Rethinking Clinical Trials

AUGUST 9, 2023

Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials Description Joseph Ali, Tanya Matthews, and Leslie J. Crofford discuss responding (or not) to signals of potential clinical significance in pragmatic clinical trials.

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Rethinking Clinical Trials

AUGUST 9, 2023

Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape Description Kayte Spector-Bagdady and Stephanie Morain discuss the impact of a changing policy landscape on data sharing and pragmatic clinical trials.

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Rethinking Clinical Trials

FEBRUARY 28, 2024

In this Friday’s PCT Grand Rounds, Joseph Doyle of the Massachusetts Institute of Technology (MIT) will present “Effect of an Intensive Food-as-Medicine Program on Health and Healthcare Use: Evidence From a Randomized Clinical Trial.” Doyle is the Erwin H. Join the online meeting.

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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. Food-as-Medicine observational studies have had a large correlation with improved health. 9% of the U.S.

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Rethinking Clinical Trials

JULY 31, 2023

Building a Study Team for a Pragmatic Clinical Trial Description NIH Collaboratory investigator Dr. Lesley Curtis shares tips for building effective study teams for pragmatic clinical trials.

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Rethinking Clinical Trials

JUNE 28, 2023

Hernandez is a professor of medicine and director of the Duke Clinical Research Institute at Duke University; he is a co–principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center. Dr. Tenaerts is the chief scientific officer of Medable, a cloud computing platform for decentralized clinical trials.

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Drug Discovery World

MAY 17, 2023

Leveraging historical trial databases has become commonplace in assessing the feasibility of trials in therapeutic areas with a large breadth of clinical development history. EHR data also has a key role to play in designing future clinical trials.

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Antidote

OCTOBER 3, 2023

Clinical trials are an integral part of the medical industry, as they are required for any new treatment to be approved. Every medicine used today, whether prescription or over the counter, is a result of the rigorous research process that is a clinical trial — and for these trials to take place, volunteers are vital.

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Rethinking Clinical Trials

DECEMBER 20, 2023

Yet enrollment of ethnic minorities in NIH clinical trials and for trials studying approved devices and drugs remains low. Further efforts are urgently needed to increase diversity in the cardiology workforce, which will improve clinical trial diversity and cardiovascular health for all.

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Drug Discovery World

APRIL 4, 2024

EnteroBiotix, a Glasgow, UK based biotechnology company, has dosed the first patient in a clinical trial designed to evaluate EBX-102-02 for the treatment of irritable bowel syndrome (IBS).

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Outsourcing Pharma

MARCH 11, 2024

On March 7, Celadon Pharmaceuticals plc, a leading UK-based pharmaceutical company specializing in cannabis-based medicines, unveiled promising findings from an early economic analysis of its chronic pain clinical trial, dubbed CANPAIN.

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Rethinking Clinical Trials

AUGUST 17, 2022

Michelle Kelsey will present “Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change.” Dr. Bloomfield is an associate professor of medicine and global health and Dr. Kelsey is an assistant professor of medicine at Duke University. Join the online meeting. Join the online meeting.

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Clinical Trials Clinical Trials Trials Medicine 130

Pharmaceutical Technology

OCTOBER 25, 2023

A blockchain system intended to ensure the safety and authenticity of medicines across the supply chain could change the way that medical professionals work, as discussed at the 11th Annual Clinical Trial Supply Nordics conference.

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Rethinking Clinical Trials

JUNE 27, 2022

A special series of articles addressing pragmatic and virtual trials appears this week in the journal Contemporary Clinical Trials and offers practical approaches to the many challenges clinical trials face. The special issue can be found on the Contemporary Clinical Trials website.

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Rethinking Clinical Trials

AUGUST 7, 2023

Keynote: Diverse Representation Among Clinical Trial Participants: Why It’s Important and How Can We Improve Description Dr. Clyde Yancy presents the keynote session for the Diversity Workshop Grand Rounds series. Biography Clyde W.

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Olympian Clinical Research

MARCH 19, 2024

Clinical trials are essential for advancing medical knowledge and developing new treatments that can improve patient care and outcomes. Participating in a clinical trial is a significant decision that can have profound benefits, not only for the individual participant but also for future patients and the broader medical community.

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Pharmaceutical Technology

MARCH 23, 2023

This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinical trial regulation in the UK with expedited timelines at several stages. The MHRA hopes this new framework “will remove obstacles to innovation” and “streamline the regulation of clinical trials” amongst other things.

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Pharmaceutical Technology

JUNE 15, 2023

But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Pharma R&D teams are solving this problem by leveraging the power of artificial intelligence (AI) in clinical trials to save time and money.

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ACRP blog

JANUARY 3, 2024

Historically, patient recruitment and retention have been pressing issues within the clinical trial space. Eighty-five percent of trials fail to recruit enough patients, while 80% are delayed due to other factors like participant dropouts. Diversity and Equity at the Forefront The U.S.

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Clinical Trials Clinical Trials Trials Medicine 122

Rethinking Clinical Trials

AUGUST 24, 2022

Areef Ishani of the University of Minnesota will present “The Diuretic Comparison Project: A Large Pragmatic Clinical Trial.” The post August 24, 2022: Diuretic Comparison Project, a Point-of-Care Clinical Trial, to Be Featured in PCT Grand Rounds appeared first on Rethinking Clinical Trials.

