Clinical Research - Clinical Research Informer

The Growing Trend of Patient-Led Clinical Research in Rare Disease

Worldwide Clinical Trials

OCTOBER 29, 2024

By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?

Clinical Research

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Why prospective real-world studies hold so much promise for clinical research

Bio Pharma Dive

OCTOBER 30, 2023

PrwS studies can reach beyond the limitations of today’s RWE studies and expand the role of RWD across the entire drug development cycle.

Clinical Research

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ICMR to hold workshop on measuring oxidative stress in pre-clinical mouse models to boost pre-clinical research

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.

Clinical Research

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Psychedelic clinical trials: What sponsors should know when designing new protocols

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.

Clinical Trials

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

Clinical Trials

Gilead adds investigational HIV vaccine to its portfolio from Spanish biotech

Pharmaceutical Technology

NOVEMBER 26, 2024

Gilead and Aelix first teamed up in 2018 for a clinical research collaboration agreement to investigate the vaccine.

Vaccination

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Health ministry notifies Rules to register CROs under NDCTR, 2019

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 […]

Clinical Trials

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Data sharing will be key in repairing the UK clinical ecosystem

Pharmaceutical Technology

JUNE 12, 2024

Lord James O'Shaughnessy, the former health minister, outlines places where the UK is falling behind other countries with clinical research.

Clinical Research

Clinical Research Research

From maximizing recruitment to promoting diversity: How to deploy NGS technologies to achieve clinical trial success

Bio Pharma Dive

OCTOBER 14, 2024

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

Clinical Trials

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? This new guidance will clearly impact the clinical research field, but how? Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinical development?

Clinical Research

Decentralized clinical trials (DCTs): protect your data to reduce risk

Bio Pharma Dive

JUNE 12, 2023

Decentralized clinical trials (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.

Clinical Trials

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Amplifying lupus disease activity with real-world data and machine learning

Bio Pharma Dive

MAY 8, 2023

Real-world data and artificial intelligence are both critical to the future of clinical research. Although there is currently no cure, there is great promise in the fight against lupus.

Clinical Research

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Why high-tech solutions require high-touch service to create value in today’s complex drug development landscape

Bio Pharma Dive

AUGUST 14, 2023

Stephen Apps discusses how technology can help improve the speed and quality of clinical research and why a dedicated, cross-functional approach is needed to maximize its value for smaller biotechs.

Clinical Research

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Ophthalmologists eye gene therapies for vision-threatening conditions as NGS facilitates precision diagnosis

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 9, 2024

The convergence of gene therapies and clinical research is pushing the boundaries of what’s possible in ophthalmic care, offering hope for more effective treatments and potential cures for a range of vision-threatening conditions.

Gene Therapy

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. How can you reliably supply these studies?

Clinical Research

November 21, 2024: Are Pragmatic Trials Living Up to the Promise of Improving Representativeness?

Rethinking Clinical Trials

NOVEMBER 21, 2024

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 Clinical Trials,” was published online ahead of print in JAMA.

Trials

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China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma

Pharmaceutical Technology

MAY 22, 2023

As the world’s first humanised IgG4-κ monoclonal antibody targeting IL-17RB, SM17 has made satisfactory progress in clinical research under the active promotion of the company.

Immune Response

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3 Key Takeaways from Psychedelic Science 2023

Worldwide Clinical Trials

AUGUST 10, 2023

We Have an Opportunity to Improve from Past Experiences The history of clinical research is full of shortcomings, including the unethical treatment of research participants and the exclusion of members of racial and ethnic minority groups and the LGBTQIA+ community.

Clinical Trials

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March 28, 2024: Health Equity Core Provides Reference for Equitable Language in Pragmatic Trials

Rethinking Clinical Trials

MARCH 28, 2024

The cheat sheet includes preferred terminology when referring to the following identities: Age Race and ethnicity Gender Differing abilities Drug/substance abuse People who are underserved, at increased risk, or economically marginalized Partners and populations of focus The Health Equity Core provides direction for pragmatic trials on how to integrate (..)

Trials

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

Clinical Trials

October 1, 2024: NIH CARE for Health Issues Awards to Inaugural Research Network Hubs

Rethinking Clinical Trials

OCTOBER 1, 2024

The NIH Communities Advancing Research Equity for Health , or CARE for Health , program announced 3 inaugural hubs for its primary care–focused clinical research network. These awards are part of a pilot project to test the feasibility of a research network that expands research opportunities to primary care settings.

Research

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September 30, 2024: New Guide From NIH Collaboratory Promotes Health Equity in Pragmatic Clinical Trials

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.

