Rethinking Clinical Trials

MARCH 27, 2025

Its becoming more expensive and time-consuming to move a drug from the clinical trial stage to approval. Patient recruitment is the leading driver of costs in clinical trials, and 55% of trials that fail to complete cite low accrual rate as the reason for study termination.

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Rethinking Clinical Trials

MARCH 10, 2025

In an article published online ahead of print , leaders from the NIH Pragmatic Trials Collaboratory share lessons learned about the importance of independent oversight by a safety office or data and safety monitoring board in pragmatic clinical trials, even for trials deemed to have minimal risk.

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Rethinking Clinical Trials

MARCH 7, 2024

Stephanie Morain In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists and implementation scientists argue for a “presumptive default” that the results of pragmatic clinical trials should be incorporated into healthcare delivery processes. Read the full article.

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Rethinking Clinical Trials

NOVEMBER 25, 2024

Drawing on experiences from the NIH Collaboratory Trials, authors of a new article in Contemporary Clinical Trials describe the challenges they encountered when relying on data from the electronic health record (EHR) to monitor outcomes and deliver interventions in pragmatic clinical trials embedded in healthcare systems.

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XTalks

DECEMBER 19, 2024

Despite advancements in neuroscience and psychiatry, clinical trials for mental health conditions such as major depressive disorder (MDD), schizophrenia, bipolar disorder and generalized anxiety disorder face unique challenges. One of the main challenges lies in defining and selecting appropriate trial populations.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 14, 2024

A large clinical trial in South Africa and Uganda has shown that a twice-yearly injection of a new pre-exposure prophylaxis drug gives young women total protection from HIV infection. All three medications […]

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Pharmaceutical Technology

AUGUST 15, 2024

Strong measures must be in place to safeguard confidential patient data when deploying AI to optimise clinical trial translations.

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XTalks

APRIL 8, 2025

Global rare disease clinical trials face unique challenges due to small patient populations, complex logistics, diverse regulatory environments and cultural differences. Clinical Trial Manager/Sr. These measures enhance recruitment, retention and overall trial success.

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XTalks

DECEMBER 10, 2024

The surge in MASH cases stresses the need for early diagnosis, timely intervention and precise, reliable methodologies in clinical trials to evaluate new therapies effectively. Read on to gain insights from Medpace experts about advancements in imaging, histology and innovative techniques for MASH clinical trials.

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Rethinking Clinical Trials

DECEMBER 3, 2024

In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists explores the ethical obligation to share aggregate results from pragmatic clinical trials with research participants. The article was published online ahead of print in Clinical Trials.

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Rethinking Clinical Trials

MARCH 19, 2025

They take place in real-world health settings, where clinical resources can be scarce. However, spillover due to resource constraints is absent from the major frameworks that inform clinical trial methods. However, spillover due to resource constraints is absent from the major frameworks that inform clinical trial methods.

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Bio Pharma Dive

APRIL 8, 2024

Underrepresentation of women in clinical trials affects the resulting drugs that become available later. Even small changes could boost participation.

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Rethinking Clinical Trials

APRIL 17, 2025

Researchers applied the “target trial emulation framework” to highlight important design considerations for observational studies that use real-world data to emulate randomized clinical trials. Thus, little is known about the safety of anti-amyloid therapies in real-world settings. Read the full report.

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Rethinking Clinical Trials

APRIL 2, 2025

In this Friday’s PCT Grand Rounds, Bill Heerman of Vanderbilt University will present “A Digital Health Behavior Intervention to Prevent Childhood Obesity: The Greenlight Plus Randomized Clinical Trial.” ” The Grand Rounds session will be held on Friday, April 4, 2025, at 1:00 pm eastern.

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Rethinking Clinical Trials

JANUARY 9, 2025

The NIH Pragmatic Trials Collaboratory will hold a virtual workshop on February 5 and 6, 2025, on Digging Into Dilemmas of Pragmatic Clinical Trials. To date, the NIH Collaboratory has launched 35 pragmatic trials that are conducted within healthcare systems at over 1,400 clinical sites.

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Rethinking Clinical Trials

NOVEMBER 20, 2024

Paul Karanicolas In this Friday’s PCT Grand Rounds, Paul Karanicolas of the University of Toronto will present “Tranexamic Acid in Patients Undergoing Liver Resection: The HeLiX Randomized Clinical Trial.” ” The Grand Rounds session will be held on Friday, November 22, 2024, at 1:00 pm eastern.

