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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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

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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Pharma Mirror

DECEMBER 23, 2024

Clinical trials are the foundation of medical innovation, paving the way for groundbreaking therapies. Yet for many, the idea of joining a trial can feel intimidating or unclear. Have you ever wondered how life-saving treatments for cancer, Alzheimers, or chronic diseases come to life?

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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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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

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

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

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

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. Join the online meeting.

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Trials Clinical Trials Clinical Trials Medicine 147

Rethinking Clinical Trials

JANUARY 13, 2025

Rachel Winer, Dr. Amanda Petrik, and Dr. Jasmin Tiro, principal investigators of the STEP-2 trial The NIH Pragmatic Trials Collaboratory is pleased to welcome the STEP-2 trial (Self-Testing for Cervical Cancer in Priority Populations) to its portfolio of innovative NIH Collaboratory Trials.

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Trials Clinical Trials Clinical Trials Research 130

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. Join the online meeting.

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Trials Clinical Trials Clinical Trials Research 173

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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Trials Clinical Trials Clinical Trials Medicine 173

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

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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Rethinking Clinical Trials

JANUARY 29, 2025

ARBOR-Telehealth, an NIH Collaboratory Trial, is evaluating the use of a telehealth physical therapy strategy for patients who present to primary care clinics with low back pain in rural communities. ” The Grand Rounds session will be held on Friday, January 31, 2025, at 1:00 pm eastern. Join the online meeting.

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Trials Clinical Trials Clinical Trials Medicine 173

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. Similar guidance is lacking for pragmatic trials.

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Rethinking Clinical Trials

FEBRUARY 12, 2025

In this Friday’s PCT Grand Rounds, Angelo Volandes of Dartmouth Health and James Tulsky of Dana-Farber Cancer Institute will present “A Cluster Randomized, Stepped-Wedge Pragmatic Trial to Enhance Goals-of-Care Communication for Older Adults With Cancer (ACP-PEACE).” Join the online meeting.

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Trials Medicine Clinical Trials Clinical Trials 147

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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Clinical Trials Clinical Trials Trials Research 97

Bio Pharma Dive

JUNE 20, 2024

The agency has lifted a partial trial suspension based on one-year data showing PTC’s pill suppressed a key protein associated with the disorder.

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Trials Protein 307

XTalks

JANUARY 16, 2025

BlueRock Therapeutics, a subsidiary of Bayer AG, is making waves in the treatment of Parkinsons disease by advancing its investigational cell therapy, bemdaneprocel, to a Phase III clinical trial. The clinical advancement follows a thorough review of Phase I trial data under the FDAs Regenerative Medicine Advanced Therapy (RMAT) designation.

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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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Clinical Trials Clinical Trials Trials Gene Therapy 88

Bio Pharma Dive

JANUARY 7, 2025

Denali’s medicine and a similar one from Calico Life Sciences and AbbVie were not much different than a placebo, bringing the tally of failed drugs in the innovative “Healey platform trial” to seven.

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Rethinking Clinical Trials

DECEMBER 17, 2024

December 8, 2024 : The NIH Pragmatic Trials Collaboratory hosted a workshop at AcademyHealth's 17th Annual Conference on the Science of Dissemination and Implementation in Health. O'Brien, PhD Session 1: What Are Embedded Pragmatic Clinical Trials? Check, PhD Session 3: Engaging With Health System and Community Partners Hayden B.

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Rethinking Clinical Trials

MARCH 6, 2025

In recent months, 5 of the newest NIH Collaboratory Trials have begun to enroll research participants. The trial is supported by the National, Heart, Lung, and Blood Institute (NHLBI). The trial is supported by the National Institute on Aging. The study is supported by the National Institute of Nursing Research.

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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. Nicola Owen, PhD, MBBS, Medical Directorthey shared insights into the operational and medical strategies that support the design and conduct of MASH clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 105

XTalks

NOVEMBER 15, 2024

Syros Pharmaceuticals announced that its cancer drug tamibarotene failed to meet its primary endpoint in the SELECT-MDS-1 Phase III trial. The placebo-controlled SELECT-MDS-1 trial involved 190 patients with complete response rate (CRR) being the study’s primary endpoint. percent and 18.8

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Bio Pharma Dive

SEPTEMBER 26, 2024

The withdrawal comes as trial results indicate safety concerns with the drug, Oxbryta, which was first approved in the U.S.

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Rethinking Clinical Trials

MARCH 19, 2025

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. These conditions are fairly common in pragmatic trials. Trials 25, 833 (2024).

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Clinical Trials Clinical Trials Trials Development 100

Bio Pharma Dive

NOVEMBER 11, 2024

After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and unrelated to vaccination.

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Vaccine Vaccination Trials 261