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Clinical Trials Clinical Trials Trials Medicine 130

Pharmaceutical Technology

MARCH 27, 2023

Regenerative medicines in early-stage development (preclinical, discovery, or investigational new drug [IND]/ clinical trial application [CTA] filed status) have seen a change in drug targets compared to therapies in late-stage development (Phase II to pre-registration stage).

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Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors.

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Clinical Trials Clinical Trials Trials Dermatology 130

Bio Pharma Dive

MAY 19, 2023

The biotech, best known for its vaccine research, said its clinical trial is the first to report results of a messenger RNA therapeutic designed for intracellular protein replacement.

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Rethinking Clinical Trials

FEBRUARY 28, 2024

            Speakers Adrian Hernandez, MD Executive Director, Duke Clinical Research Institute Vice Dean, Duke University School of Medicine Christopher J. The global decentralized clinical trial market is expected to grow at a compound annual growth rate of 30.1% from 2021 to 2026.

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Clinical Trials Clinical Trials Trials Clinical Research 141

XTalks

JANUARY 17, 2024

They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinical trials or need to start planning to include. Evolution in Oncology Clinical Trial Design Recent discussions at ESMO highlight a shift in how clinical trials are designed and conducted.

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Rethinking Clinical Trials

APRIL 17, 2024

Joseph Ross In this Friday’s PCT Grand Rounds, Joseph Ross of Yale University will present “The Yale Open Data Access (YODA) Project: 10 Years of Clinical Trial Data Sharing.” The YODA Project promotes open science, research transparency, and the sharing of clinical research data to support healthcare research.

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Clinical Trials Clinical Trials Clinical Research Trials 161

BioPharma Reporter

MARCH 5, 2024

Neurogene, a clinical-stage company developing genetic medicines, is expanding its ongoing phase 1/2 clinical trial investigating NGN-401 as a treatment for female pediatric patients with Rett Syndrome.

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AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 8, 2024

The Drugs Technical Advisory Board (DTAB) has suggested to the ministry of health and family welfare (MoHFW) to write to the ministry of corporate affairs to mandate the pharma companies to spend almost one per cent of their net profit for providing free medicines in medicine banks as part of the Corporate Social Responsibility (CSR). […]

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Pharmaceutical Technology

APRIL 20, 2023

According to Daniel Tanner, chief commercial officer at Cerba Research, this patient centricity comes with exciting possibilities to improve trials for all stakeholders. Clinical trials were really not optimised from the perspective of the patient, site orthe sponsor; they are increasingly cost ineffective, and they take a lot of time.

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XTalks

FEBRUARY 21, 2024

Black participation in clinical trials, and the underrepresentation of minority groups in general in trials, remains low. It is therefore important to work towards increasing Black participation in clinical trials, which begins with understanding the barriers to participation and taking steps to address them.

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ACRP blog

MARCH 12, 2024

Global Disruptions, Health Equity, and Data Sharing International clinical trials are essential to evaluating the safety and efficacy of new treatments, but their success can be hampered by a variety of challenges. Pharma and biotech companies already face significant challenges in conducting international clinical trials.

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Clinical Trials Clinical Trials Trials Regulation 59

Drug Discovery World

FEBRUARY 1, 2023

Michael Sassano , CEO at SOMAÍ Pharmaceuticals looks at what’s needed throughout Europe to help increase access to medicinal cannabis and the current state of pharmaceutical research in this area. The use of medicinal cannabis across much of the world is still in its infancy.

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Cloudbyz

DECEMBER 15, 2023

Veterinary clinical trials and human clinical trials share some similarities, but there are key differences owing to the distinct nature of the subjects involved—animals versus humans. The aim is to improve the well-being of animals, enhance veterinary medicine, and contribute to public health (e.g.,

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Rethinking Clinical Trials

JANUARY 3, 2024

In this Friday's PCT Grand Rounds, Rui Wang of Harvard Medical School will offer the final session in our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with "Methods for Handling Missing Data in Cluster Randomized Trials." The session will be held on Friday, January 5, at 1:00 pm eastern.

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Rethinking Clinical Trials

APRIL 18, 2023

Learn more Visit [link] Discussion Themes – What experts are being convened for the different trials? We have people with experience with post-viral symptoms, treating ME/CFS, general COVID knowledge, biomarker experience, clinical trials, patient-reported outcomes, and more. It’s all over the place.

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Pharmaceutical Technology

AUGUST 11, 2022

Gemini Therapeutics has signed a definitive agreement to merge with Disc Medicine in an all-stock deal to create a clinical-stage biopharmaceutical company. The merged company is expected to be named Disc Medicine, which will have corporate headquarters in Watertown, Massachusetts, US.

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Drug Discovery World

NOVEMBER 8, 2023

Deepika Khedekar , Associate Centralized Clinical Lead at IQVIA, explains how artificial intelligence could make clinical trials more accurate, accessible and standardised. Tapping into the capabilities of AI One reason AI may accelerate clinical trials is its ability to rapidly process and analyse vast amounts of data.

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