Rethinking Clinical Trials

JUNE 26, 2025

In a new episode of the Rethinking Clinical Trials Podcast, Rich Platt, Hayden Bosworth, and Greg Simon of the NIH Pragmatic Trials Collaboratory discuss their JAMA Viewpoint, “Making Pragmatic Clinical Trials More Pragmatic.” Listen and subscribe to the podcast on SoundCloud or Apple Podcasts.

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Trials Clinical Trials Clinical Trials 147

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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Trials Clinical Trials Clinical Trials Research 124

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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Clinical Trials Clinical Trials Trials Cardiology 147

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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Clinical Trials Clinical Trials Trials Clinical Research 130

Rethinking Clinical Trials

JUNE 19, 2025

There are challenges with ethical oversight in clinical trials, particularly when comparing existing therapies in widespread clinical use. But the reality isn’t so tidy: A clinical trial really might be someone’s “best treatment option.” Randomized trials will require case-by-case evaluation.

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Clinical Trials Clinical Trials Trials Research 162

Rethinking Clinical Trials

JUNE 16, 2025

The NIH Pragmatic Trials Collaboratory held its 2025 Annual Steering Committee Meeting in Bethesda, Maryland, on May 28 and 29. The program’s leadership discussed evolving approaches to pragmatic clinical trials and considered the latest developments in the landscape of pragmatic research. Learn more about the NIH Collaboratory Trials.

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Trials Clinical Trials Clinical Trials Research 130

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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Clinical Trials Clinical Trials Trials Development 130

ACRP blog

MAY 13, 2025

The poster on Understanding the Role of CROs and Sponsors During the Feasibility Process to Increase Enrollment for Racial and Ethnic Minorities in Clinical Trials was judged the best of the 10 posters accepted for presentation at the recent conference in New Orleans, La.

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Clinical Trials Clinical Trials Trials Research 104

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

Pharma Times

JULY 9, 2025

Importantly, the trial found no emergence of bacterial resistance to BX004 and showed preservation of the healthy microbiome, addressing key limitations of traditional antibiotics in this patient group. BiomX has already initiated a phase 2b trial of BX004, with topline results expected in the first quarter of 2026.

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Trials Clinical Research Bacteria Engineer 121

Rethinking Clinical Trials

JUNE 23, 2025

A new section of the Living Textbook of Pragmatic Clinical Trials describes considerations for choosing patient-reported outcome measures in pragmatic clinical trials. The post June 23, 2025: How to Choose Patient-Reported Outcome Measures in Pragmatic Clinical Trials? appeared first on Rethinking Clinical Trials.

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Clinical Trials Clinical Trials Trials Development 113

Medical Xpress

JUNE 23, 2025

Skin grafts genetically engineered from a patient's own cells can heal persistent wounds in people with an extremely painful dermatologic disease, a Stanford Medicine-led clinical trial has shown.

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Genetic Engineering Gene Therapy Dermatology Trials 123

Rethinking Clinical Trials

JUNE 10, 2025

Trials are expensive and take a long time; they’re designed to answer only 1 question; they commonly provide results that are underpowered and are therefore uninformative; they aren’t generalizable; and more. Platform trials attempt to answer multiple questions within a single trial.

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Trials Clinical Trials Clinical Trials Research 113

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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Trials Clinical Trials Clinical Trials Gene Therapy 104

Rethinking Clinical Trials

JUNE 12, 2025

For a variety of reasons, the application of ethical principles and regulations regarding informed consent can be complex for pragmatic clinical trials. For a variety of reasons, the application of ethical principles and regulations regarding informed consent can be complex for pragmatic clinical trials.

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Trials Clinical Trials Clinical Trials Regulation 100

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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Clinical Trials Clinical Trials Trials FDA Approval 75

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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Nurses Clinical Trials Clinical Trials Trials 100

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

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

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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Trials HR Immune Response FDA Approval 105

Rethinking Clinical Trials

JULY 3, 2025

Natalia Morone, principal investigator for OPTIMUM Trust in their clinicians, positive interactions with study staff, and opportunities for social connection can improve recruitment, retention, and engagement with research participants, according to focus groups of participants in the OPTIMUM trial. Learn more about OPTIMUM.

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Clinical Trials Clinical Trials Trials Research 147

Bio Pharma Dive

JULY 8, 2025

The cell therapy developer, which raised nearly $500 million in 2023 on the promise of its CAR-T work, has floundered since a safety setback forced it to scrap its lead candidate.

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Trials Development 161

ACRP blog

JUNE 13, 2025

The development of machine learning (ML) models has enabled professionals to perform risk prediction for events such as trial failure,” notes Aleksa Jovanovic, MD, PhD, a Scientific Engagement and Innovation Specialist with Wemedoo AG in Switzerland, in the latest issue of Clinical Researcher (June 2025).

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Clinical Trials Clinical Trials Trials Clinical Research 93

FDA Law

JANUARY 30, 2025

However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.

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Trials Drugs Cosmetics Development 105

XTalks

MARCH 14, 2025

mg), underperformed in its latest clinical trial, leading to a dip in the companys share price. In response to the trial outcomes, Novos shares declined by approximately 8% this week. Novo shared the latest data from the Phase III REDEFINE 2 trial evaluating the drug in overweight or obese patients with type 2 diabetes.

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Trials Drugs Clinical Trials Clinical Trials 89

XTalks

NOVEMBER 19, 2024

In clinical research, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinical trial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinical trial designs. Baker McDowell, Head of Regulatory Strategy.

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Clinical Trials Clinical Trials Trials Production 64

ACRP blog

JULY 16, 2025

Clinical trials are typically seen as engines of innovation, but for economically disadvantaged individuals, they can also be a gateway to care—particularly for chronic diseases that are expensive to manage. Clinical trials allow participants to access cutting-edge treatments without out-of-pocket costs. billion annually.

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Clinical Trials Clinical Trials Trials Clinical Research 66

Worldwide Clinical Trials

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

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Gene Therapy Clinical Supply Trials Gene 182

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. What are your thoughts on the future of biosimilars?

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Clinical Trials Clinical Trials Trials Production 71

Rethinking Clinical Trials

NOVEMBER 26, 2024

The post November 26, 2024: Hybrid Methods Improve Collection of Patient-Reported Outcome Measures in Rural and Underserved Populations appeared first on Rethinking Clinical Trials. The article was published this week in Applied Clinical Informatics.

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Trials Clinical Trials Clinical Trials Research 147