Clinical Trials - Clinical Research Informer

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. All three medications […]

Clinical Trials

March 7, 2024: New Report Sets Out Posttrial Responsibilities in Pragmatic Clinical Trials

Rethinking Clinical Trials

MARCH 7, 2024

Stephanie Morain In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists and implementation scientists argue for a “presumptive default” that the results of pragmatic clinical trials should be incorporated into healthcare delivery processes. Read the full article.

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AAIC 2024: the evolution of Alzheimer’s clinical trials

Pharmaceutical Technology

JULY 29, 2024

Clinical trial trends point to studying combination therapies and lifestyle changes using alternate designs in Alzheimer’s research.

Clinical Trials

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.

September 11, 2024: HARMONIE and a New Approach to Commercial Clinical Trials, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

SEPTEMBER 11, 2024

Professor Saul Faust In this Friday’s PCT Grand Rounds, Saul Faust of the University of Southampton will present “The HARMONIE Trial: Reimagining How to Design and Deliver Contract Commercial Clinical Trials.” ” The Grand Rounds session will be held on Friday, September 13, 2024, at 1:00 pm eastern.

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Advent of decentralised clinical trials spurs need for robust rules like USFDA’s Cancer Clinical Trial Eligibility Criteria

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 19, 2024

As India sees the emergence of decentralised clinical trials driven by digital health technologies remote patient monitoring, Electronic Health Records andpatient data capture, it also sees robust rules like the US FDA’s Cancer Clinical Trial Eligibility Criteria as an advantage.

Clinical Trials

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Including Patients with Borderline Personality Disorder in Clinical Trials

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.

Clinical Trials

Optimizing Patient-Driven Site Engagement in Rare Disease Clinical Trials

Worldwide Clinical Trials

AUGUST 29, 2024

By: Nathan Chadwick, Therapeutic Strategy Lead, Rare Disease Over the last few years in clinical trials, particularly within the rare disease community, a notable shift is underway, where patients and caregivers are taking the lead in reaching out to clinical trial sites rather than the other way around.

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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.

ICMR and Panacea Biotec initiate phase 3 clinical trial for the first indigenous dengue vaccine, DengiAll

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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Women want to participate in clinical trials. Lack of flexibility is still a problem.

Bio Pharma Dive

APRIL 8, 2024

Underrepresentation of women in clinical trials affects the resulting drugs that become available later. Even small changes could boost participation.

Clinical Trials

How Pharmacogenomics Can Benefit Your Clinical Trial

Worldwide Clinical Trials

MARCH 20, 2024

One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials.

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Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports

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).

Clinical Trials

The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays.

Comprehensive clinical trial services

Pharmaceutical Technology

APRIL 18, 2024

Discover the key factors and latest advancements in clinical trial services to ensure the success of your clinical research. Find your comprehensive guide here.

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Move to relax clinical trial norms will cut Indian pharma’s human studies cost, lower drug prices for patients

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.

Clinical Trials

Understanding the Patient Journey: Overcoming Barriers to Enrolling Depression Clinical Trials

Worldwide Clinical Trials

JULY 8, 2024

By: Lisle Kingery, PhD, Therapeutic Strategy Lead, Neuroscience With depression rates at an all-time high and limited new treatments available, depression clinical trials are more important than ever. Treatment Treatment can take various forms, including therapy, medication, a combination of both, or a clinical trial.

Clinical Trials

Revolutionizing clinical trials: Unlocking peak efficiency with total laboratory automation in bioanalysis

Bio Pharma Dive

DECEMBER 4, 2023

With clinical trials becoming more complex, finding ways to streamline and automate laboratory processes is vital when analyzing bioanalytical samples.

Clinical Trials

Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies.

December 13, 2023: In This Week’s PCT Grand Rounds, a Path Forward for Diversifying Clinical Trials

Rethinking Clinical Trials

DECEMBER 13, 2023

In this Friday's PCT Grand Rounds, Roxana Mehran of the Icahn School of Medicine at Mount Sinai will present "Diversifying Clinical Trials: A Path Forward." Mehran is a professor of medicine and the director of interventional cardiovascular research and clinical trials at the Zena and Michael A. Join the online meeting.

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Growing number of lifesciences GCCs underscores India’s importance in R&D and clinical trials

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 6, 2024

This according to multinational majors like Amgen, GSK, Eli Lily, Bayer, Mylan, AstraZeneca among others indicated that it underscores India’s importance in R&D and clinical trials. These GCCs in the lifesciences and healthcare segment are driving digital tech assignments, key business and corporate […]

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Clinical trials and development services

Pharmaceutical Technology

APRIL 4, 2024

Download our comprehensive list of leading specialist companies offering clinical trials and development services for free today.

