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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.
The Central Drugs Standard Control Organisation (CDSCO) has sought the industry to start submitting the applications for clinicaltrial site addition and change of principal investigator through online mode, as part of streamlining the regulatory submission procedure.
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 ClinicalTrials,” was published online ahead of print in JAMA.
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.
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.
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?
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 ClinicalTrials.” ” 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.
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.
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.
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.
Given these dire statistics, the need for innovative approaches in obesity clinicaltrials has never been more urgent. These trials are crucial for understanding and managing obesity while improving strategies to combat this complex health issue. Methods for endpoint protection in obesity 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 […]
The global landscape of clinicaltrials 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.
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.
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.
One key aspect of this journey is the clinicaltrial design and execution process a critical step that can make or break the success of a biosimilar product. When it comes to designing clinicaltrials for biosimilars, there are several key considerations to keep in mind. Share your insights in the comments below!
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.
Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinicaltrials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined 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.
This was a multisite, practice-based, comparative effectiveness randomized clinicaltrial conducted at six public hospitals and three academic medical centers in New York City. They measured within-patient change in systolic blood pressure (SBP) from baseline to 12 months and the rate of recurrent stroke at 24 months.
Study results are expected for a pair of closely watched obesity drugs, while key tests await for a high-priced AbbVie acquisition and one of 2023’s largest IPOs.
A non-addictive pain pill faces its definitive test, while study results in ALS, a rare heart disease and lung cancer could have far-reaching implications.
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 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.
People with missing teeth may be able to grow new ones, say Japanese dentists testing a pioneering drug they hope will offer an alternative to dentures and implants. Unlike reptiles and fish, which usually replace their fangs on a regular basis, it is widely accepted that humans and most other mammals only grow two sets […]
Patients taking Eli Lilly’s new drug Mounjaro achieved significantly greater weight loss than those on Novo Nordisk’s Ozempic, a head-to-head study published Monday showed.
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 clinicaltrials.
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.
Expected readouts in diabetes, cancer and depression headline a series of study results that could help the biotechnology sector regain its footing after a shaky year.
There’s been a rapid shift towards decentralization in clinicaltrials & 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.
The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinicaltrials, has recommended grant of market authorisation for Telangana-based MSN Laboratories for sleep disorder drug Pitolisant tablets.
By integrating the best practices from decentralized trials, CROs can optimize efficiencies and streamline site-based operations, ensuring that site-centric trials remain effective and innovative.
Gbenga Ogedegbe In this Friday’s PCT Grand Rounds, Gbenga Ogedegbe of the NYU Grossman School of Medicine will present “Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized ClinicalTrial.”
The Union health ministry has issued final notification defining the clinical research 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 […]
While China has become a key country for global clinicaltrials, navigating regulatory complexities and ensuring data integrity requires expertise and in-country support services.
The NIH Pragmatic Trials Collaboratory will hold a virtual workshop on February 5 and 6, 2025, on Digging Into Dilemmas of Pragmatic ClinicalTrials. Recordings and materials will be archived on the NIH Pragmatic Trials Collaboratory’s website at rethinkingclinicaltrials.org.
The sourcing of commercial drugs for use in clinicaltrials 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.
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