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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.
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.
Decentralized clinicaltrials (DCTs) bring many benefits to the clinical research process, and more importantly, the patients. However, it is important to remember the risks if there is no data security process in place.
The clinicaltrials industry is facing a number of hurdles, but AI and digitalisation are being heralded as key to overcoming them, particularly when it comes to preparing for inspections and audits
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.
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 […]
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.
Biotech stocks ended 2021 in a slump. But positive results from eagerly anticipated studies in breast cancer, schizophrenia and Alzheimer's disease could help turn the sector's fortunes around.
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.
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.
By the end of June, highly anticipated study results are expected in Alzheimer’s, obesity and Huntington’s disease, while a pair of high-priced acquisitions could be put to the test.
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.
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.
The biotech industry's downturn accelerated in the first half of the year. Important study readouts for Eisai, Gilead, Merck and Seagen, among others, could determine whether the slump will endure.
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.
Planning on running clinicaltrials in Japan? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. How can you reliably supply these studies?
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 a JAMA Viewpoint published online this week , coauthors Adrian Hernandez and Chris Lindsell caution that, although the use of decentralized trials creates meaningful efficiencies, there are major threats to the validity of these trials not captured by traditional monitoring and oversight practices.
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.
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.
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.
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.
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.
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.
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 […]
Bringing more diversity to clinicaltrials is a slow process and it takes time to get right. Learn how Worldwide ClinicalTrials can diversify the reach of your orphan drug trial.
In this Friday's PCT Grand Rounds, Rui Wang of Harvard Medical School will offer the final session in our special series, Advances in the Design and Analysis of Pragmatic ClinicalTrials, with "Methods for Handling Missing Data in Cluster Randomized Trials." The session will be held on Friday, January 5, at 1:00 pm eastern.
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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