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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?
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. Sylvester and her colleagues at Medpace—Jennifer Brown, Sr.
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 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.
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.
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.
Eisai and the National Cancer Center have signed an agreement to partner on investigator-initiated clinicalresearch for the anti-cancer agent, tazemetostat (Tazverik Tablets 200 mg), based on the Patient-Proposed Healthcare Services system.
The Indian Council of Medical Research (ICMR) and Panacea Biotec have announced the initiation of the first-ever phase 3 clinicaltrial for a dengue vaccine in India. The trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec.
Velocity ClinicalResearch, the leading multi-specialty clinicalresearch organization, has partnered with Verified ClinicalTrials (VCT) to set a new benchmark for patient safety and data quality in clinicaltrials through a new technological implementation at Velocitys 80+ global sites.
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 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.
It’s even being used to review investigator invoices and automate financial reconciliations—a monthly headache every contract research organization, sponsor, and clinicaltrials operator will be more than happy to resign to machines. Integrating AI tools into complex workflows will require time and understanding.
The recent regulatory developments to relax clinicaltrial norms in India are poised to have a significant impact on the pharmaceutical industry and drug pricing. By easing regulations, Indian pharma could see a reduction in the costs associated with human 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.
Food and Drug Administration (FDA) is highly supportive of clinicaltrial innovation, including advancing study design, conduct, and reporting within the global ecosystem. A key question is what kind of behavior changes can help us improve as clinicalresearch professionals? To succeed, we must overcome our fears.
Following the success of Issue 3 , which focused on the critical importance of patient diversity in clinicalresearch, Xtalks is thrilled to announce Xtalks Clinical Edge Issue 4. These prominent leaders will share their experiences, strategies and visions about whats next for clinicalresearch.
In this episode, Vera spoke with Morgan Hanger, Executive Director of the ClinicalTrials Transformation Initiative (CTTI). CTTI is a public-private partnership dedicated to improving the quality and efficiency of clinicaltrials, with an ambitious “Transforming Trials 2030” vision.
The NIH Pragmatic Trials Collaboratory’s Health Equity Core released a new Health Equity in Pragmatic ClinicalTrials guide designed to help research teams define health equity and provide examples of how to promote it in clinicalresearch. ” View the complete guide. .
But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinicaltrials. Pharma R&D teams are solving this problem by leveraging the power of artificial intelligence (AI) in clinicaltrials to save time and money.
Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinicalresearch, and how did you enter the field? So I’ve been working in that space about 43 years.
In the increasingly advancing world of medicine, personalized care is a key factor that can progress your drug development efforts. One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinicaltrial. Reduces Trial Failures Oftentimes, clinicaltrials may fail due to a lack of efficacy.
Speaking at the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting in May, Commissioner of Food and Drugs Robert Califf and NIH Director Monica Bertagnolli discussed the intersection of pragmatic research and national health priorities. However, several barriers hinder the development of such a system.
Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinicalresearch. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinicaltrials, which judiciously test and evaluate safety and efficacy.
Over the past decade, Germany’s share of global clinicaltrial activities has dropped year on year. of trials in 2021 , down from 7.2% Aiming to revitalize the country’s pharmaceutical industry, it signaled a shift from policymakers on clinicalresearch and drug development issues.
Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinicaltrials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.
Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. Our consultative approach ensures success by integrating research methodology, regulatory affairs strategy, and clinical operations. You have the oversight you need.
With nothing more than a drop of blood, medical specialists could soon have years of advance warning that the disease is developing. As treatments for multiple sclerosis (MS) continue to improve, scientists are looking for ways to spot the condition before symptoms set in. MS affects nearly a million people in the US alone, whose […]
Despite these advancements, challenges for widespread effective care remain due to the heterogeneous patient population, opening the door for further development of treatments for T2D. Obesity is a major factor in the prevalence of T2D, and it is vital to develop T2D treatments with this in mind.
Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).
Along with a team of nurses and other stakeholders, the PI will conduct the trial at his/her study site. However, the sponsor will remain the monitor of the trial. The next figure shows the important stakeholders in a clinicaltrial. Traditionally, clinicaltrials have never been designed with patient-centricity in mind.
This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinicaltrial regulation in the UK with expedited timelines at several stages. The MHRA hopes this new framework “will remove obstacles to innovation” and “streamline the regulation of clinicaltrials” amongst other things.
COVID sent us into a series of lockdowns in a bid to control the spread of the virus until a vaccine could be developed. The world changed for all of us when we were suddenly plunged into a pandemic in 2020. Most of us knew that a vaccine would be the key to our post-pandemic […]
As one of the more recent fields to emerge in the clinical space, psychedelics have gained significant traction as a potential treatment for various neuropsychiatric diseases. Psychedelic Research at Worldwide Since 2017, Worldwide ClinicalTrials have supported a myriad of sponsors leading the way in psychedelic research programs.
Medidata, part of Dassault Systèmes, has partnered with Lambda Therapeutics to automate and consolidate data management processes for improved clinicaltrial efficiency. Rave RTSM, which has been developed on Rave EDC, eliminates double data entry and requires reduced reconciliation that speeds up study start-up and close-out.
In clinicalresearch, this includes designing trials that elevate the patient voice, reduce barriers to participation, and represent the diverse populations who will ultimately use these medical products. Access to information: Limited resources and educational materials hinder informed decision-making about trial participation.
RECOVER has used cohort data to identify major symptom clusters and develop 5 platform protocols that will investigator priority symptom clusters and their causes; test known and novel interventions across domains; and evaluate treatments to improve Long COVID symptoms. It’s all over the place.
Clinicaltrials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols.
Clinicaltrials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols.
Clinicaltrials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols.
Clinicaltrials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols.
Learn how clinicalresearchers are embracing open data and tools to overhaul the drug development process. Think open-source is just for software? Think again.
She celebrates how healthcare professionals have an exceptional power to transform lives, and will share her perspective on how compassionate care can be incorporated into clinicalresearch in a Signature Series keynote session tailored for attendees of ACRP 2025 in New Orleans, La., in April. I wanted to feel peaceful.
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