XTalks

DECEMBER 19, 2024

Despite advancements in neuroscience and psychiatry, clinical trials 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.

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Clinical Trials Clinical Trials Trials Research 97

XTalks

APRIL 8, 2025

Global rare disease clinical trials face unique challenges due to small patient populations, complex logistics, diverse regulatory environments and cultural differences. Clinical Trial Manager/Sr. These measures enhance recruitment, retention and overall trial success.

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Clinical Trials Clinical Trials Trials Gene Therapy 88

Bio Pharma Dive

AUGUST 29, 2022

With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area.

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Clinical Trials Clinical Trials Clinical Research Regulation 326

ACRP blog

OCTOBER 30, 2024

enrollment of women in medical schools had just climbed to 20%, it is notable that the chronicles of the Association of Clinical Research Professionals (ACRP) describe the first meeting of two nurses who were among the field’s earliest clinical research coordinators, Sarah Boyer and Anne LeSher, as the impetus for the formation of the Association.

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Clinical Research Research Nurses Clinical Research Coordinator 64

Advarra

MARCH 7, 2025

Clinical research is a vital driver of medical progress. Yet, many people are unaware of the essential role of institutional review boards (IRBs) in protecting clinical trial participants by ensuring compliance with human subject protection requirements. It is the foundation of medical innovation.

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Clinical Research Research Clinical Trials Clinical Trials 52

XTalks

JANUARY 16, 2025

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 clinical trial. In the Phase I trial, 12 participants received the therapy and were observed for two years. As of 2023, there were approximately 2.7

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Trials Clinical Trials Clinical Trials Gene Therapy 105

ACRP blog

JANUARY 14, 2025

Food and Drug Administration (FDA) is highly supportive of clinical trial 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 clinical research professionals? To succeed, we must overcome our fears.

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Clinical Research Research Clinical Trials Clinical Trials 59

XTalks

DECEMBER 10, 2024

The surge in MASH cases stresses the need for early diagnosis, timely intervention and precise, reliable methodologies in clinical trials to evaluate new therapies effectively. Read on to gain insights from Medpace experts about advancements in imaging, histology and innovative techniques for MASH clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 106

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 14, 2024

A large clinical trial 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 […]

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Clinical Trials Clinical Trials Trials Drugs 246

ACRP blog

MARCH 18, 2025

says David Vulcano, LCSW, MBA, CIP, RAC, FACRP , Vice President, Clinical Research Compliance and Integrity, at HCA Healthcare and author of a recent ACRP White Paper on Responsible Oversight of Artificial Intelligence for Clinical Research Professionals. in April.

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Clinical Research Research Compliance Clinical Trials 69

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 29, 2024

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 Clinical Trials Rules (NDCTR), 2019. The New Drugs and Clinical Trials (Amendment) Rules, 2024, notified on September […]

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Clinical Trials Clinical Trials Clinical Research Trials 246

XTalks

NOVEMBER 15, 2024

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

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Trials HR Immune Response FDA Approval 105

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 18, 2024

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.

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Clinical Research Research Clinical Trials Clinical Trials 245

XTalks

APRIL 17, 2025

Their discussion shows how meaningful partnerships, deep listening and unwavering patient-centricity can transform clinical research, trial design and care delivery in rare conditions such as HPP. Early collaborations in clinical trial design enabled both teams to integrate critical patient insights into study protocols.

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Clinical Research Research Clinical Trials Clinical Trials 52

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 29, 2024

Clinical trial 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).

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Clinical Trials Clinical Trials Trials Drugs 240

Rethinking Clinical Trials

JANUARY 15, 2025

Lindsell is professor and cochief of biostatistics and bioinformatics, director of data science and biostatistics at the Duke Clinical Research Institute, and director of biostatistics and bioinformatics at the Duke Clinical and Translational Science Instituteall at Duke University. Join the online meeting.

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Bioinformatics Clinical Trials Clinical Trials Clinical Research 173

Bio Pharma Dive

OCTOBER 14, 2024

Learn how the right NGS technology can enhance clinical research while supporting downstream efforts toward global commercialization.

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Clinical Trials Clinical Trials Clinical Research Trials 242

XTalks

DECEMBER 10, 2024

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.

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Trials Protein Clinical Development Drugs 104

Velocity Clinical Research

JANUARY 30, 2025

Velocity Clinical Research, the leading multi-specialty clinical research organization, has partnered with Verified Clinical Trials (VCT) to set a new benchmark for patient safety and data quality in clinical trials through a new technological implementation at Velocitys 80+ global sites.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Rethinking Clinical Trials

MARCH 28, 2024

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.

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Trials Nurses Clinical Trials Clinical Trials 219

Worldwide Clinical Trials

AUGUST 9, 2024

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 clinical trials.

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Trials Clinical Trials Clinical Trials Regulation 200

Rethinking Clinical Trials

NOVEMBER 4, 2024

The NIH and the Patient-Centered Outcomes Research Institute (PCORI) are major funders of pragmatic clinical trials embedded in healthcare systems. An existing chapter of the Living Textbook of Pragmatic Clinical Trials provided guidance on how to Develop a Compelling Grant Application for the NIH.

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Development Clinical Trials Clinical Trials Trials 145

ACRP blog

OCTOBER 22, 2024

The clinical research industry plays a vital role in advancing medical knowledge and improving healthcare; however, the increasing complexity of clinical trials has created a perfect storm of challenges for clinical research sites, posing significant risks to the efficiency, effectiveness, and sustainability of clinical trials at large.

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Trials Clinical Research Clinical Trials Clinical Trials 59

Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

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Research Clinical Trials Clinical Trials Immune Response 147

Worldwide Clinical Trials

APRIL 8, 2025

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.

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Research Clinical Trials Clinical Trials Trials 124

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 19, 2024

The Indian Council of Medical Research (ICMR) and Panacea Biotec have announced the initiation of the first-ever phase 3 clinical trial for a dengue vaccine in India. The trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec.

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Clinical Trials Clinical Trials Vaccine Vaccination 189

XTalks

MARCH 26, 2025

In the fast-evolving field of clinical research, 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 clinical research: 1.

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Clinical Research Research Branding Clinical Trials 52

XTalks

NOVEMBER 19, 2024

In clinical research, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinical trial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinical trial designs.

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Clinical Trials Clinical Trials Trials Production 65

XTalks

APRIL 25, 2025

This week, LEO Pharma announced the publication of pivotal Phase III clinical trial results in The Lancet for its topical delgocitinib cream to treat severe chronic hand eczema (CHE). Results from the trial showed delgocitinib to have superior efficacy and safety over oral alitretinoin, the current standard of care for CHE.

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Trials Dermatology Clinical Trials Clinical Trials 59

Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

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Research Clinical Trials Clinical Trials Immune Response 130

Advarra

DECEMBER 17, 2024

2024 has been a year of growth and evolution in clinical research. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.

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Clinical Research Research Trials Clinical Trials 98

Velocity Clinical Research

APRIL 7, 2025

Velocity is collaborating with Merck to enhance the way trial insights are shared within Merck and across Velocity sites worldwide. This collaboration marks another significant step toward improving clinical trials for participants, Sponsors, and sites worldwide.

Trials 52

Trials Clinical Trials Clinical Trials Clinical Research 52

XTalks

DECEMBER 12, 2024

In clinical research, 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.

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Clinical Trials Clinical Trials Clinical Research Trials 59