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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.
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?
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.
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.
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.
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.
enrollment of women in medical schools had just climbed to 20%, it is notable that the chronicles of the Association of ClinicalResearch Professionals (ACRP) describe the first meeting of two nurses who were among the field’s earliest clinicalresearch coordinators, Sarah Boyer and Anne LeSher, as the impetus for the formation of the Association.
Planning on running clinicaltrials in Japan? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. How can you reliably supply these studies?
Click here Research + Font Resize – ICMR to hold workshop on measuring oxidative stress in pre-clinical mouse models to boost […] Home Editorial Services Interview Q&A Chronicle Specials Pharma Mart ePharmail Archives Join Pharma | Login Home > TopNews you can get e-magazine links on WhatsApp.
Clinicalresearch is a vital driver of medical progress. Yet, many people are unaware of the essential role of institutional review boards (IRBs) in protecting clinicaltrial participants by ensuring compliance with human subject protection requirements. It is the foundation of medical innovation.
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? View complete schedule.
says David Vulcano, LCSW, MBA, CIP, RAC, FACRP , Vice President, ClinicalResearch Compliance and Integrity, at HCA Healthcare and author of a recent ACRP White Paper on Responsible Oversight of Artificial Intelligence for ClinicalResearch Professionals. in April.
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.
Decentralized clinicaltrials (DCTs) bring many benefits to the clinicalresearch process, and more importantly, the patients. However, it is important to remember the risks if there is no data security process in place.
This variability not only poses challenges for diagnosis but also stresses the need for targeted research and innovative therapeutic approaches. By exploring rare diseases and focusing on HPP, we can better understand the complexities of genetic disorders and the need for patient-centric research and collaboration.
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.
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 […]
Trends in Psoriasis Research: Biologics, Biosimilars and New Therapies Recent innovations in biologics and biosimilars have transformed psoriasis care. In August 2024, Artax Biopharma completed patient recruitment for its Phase IIa trial of AX-158, exploring a new immune-modulating therapy for psoriasis.
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.
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
In the fast-evolving field of clinicalresearch, thought leaders do more than just keep up; they lead the charge and shape the direction of the industry. Heres how thought leaders are currently making an impact in clinicalresearch: 1.
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.
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.
Lindsell is professor and cochief of biostatistics and bioinformatics, director of data science and biostatistics at the Duke ClinicalResearch Institute, and director of biostatistics and bioinformatics at the Duke Clinical and Translational Science Instituteall at Duke University. Join the online meeting.
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 […]
Syros Pharmaceuticals announced that its cancer drug tamibarotene failed to meet its primary endpoint in the SELECT-MDS-1 Phase III trial. The placebo-controlled SELECT-MDS-1 trial involved 190 patients with complete response rate (CRR) being the study’s primary endpoint. percent and 18.8
Rosa Gonzalez-Guarda The NIH Pragmatic Trials Collaboratory’s Health Equity Core developed a written aid to offer guidance on inclusive language and terms to use when referring to specific people, groups, and communities. View the Equitable Language Cheat Sheet.
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.
2024 has been a year of growth and evolution in clinicalresearch. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinicalresearch, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.
In the trial, platelet response, defined as achieving at least 50,000 platelets per microliter or doubling baseline counts, was seen in 65 percent of patients on rilzabrutinib, compared to 33 percent on placebo. Participants received either rilzabrutinib or placebo for 24 weeks, followed by an open-label extension.
The clinicalresearch industry plays a vital role in advancing medical knowledge and improving healthcare; however, the increasing complexity of clinicaltrials has created a perfect storm of challenges for clinicalresearch sites, posing significant risks to the efficiency, effectiveness, and sustainability of clinicaltrials at large.
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).
The Indian Council of Medical Research (ICMR) has announced a Request for Expressions of Interest (EoI) aimed at inviting researchers, academicians, and scientists to participate in the formulation of evidence-based guidelines for the empirical use of antibiotics in the management of sepsis, dental infections, and vaginal discharge.
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.
Aimed at driving innovation and progress in the field of microbiology, the Indian Pharmacopoeia Commission (IPC) and the CSIR-Institute of Microbial Technology (IMTech), Chandigarh, have joined forces towards advancing microbiological research and development for the betterment of public health.
The Indian Institute of Science (IISc) and Blockchain For Impact (BFI) have teamed up to maximise translational research projects where the latter aims to allocate US$1 million. The collaboration, under the BFI-Biome Virtual Network Programme, will see BFI to support various research projects at the IISc.
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 […]
Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinicaltrials.
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. This distrust is further compounded by a lack of visible accountability and representation in the research process.
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