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. “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.
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.
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.
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. Finally, psychiatry clinicaltrials must also address the variability in treatment responses.
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.
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.
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.
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.
However, spillover due to resource constraints is absent from the major frameworks that inform clinicaltrial methods. They recently published a paper in Trials that explores the issue in further detail: Mann, S. Negative spillover due to constraints on care delivery: a potential source of bias in pragmatic clinicaltrials.
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 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.
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.
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 […]
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.
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.
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.
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?
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.
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.
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.
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.
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 […]
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.
The workshop introduced concepts in the design, conduct, and implementation of pragmatic clinicaltrials embedded in healthcare systems, with a focus on methods relevant to health services researchers. O'Brien, PhD Session 1: What Are Embedded Pragmatic ClinicalTrials?
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.
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.
The Interagency Pain Research Coordinating Committee (IPRCC) is accepting nominati ons for new members to help advance the diagnosis, prevention, and treatment of pain and diseases and disorders associated with pain. View the IPRCC Member Nomination Form. For more information, contact Leah Pogorzala leah.pogorzala@nih.gov.
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.
Trends in Psoriasis Research: Biologics, Biosimilars and New Therapies Recent innovations in biologics and biosimilars have transformed psoriasis care. The Psoriasis Diet Diet has long been an area of research as a potential factor in managing psoriasis.
The NIH and the Patient-Centered Outcomes Research Institute (PCORI) are major funders of pragmatic clinicaltrials embedded in healthcare systems. An existing chapter of the Living Textbook of Pragmatic ClinicalTrials provided guidance on how to Develop a Compelling Grant Application for the NIH.
The Union health ministry has issued final notification defining the clinicalresearch organisations (CROs) and mandating registration for the organisations to operate under the New Drugs and ClinicalTrials Rules (NDCTR), 2019. The New Drugs and ClinicalTrials (Amendment) Rules, 2024, notified on September […]
Struggling with multi-country clinicaltrials? Introduction Carrying out a multi-country clinicaltrial is indeed an arduous […] The post A True CRO Partner for Your Multi-Country ClinicalTrial appeared first on ProRelix Research.
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 presenters of this seminar have been researching strategies to implement holistic pain management strategies in the Military Health System and evaluating ways to provide pain care that aligns with the DoD/VA Stepped Care Model for Pain Management. Registration is required for participation this live web conference, but there is no cost.
ABATE Infection, an NIH Collaboratory Trial, was a cluster randomized pragmatic trial of universal chlorhexidine bathing and nasal decolonization compared with usual care for more than 500,000 hospitalized patients. Previous research had shown the effectiveness of the intervention in ICUs. Learn more about ABATE Infection.
Sara Singer, principal investigator for iPATH Researchers from iPATH, an NIH Collaboratory Trial, described key considerations for integrating artificial intelligence tools into analyses of qualitative data. The report was posted this month on the AcademyHealth Blog. Read the full report. Learn more about iPATH.
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