Clinical Trials

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Hospital Universitario and Josep Carreras develop cell therapy for leukaemia

Pharmaceutical Technology

JANUARY 17, 2023

The Joint Cancer Immunotherapy Clinical Research Unit of the Hospital Universitario 12 de Octubre and the Spanish National Cancer Research Center (CNIO) created the STAb-T therapy led by Dr Luis Álvarez-Vallina and the Josep Carreras Leukaemia Research Institute team Dr Pablo Menéndez and Dr Diego Sánchez-Martínez.

Development

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November 4, 2024: Update to Living Textbook Offers Tips for Developing a Compelling PCORI Grant Application

Rethinking Clinical Trials

NOVEMBER 4, 2024

The post November 4, 2024: Update to Living Textbook Offers Tips for Developing a Compelling PCORI Grant Application appeared first on Rethinking Clinical Trials.

Development

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

August 8, 2024: FDA Commissioner and NIH Director Share Thoughts on the Future of Pragmatic Clinical Trials

Rethinking Clinical Trials

AUGUST 8, 2024

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.

Clinical Trials

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Innovation in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

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.

Research

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The Power of Personalization Amid the Changing CRO Landscape

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.

Clinical Development

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Innovating in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

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.

Research

Research Clinical Trials Clinical Trials Immune Response

There’s a Strange Link Between Depression And Body Temperature, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 20, 2024

(VioletaStoimenova/Getty Images) To better treat and prevent depression, we need to understand more about the brains and bodies in which it occurs. Curiously, a handful of studies have identified links between depressive symptoms and body temperature, yet their small sample sizes have left too much room for doubt.

Clinical Trials

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Alzheimer’s Is More Common in Women, And This May Help Explain Why

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 9, 2024

Yet researchers have suspected there could be more to the story. In the US, roughly two out of every three people with Alzheimer’s is a woman, a statistic that could be partially explained by the fact women typically live longer than men. Now two new studies raise the possibility of complex interactions between hormones and […]

Hormones

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The Blood of Exceptionally Long-Lived People Reveals Crucial Differences

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 18, 2024

(Bloomberg Creative/Getty Images) Centenarians, once considered rare, have become commonplace. Indeed, they are the fastest-growing demographic group of the world’s population, with numbers roughly doubling every ten years since the 1970s.

Clinical Trials

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Some Coffee And Tea Drinkers Could Be Lowering Their Risk of Dementia

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 26, 2024

Researchers at Ningxia Medical University in China have found that some coffee or tea drinkers are lowering their risk of dementia. (juanma hache/Getty Images) A new study has investigated whether drinking coffee or tea can reduce the risk of developing dementia, and the findings help explain some murky past results.

Research

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There’s a Surprisingly Simple Way to Remove Microplastics From Your Drinking Water

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2024

Tiny fragments of microplastics are making their way deep inside our bodies in concerning quantities, significantly through our food and drink. Scientists have now found a simple and effective means of removing them from water.

Scientist

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One Diet Choice While Pregnant May Protect Your Child’s Heart For Life

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 31, 2024

The food consumed by a pregnant mother just got a little bit more important. According to a new study on pregnant mice, a diet rich in fiber improves the long-term heart health of developing offspring, significantly lowering their risk of cardiovascular disease later in life.

Development

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Sexually Transmitted Infections Are Rising in Older People, And This May Be Why

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 4, 2024

Diagnoses for sexually transmitted infections, or STIs, are increasing in older adults. The Centers for Disease Control and Prevention reports the number of people older than 65 diagnosed with chlamydia, gonorrhea or syphilis in the U.S. increased about three-, five- and sevenfold, respectively, from 2010 to 2023.

Clinical Trials

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Scientists Destroy 99% of Cancer Cells in Lab With Vibrating Molecules

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 13, 2024

Illustration of a cancer cell. Science Photo Library/Canva Pro) Scientists have discovered a remarkable way to destroy cancer cells. Stimulating aminocyanine molecules with near-infrared light caused them to vibrate in sync, enough to break apart the membranes of cancer cells.

Scientist

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Extreme Case of Man Who Had 217 COVID Vaccines Surprises Scientists

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 12, 2024

Two hundred and seventeen. That’s how many vaccines a man in Germany claims to have received for COVID-19 in just 29 months – and his body isn’t reacting the way some scientists thought it would. The 62-year-old male from the city of Magdeburg made headlines a few years ago for his private and risky decision […]

Scientist

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Expert Reveals What Happens to Your Liver When You Quit Alcohol

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 24, 2024

According to Greek mythology, Zeus punished Prometheus for giving fire to humans. He chained Prometheus up and set an eagle to feast on his liver. Each night, the liver grew back and each day, the eagle returned for his feast. In reality, can a liver really grow back? The liver is the largest internal organ […]

