article thumbnail

November 21, 2024: Are Pragmatic Trials Living Up to the Promise of Improving Representativeness?

Rethinking Clinical Trials

In a new commentary, members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core explore the potential of pragmatic trials to improve demographic representativeness and health equity in clinical research. Representativeness in Pragmatic Clinical Trials,” was published online ahead of print in JAMA.

Trials 314
article thumbnail

March 12, 2025: In This Week’s PCT Grand Rounds, Spillover as a Potential Source of Bias in Pragmatic Trials

Rethinking Clinical Trials

Sean Mann In this Friday’s PCT Grand Rounds, Sean Mann of RAND will present “Spillover Due to Constraints on Care Delivery: A Potential Source of Bias in Pragmatic Clinical Trials.” ” The Grand Rounds session will be held on Friday, March 14, 2025, at 1:00 pm eastern. Mann is a senior policy analyst at RAND.

Trials 276
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

November 25, 2024: NIH Collaboratory Trial Investigators Share Lessons From Using Electronic Health Records in Pragmatic Trials

Rethinking Clinical Trials

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.

Trials 146
article thumbnail

India takes centre-stage in clinical trials for HIV/AIDS drug

AuroBlog - Aurous Healthcare Clinical Trials blog

India has taken centre-stage in clinical trials for HIV/AIDS drug as there are several ongoing clinical trials in India focused on advancing HIV treatment. These trials are investigating new drug candidates, therapies, and approaches to manage HIV more effectively and potentially cure it.

article thumbnail

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management.

article thumbnail

December 2, 2024: NCI-Supported LungSMART Trial Joins the NIH Pragmatic Trials Collaboratory

Rethinking Clinical Trials

David Wetter, Guilherme Del Fiol, and Ken Kawamoto, principal investigators for LungSMART The NIH Pragmatic Trials Collaboratory is pleased to welcome LungSMART (Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers) to its portfolio of innovative NIH Collaboratory Trials.

Trials 146
article thumbnail

March 10, 2025: Developing Monitoring Plans Warrants Special Attention in Pragmatic Clinical Trials

Rethinking Clinical Trials

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.

article thumbnail

The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

article thumbnail

Commercial Drug Sourcing for Clinical Trials

The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors successfully navigate these challenges.

article thumbnail

The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays.

article thumbnail

Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies.

article thumbnail

Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan.

article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials.

article thumbnail

Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial.

article thumbnail

Running Decentralized Trials at Scale: Planning for Success

There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Most trials won’t be fully virtual, but all trials will be more virtual.