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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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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XTalks

OCTOBER 22, 2024

Given these dire statistics, the need for innovative approaches in obesity clinical trials 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.

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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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Worldwide Clinical Trials

MAY 10, 2024

Over the past two decades, industry-sponsored clinical trials 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.

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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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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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Rethinking Clinical Trials

MARCH 4, 2025

Researchers with PRIM-ER, an NIH Collaboratory Trial, published 2 innovative statistical techniques for evaluating intervention effects in stepped-wedge, cluster randomized trials. The researchers applied both models to data from PRIM-ER. The article was published online in Statistics in Medicine. Read the full report.

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Worldwide Clinical Trials

APRIL 7, 2025

Solid tumors present a significant challenge to clinical research due to their complex and heterogeneous nature. Have you optimized your trial designs to employ precision medicine approaches for your novel solid tumor intervention?

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XTalks

APRIL 8, 2025

Nate Lear Head, Advanced Analytics and Clinical Trial Efficiency AstraZeneca Recent advances in AI are ushering in a new era for cancer care. AI is transforming screening, drug discovery and clinical decision support. This speeds up protocol development and allows for real-time adjustments based on evolving needs.

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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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AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 13, 2025

The measures should also include […]

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 16, 2024

Under […]

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Pharmaceutical Technology

NOVEMBER 8, 2022

Cyagen and Neurophth Therapeutics have entered a strategic partnership to jointly develop next-generation AAV gene therapy vectors for specific kinds of genetic ophthalmic ailments. Additionally, Neurophth will oversee the clinical trials and marketing of gene therapy products developed leveraging the new AAV capsids of Cyagen.

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 22, 2024

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.

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World of DTC Marketing

DECEMBER 29, 2020

OBSERVATION: Biologics can take a long time to develop but COVID vaccines have been in development for almost 50 years and novel approaches were used to develop these vaccines. Vaccines typically take 10 to 15 years to develop, test and release to the public. The post How did pharma develop a vaccine so quickly?

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ACRP blog

OCTOBER 10, 2024

It’s even being used to review investigator invoices and automate financial reconciliations—a monthly headache every contract research organization, sponsor, and clinical trials operator will be more than happy to resign to machines. Integrating AI tools into complex workflows will require time and understanding.

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Rethinking Clinical Trials

JANUARY 9, 2025

The NIH Pragmatic Trials Collaboratory will hold a virtual workshop on February 5 and 6, 2025, on Digging Into Dilemmas of Pragmatic Clinical Trials. The panels will include seasoned investigators and experts in conducting research embedded in healthcare systems from the NIH Collaboratory and beyond.

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Rethinking Clinical Trials

NOVEMBER 14, 2024

The Interagency Pain Research Coordinating Committee (IPRCC) is accepting nominati ons for new members to help advance the diagnosis, prevention, and treatment of pain and diseases and disorders associated with pain. View the IPRCC Member Nomination Form. For more information, contact Leah Pogorzala leah.pogorzala@nih.gov.

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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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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 25, 2024

The recent regulatory developments to relax clinical trial 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.

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Pharmaceutical Technology

APRIL 10, 2023

Aviceda Therapeutics (Aviceda) has entered into a strategic partnership with the Patrick G Johnston Centre for Cancer Research at Queen’s University Belfast (QUB) for the development of next-generation glyco-immune therapeutics. The company strengthens the translational research collaboration between the US and Ireland.

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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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Pharmaceutical Technology

OCTOBER 14, 2022

German pharmaceutical firm Merck has extended its partnership with Moderna to jointly develop and sell mRNA-4157/V940, an investigational personalised cancer vaccine (PCV). In 2016, the companies entered a strategic partnership to develop novel messenger RNA (mRNA) based PCVs.

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Pharmaceutical Technology

NOVEMBER 22, 2022

Umoja Biopharma has signed a research agreement with IASO Biotherapeutics (IASO Bio) to develop off-the-shelf therapies for haematological malignancies. The post Umoja and IASO partner to develop therapies for haematological malignancies appeared first on Pharmaceutical Technology.

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Rethinking Clinical Trials

OCTOBER 12, 2023

In a new article published this week in Contemporary Clinical Trials Communications, the GRACE Demonstration Project team recommends that suicidality should be monitored in pragmatic clinical trials that measure depression as an outcome. Learn more about the GRACE trial.

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Worldwide Clinical Trials

DECEMBER 7, 2023

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. What Differentiates Mid-Size CROs?

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Pharmaceutical Technology

OCTOBER 25, 2022

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.

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Worldwide Clinical Trials

JANUARY 6, 2025

Tom Zhang, PhD, Chief Scientific Officer, Large Molecule Bioanalysis Revolutionizing Therapeutic Development with Cutting-Edge Bioanalysis Automation Cutting-edge advancements in bioanalysis (BioA) and drug R&D are reshaping the future of preventative and interventional care, but how do we harness these to their fullest potential?

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Pharmaceutical Technology

APRIL 3, 2023

Eisai and the National Cancer Center have signed an agreement to partner on investigator-initiated clinical research for the anti-cancer agent, tazemetostat (Tazverik Tablets 200 mg), based on the Patient-Proposed Healthcare Services system.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 12, 2023

Researchers have developed a blood test to determine a person’s risk of developing anxiety, while also providing insight into its current severity and best course of treatment.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 6, 2024

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.

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Rethinking Clinical Trials

SEPTEMBER 30, 2024

The NIH Pragmatic Trials Collaboratory’s Health Equity Core released a new Health Equity in Pragmatic Clinical Trials guide designed to help research teams define health equity and provide examples of how to promote it in clinical research. ” View the complete guide. .

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Rethinking Clinical Trials

FEBRUARY 4, 2025

A workshop summary, videocast recordings, and other materials are now available from the NIH Pragmatic Trials Collaboratory’s 2024 virtual workshop, “Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues.

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XTalks

NOVEMBER 12, 2024

November is Pancreatic Cancer Awareness Month , a time dedicated to increasing public understanding of this challenging disease, supporting patients and their families and advancing research for better treatment options. For this reason, researchers are working hard to find new methods to identify pancreatic cancer sooner.

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FDA Law Blog

NOVEMBER 10, 2024

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 clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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Worldwide Clinical Trials

JANUARY 21, 2025

Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. What is one contributing factor that sets the 20% that do apart from the rest?

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