Clinical Trials

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Type 2 Diabetes Drug Linked to 35% Lower Dementia Risk in Patients

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 11, 2024

The researchers compared the health outcomes of more than 110,000 people aged 40–69 with type 2 diabetes who had been prescribed a type of drug called […]

Drugs

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New Alzheimer’s Nasal Spray Clears Toxic Tangles in Human Neurons And Mice

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 15, 2024

Some scientists suspect these neural knots can harm and even kill brain cells, but so far in clinical trials, drugs that have tried to target the tangles have shown limited success. Twisted and tangled proteins are found in the brains of many of those who die with Alzheimer’s disease. A promising new medicine has now […]

Clinical Trials

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Shock Result Reveals The Fruit You May Want to Leave Out of Smoothies

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 4, 2024

Sure, this fruit is full of potassium and makes a drink deliciously thick and creamy, but according to researchers from the University of California Davis (UCD), there’s something in bananas that might overpower the antioxidants in berries. […]

Research

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A Common Sleeping Pill May Reduce Buildup of Alzheimer’s Proteins, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 8, 2024

(Tero Vesalainen/iStock/Getty Images) There’s still so much we don’t know about Alzheimer’s disease, but the link between poor sleep and worsening disease is one that researchers are exploring with gusto.

Protein

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New HIV Prevention Drug Shows 100% Efficacy in Clinical Trial

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. The trial tested whether the six-month injection of lenacapavir would provide better protection against HIV infection than two other drugs, both daily pills.

Clinical Trials

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The Growing Trend of Patient-Led Clinical Research in Rare Disease

Why prospective real-world studies hold so much promise for clinical research

Trending Sources

ICMR to hold workshop on measuring oxidative stress in pre-clinical mouse models to boost pre-clinical research

Psychedelic clinical trials: What sponsors should know when designing new protocols

The New Age of Decentralized Clinical Trials

Gilead adds investigational HIV vaccine to its portfolio from Spanish biotech

Health ministry notifies Rules to register CROs under NDCTR, 2019

Data sharing will be key in repairing the UK clinical ecosystem

From maximizing recruitment to promoting diversity: How to deploy NGS technologies to achieve clinical trial success

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Decentralized clinical trials (DCTs): protect your data to reduce risk

Amplifying lupus disease activity with real-world data and machine learning

Why high-tech solutions require high-touch service to create value in today’s complex drug development landscape

Ophthalmologists eye gene therapies for vision-threatening conditions as NGS facilitates precision diagnosis

Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

November 21, 2024: Are Pragmatic Trials Living Up to the Promise of Improving Representativeness?

China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma

3 Key Takeaways from Psychedelic Science 2023

March 28, 2024: Health Equity Core Provides Reference for Equitable Language in Pragmatic Trials

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

October 1, 2024: NIH CARE for Health Issues Awards to Inaugural Research Network Hubs

September 30, 2024: New Guide From NIH Collaboratory Promotes Health Equity in Pragmatic Clinical Trials

Hospital Universitario and Josep Carreras develop cell therapy for leukaemia

November 4, 2024: Update to Living Textbook Offers Tips for Developing a Compelling PCORI Grant Application

The New Age of Decentralized Clinical Trials

August 8, 2024: FDA Commissioner and NIH Director Share Thoughts on the Future of Pragmatic Clinical Trials

Innovation in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

The Power of Personalization Amid the Changing CRO Landscape

Innovating in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

There’s a Strange Link Between Depression And Body Temperature, Study Finds

Alzheimer’s Is More Common in Women, And This May Help Explain Why

The Blood of Exceptionally Long-Lived People Reveals Crucial Differences

Some Coffee And Tea Drinkers Could Be Lowering Their Risk of Dementia

There’s a Surprisingly Simple Way to Remove Microplastics From Your Drinking Water

One Diet Choice While Pregnant May Protect Your Child’s Heart For Life

Sexually Transmitted Infections Are Rising in Older People, And This May Be Why

Scientists Destroy 99% of Cancer Cells in Lab With Vibrating Molecules

Extreme Case of Man Who Had 217 COVID Vaccines Surprises Scientists

Expert Reveals What Happens to Your Liver When You Quit Alcohol

Type 2 Diabetes Drug Linked to 35% Lower Dementia Risk in Patients

New Alzheimer’s Nasal Spray Clears Toxic Tangles in Human Neurons And Mice

Shock Result Reveals The Fruit You May Want to Leave Out of Smoothies

A Common Sleeping Pill May Reduce Buildup of Alzheimer’s Proteins, Study Finds

New HIV Prevention Drug Shows 100% Efficacy in Clinical Trial

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