This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
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 clinicalresearch. appeared first on Rethinking ClinicalTrials. ” Read the full article.
India has taken centre-stage in clinicaltrials for HIV/AIDS drug as there are several ongoing clinicaltrials 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.
. “AJ” Blood of Harvard Medical School and Brigham and Women’s Hospital will present “Generative Artificial Intelligence in ClinicalTrials: A Driver of Efficiency and Democratization of Care.” ” The Grand Rounds session will be held on Friday, March 21, 2025, at 1:00 pm eastern.
Its becoming more expensive and time-consuming to move a drug from the clinicaltrial stage to approval. Patient recruitment is the leading driver of costs in clinicaltrials, and 55% of trials that fail to complete cite low accrual rate as the reason for study termination.
Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health
AI is transforming clinicaltrials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinicaltrial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes.
Clinicaltrials 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?
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 clinicaltrials, even for trials deemed to have minimal risk.
In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists explores the ethical obligation to share aggregate results from pragmatic clinicaltrials with research participants. The article was published online ahead of print in ClinicalTrials.
Despite advancements in neuroscience and psychiatry, clinicaltrials 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.
This new white paper defines and details the impact of Decentralized ClinicalTrials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Researchers applied the “target trial emulation framework” to highlight important design considerations for observational studies that use real-world data to emulate randomized clinicaltrials. Learn more about the NIH Collaboratory’s Distributed Research Network. Read the full report.
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 clinicaltrials should be incorporated into healthcare delivery processes. Read the full article.
Drawing on experiences from the NIH Collaboratory Trials, authors of a new article in Contemporary ClinicalTrials describe the challenges they encountered when relying on data from the electronic health record (EHR) to monitor outcomes and deliver interventions in pragmatic clinicaltrials embedded in healthcare systems.
Global rare disease clinicaltrials face unique challenges due to small patient populations, complex logistics, diverse regulatory environments and cultural differences. ClinicalTrial Manager/Sr. These measures enhance recruitment, retention and overall trial success.
A large clinicaltrial 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 […]
The surge in MASH cases stresses the need for early diagnosis, timely intervention and precise, reliable methodologies in clinicaltrials to evaluate new therapies effectively. Read on to gain insights from Medpace experts about advancements in imaging, histology and innovative techniques for MASH clinicaltrials.
Over the past two decades, industry-sponsored clinicaltrials have targeted treatments for BPD, yielding some promising outcomes; however, broader psychiatric research often excludes BPD patients, a trend that extends to the emerging field of psychedelic studies.
Clinicalresearch 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.
The NIH Pragmatic Trials Collaboratory will hold a virtual workshop on February 5 and 6, 2025, on Digging Into Dilemmas of Pragmatic ClinicalTrials. The panels will include seasoned investigators and experts in conducting research embedded in healthcare systems from the NIH Collaboratory and beyond.
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 ClinicalTrial.” ” The Grand Rounds session will be held on Friday, November 22, 2024, at 1:00 pm eastern.
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 clinicaltrial methods. These conditions are fairly common in pragmatic trials. In many pragmatic trials, spillover is likely negligible.
Clinicaltrial companies see immense relevance on US FDA Electronic Submission Safety Reports. The guidance provides instructions about how the individual case safety reports (ICSRs) from investigational new drug (IND) need to be supported with Adverse Event Reporting System (AERS).
Planning on running clinicaltrials in Japan? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. How can you reliably supply these studies?
In a recent webinar, Challenges of Drug Development in Early Parkinsons Disease , Tom Babic, MD, PhD , our Vice President of Scientific Solutions in Neuroscience, uses his 40+ years of experience to share invaluable insights into the current state and future directions of early Parkinsons disease (PD) research.
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.
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide ClinicalTrials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
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 clinicaltrials. Learn more about the Ethics and Regulatory Core.
The research team looked at the comparative effectiveness of HBPTM alone versus HBPTM plus telephone-based NCM when administered to Black and Hispanic stroke survivors with uncontrolled hypertension. The research team found that both groups experienced significant SBP reduction at both the six-month and 12-month mark.
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 ClinicalTrials? Morain, PhD, MPH *This session includes case study presentations.
Early Phase Unit, Worldwide ClinicalTrials 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 clinicaltrials in ALS.
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide ClinicalTrials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
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.
A new publication from the FDA Oncology Center of Excellence (OCE) and the ClinicalTrials Transformation Initiative (CTTI), published in the Clinical Cancer Research journal, provides important insights into how decentralized clinicaltrial (DCT) elements were used in cancer trials leading to FDA approval during the COVID-19 pandemic.
In a new article from the NIH Pragmatic Trials Collaboratory, investigators from 6 of the program’s pragmatic clinicaltrials share case examples of the challenges they encountered in collecting patient-reported outcomes (PROs) in their trials and the strategies they used to address them.
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.
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.
Researchers analyzed the electronic health records of more than 18,000 US patients between May 2022 and September 2023 to compare outcomes among those receiving the two injected medicines, and published the […]
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.
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.
In clinicalresearch, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinicaltrial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinicaltrial designs.
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 clinicaltrial. In the Phase I trial, 12 participants received the therapy and were observed for two years. As of 2023, there were approximately 2.7
We organize all of the trending information in your field so you don't have to. Join 21,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content