Trials

NOVEMBER 10, 2023

At this year’s annual Pain Therapeutics Summit , which took place in San Diego, CA, October 19 to 20th, I heard brilliant presentations on novel pain medication development, targeted discoveries, pain classifications, the NIH HEAL Initiative , trial designs, biomarkers, and others. As mentioned, these are but a few topics for contemplation.

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Rethinking Clinical Trials

JULY 7, 2022

Our wish list for future contributions includes: More cross-core collaboration—specifically, conferring with the Biostatistics and Study Design Core on quantitative measurement questions around topics like meaningful change and longitudinal responsiveness within the context of pragmatic trials. Emily O’Brien.

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FDA Law Blog

AUGUST 23, 2022

These recommendations come based on the latest National Institutes for Health (NIH) and University of Massachusetts Chan Medical School study which was funded by the NIH Rapid Acceleration of Diagnostics (RADx) program. See our previous post on the topic here.)

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Drug Discovery World

JULY 8, 2022

The meeting will include a range of plenary sessions and working group discussions that cover topics on how vaccines can mitigate the effects of environmental change; vaccine development to prevent human-animal disease transmission; equitable access to vaccines and how to maximise the impact of vaccines to meet sustainability goals. .

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The Pharma Data

FEBRUARY 1, 2021

NIH Launches Database to Study COVID-19-Related Neurological Complications. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox. Professional. MONDAY, Feb. The new database, COVID-19 Neuro Databank/Biobank (NeuroCOVID), will be maintained by NYU Langone Health in New York City. .”

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Eye on FDA

OCTOBER 21, 2020

And now, three agencies that have seen an erosion in public confidence – FDA, CDC and NIH, will participate in an FDA Advisory Committee meeting that will discuss vaccine development. The agenda has been posted for the October 22 meeting, and the discussion will be available to view on YouTube, according to FDA Commissioner Hahn.

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pharmaphorum

JANUARY 18, 2021

The need for diversity in clinical trial populations has been a topic of discussion across regulators and the industry in general for decades.

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Drug Channels

FEBRUARY 6, 2024

PAP – Patient Assistance & Access Programs Download Agenda | See Who’s Speaking The experts will be taking the most pressing challenges industry is facing head on, including: Emerging Policy Changes and Enforcement Actions The Impact of AFPs on PAPs Program Automation for Operational Efficiency Ensuring Health Equity Where It Matters Most Patient (..)

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Pharmaceutical Technology

NOVEMBER 29, 2022

Earlier this month, New Jersey-based Silo Pharma announced the start of an IND-enabling study of a topical ketamine formulation for fibromyalgia, a chronic condition that causes pain and fatigue. The chief sources of funding for this area of research is grants from foundations or federal institutions such as the NIH, he says.

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ACRP blog

JUNE 15, 2023

At UIC, the authors are part of an NIH-funded study on using guided relaxation and acupuncture to reduce the chronic pain of sickle cell disease. ePCTs test the effectiveness of medical interventions in real-world settings, but the authors say they may still leave out people who are from underrepresented and underserved groups.

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Roots Analysis

AUGUST 18, 2023

You can also download the SAMPLE REPORT on this topic by Roots Analysis by clicking on the link here. The maximum number of grants were awarded in 2021. link] The post Organ-on-Chip: Rising Need of Products and Technologies appeared first on Blog.

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ACRP blog

JUNE 15, 2023

At UIC, the authors are part of an NIH-funded study on using guided relaxation and acupuncture to reduce the chronic pain of sickle cell disease. ePCTs test the effectiveness of medical interventions in real-world settings, but the authors say they may still leave out people who are from underrepresented and underserved groups.

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Drug Discovery World

JULY 5, 2023

He was then an American Cancer Society Postdoctoral Fellow and National Research Service Awardee at the NIH, as well as doing a second postdoc at the University of Wisconsin-Madison. As part of his graduate work he invented the gel-shift or EMSA assay for the study of protein-DNA interactions.

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Advarra

NOVEMBER 29, 2022

The FDA recently announced a new initiative as part of its NIH Accelerating Medicines Partnership Program. A major topic of discussion is the significant problems in multi-country clinical trials due to the different requirements of the parties involved. Trend Two: The Bespoke Gene Therapy Consortium.

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XTalks

SEPTEMBER 29, 2022

Read on to learn more from the AHA about topics related to CVD clinical trials and more. AHA/ASA is the second largest funder of cardiovascular research after the NIH. What are some challenges, including legal and regulatory barriers, to utilizing telehealth when treating patients with CVD and stroke?

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Rethinking Clinical Trials

MARCH 23, 2023

Both of the target articles for the special issue are from the NIH Pragmatic Trials Collaboratory’s Ethics & Regulatory Core. Unlike AJOB ‘s typical Open Peer Commentaries, commentaries for the special issue may be written either in response to the 2 target articles or on the topic of pragmatic trials in general.

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Find Me Cure

NOVEMBER 1, 2019

The high prevalence of MG in women in their 20s and 30s makes family planning a difficult topic for many myasthenia patients. According to an NIH report , most drugs used for the treatment of MG come with no considerable risks for the baby – even the ones that cross the placenta. It’s strongly recommended that you don’t.

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Pharmaceutical Technology

JULY 18, 2022

The KidCOVE trial is being carried out in partnership with the National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID). Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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XTalks

FEBRUARY 26, 2021

The problem was that the oil was too viscous, or sticky, making its topical application difficult. In the same year, another group submitted the genome of a different HeLa cell line strain for publication, with funding for the research having come from the National Institutes of Health (NIH).

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