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Trials Clinical Trials Clinical Trials Research 173

Rethinking Clinical Trials

DECEMBER 5, 2024

Sheana Bull, principal investigators for Nudge Text message–based reminders to patients who delayed refilling their cardiovascular medications did not improve medication adherence compared with usual care in the recently completed Nudge trial. The results of the study were published online ahead of print in JAMA. Learn more about Nudge.

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Drug Patent Watch

JANUARY 23, 2025

One key aspect of this journey is the clinical trial design and execution process a critical step that can make or break the success of a biosimilar product. When it comes to designing clinical trials for biosimilars, there are several key considerations to keep in mind. Share your insights in the comments below!

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Rethinking Clinical Trials

APRIL 22, 2025

Such notifications should be considered the default for clinical trials conducted under a waiver of informed consent, argue the authors of a new report from the NIH Pragmatic Trials Collaboratory. The open-access article was published online ahead of print this week in Learning Health Systems. Read the full report.

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CTTI (Clinical Trials Transformation Initiative)

MARCH 19, 2025

A new publication from the FDA Oncology Center of Excellence (OCE) and the Clinical Trials Transformation Initiative (CTTI), published in the Clinical Cancer Research journal, provides important insights into how decentralized clinical trial (DCT) elements were used in cancer trials leading to FDA approval during the COVID-19 pandemic.

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Rethinking Clinical Trials

DECEMBER 18, 2024

This was a multisite, practice-based, comparative effectiveness randomized clinical trial conducted at six public hospitals and three academic medical centers in New York City. Sustainment can be an Achilles Heel for embedded trials, as programs that have been shown to be successful arent always covered by insurance.

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Rethinking Clinical Trials

JULY 23, 2024

In an invited commentary published this month in Circulation: Cardiovascular Quality and Outcomes , authors from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core describe the recurring and emerging ethical issues in pragmatic clinical trials. Learn more about the Ethics and Regulatory Core.

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Rethinking Clinical Trials

NOVEMBER 13, 2024

In this Friday’s PCT Grand Rounds, Kit Delgado of the University of Pennsylvania will present “Pragmatic Randomized Trial of Smartphone-Based Nudges to Reduce Distracted Driving Among US Auto Insurance Customers.” ” The Grand Rounds session will be held on Friday, November 15, 2024, at 1:00 pm eastern.

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Bio Pharma Dive

JULY 1, 2024

Study results are expected for a pair of closely watched obesity drugs, while key tests await for a high-priced AbbVie acquisition and one of 2023’s largest IPOs.

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Worldwide Clinical Trials

APRIL 15, 2025

Early Phase Unit, Worldwide Clinical Trials Neurodegenerative diseases represent a diverse group of progressive disorders characterized by the loss of structure and function of neurons. Integration of fluid biomarkers, imaging, and genetic profiling enhances diagnostic precision and provides valuable tools for clinical trials in ALS.

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Pharmaceutical Technology

SEPTEMBER 4, 2024

By integrating the best practices from decentralized trials, CROs can optimize efficiencies and streamline site-based operations, ensuring that site-centric trials remain effective and innovative.

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Rethinking Clinical Trials

JANUARY 21, 2025

Keith Goldfeld, principal investigators for PRIM-ER An evidence-based training program to improve the capacity of emergency department care teams to communicate with seriously ill older patients about palliative care did not lead to lower rates of hospital admission, according to the results of the PRIM-ER trial. Learn more about PRIM-ER.

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Rethinking Clinical Trials

MARCH 4, 2025

Researchers with PRIM-ER, an NIH Collaboratory Trial, published 2 innovative statistical techniques for evaluating intervention effects in stepped-wedge, cluster randomized trials. In stepped-wedge trials, the clusters are randomized into several groups, and all groups start the trial in the control condition.

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Bio Pharma Dive

JANUARY 2, 2024

A non-addictive pain pill faces its definitive test, while study results in ALS, a rare heart disease and lung cancer could have far-reaching implications.

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Rethinking Clinical Trials

DECEMBER 5, 2023

Health Data Research Network (HDRN) Canada is now accepting applications for its Pragmatic Trials Training Program. There will be an emphasis on experiential learning for future trial leaders and postdoctoral fellows in the program through the development of a pragmatic trial protocol.

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