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Non-small cell lung cancer: the global clinical trials landscape 2024

Pharmaceutical Technology

JULY 16, 2024

Accounting for around 85% of lung cancer cases worldwide, non-small cell lung cancer is a key research area for clinical trials in 2024.

Clinical Trials

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

How SaaS platforms are breaking the mold for clinical trials

Pharmaceutical Technology

AUGUST 6, 2024

Clinical trials are increasingly relying on software-as-a-service (SaaS) providers to optimize efficiencies.

Clinical Trials

UK clinical trials industry tackles recent changes in the sector

Pharmaceutical Technology

MAY 20, 2024

The Annual Outsourcing in Clinical Trials conference will gather pharma experts to discuss the UK clinical trial landscape.

Clinical Trials

Four key trends in the clinical trial supply chain

Pharmaceutical Technology

JUNE 10, 2024

Clinical trial supply chains have experienced significant changes in recent years. We identify the four key trends.

Clinical Trials

Embracing diversity in psychiatry and neurology clinical trials

pharmaphorum

SEPTEMBER 6, 2024

Embracing diversity in psychiatry and neurology clinical trials is crucial for ensuring that treatments are effective for all populations. Learn about the importance of diversity in clinical trials and how to promote inclusivity in research.

Clinical Trials

Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials.

Clinical Supply

AI-driven insights: SOMS boosts clinical trial success

Outsourcing Pharma

SEPTEMBER 5, 2024

In an in-depth conversation, OSP senior editor, Liza Laws, interviews Adrian Kizewski, associate director at IQVIA, to uncover the transformative impact of the Sub-population Optimization & Modeling Solution (SOMS) on clinical trials.

Clinical Trials

Mastering Clinical Trial Timelines

Imperical Blog

AUGUST 20, 2024

Realistic, well-managed clinical trial timelines are essential to the success and timeliness of clinical studies. We often say every clinical trial is made up of a million moving parts. Read on for more information about keeping your projects on track.

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Bridging science and humanity: Systems thinking in clinical trial design

Bio Pharma Dive

JUNE 24, 2024

Benefits of adopting the systems thinking approach in clinical trial design.

Clinical Trials

Why informed patient consent is vital for successful clinical trials

pharmaphorum

JULY 1, 2024

Informed patient consent is crucial for the success of clinical trials. Learn about the importance of consent in clinical trials and how it impacts the outcomes.

Clinical Trials

Running Decentralized Trials at Scale: Planning for Success

There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient.

Trials

A Perspective on Possible Applications of Artificial Intelligence to the Clinical Trial Workforce

ACRP blog

SEPTEMBER 4, 2024

Clinical trials provide the scientific foundation for justifying the safety and efficacy of drugs, biologics, and devices—but are laborious, expensive, and risky. Only 10% of drugs entering clinical trials receive U.S. clinical trial workforce reported burnout since the 2020 COVID-19 pandemic.{4}

Clinical Trials

How long do clinical trials take?

Antidote

APRIL 4, 2024

Before it is released onto the market, the development of any new drug or medical device must undergo rigorous testing , part of which involves clinical trials. Clinical trials are integral to making sure that any new therapy is both safe and effective for individuals, and volunteers are a vital part of the process.

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5 cybersecurity guidelines for remote monitoring in clinical trials

pharmaphorum

JULY 30, 2024

Implementing strong cybersecurity guidelines for remote monitoring in clinical trials is crucial to protect sensitive data. Learn these top 5 guidelines to secure your remote monitoring plan effectively.

Clinical Trials

Harnessing Data to Build More Inclusive Clinical Trials

XTalks

SEPTEMBER 12, 2024

Ryan Brown Regional Vice President Sales-Trial Landscape H1 Diversity in clinical trials is not just a regulatory box to check — it’s an ethical imperative and a scientific necessity. For instance, one common barrier is language.

Clinical Trials

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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

Who decides whether you get into a clinical trial?

Antidote

MAY 30, 2024

One may choose to participate in a clinical trial for many reasons. However, deciding to enroll in a clinical trial is only one part of the process. Volunteering often has multiple benefits, from advancing medical research to gaining access to cutting-edge medical care.

Clinical Trials

The Challenges of Adopting Decentralized Clinical Trial Platforms

Cloudbyz

APRIL 17, 2024

Decentralized clinical trial (DCT) platforms represent a paradigm shift in the way clinical research is conducted. By leveraging technology, DCTs aim to make clinical trials more accessible and convenient for patients, reduce costs and increase efficiency.

Clinical Trials

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Navigating Deaths During Clinical Trials

BioSpace

JULY 28, 2024

Fatalities are an unfortunate reality of clinical trials. How can companies best protect themselves?

Clinical Trials

Clinical trial trends and the rise of site networks

pharmaphorum

JULY 11, 2024

Tune in to Caroline Redecker and Jason Casarella as they discuss clinical trial trends and the rise of site networks in this insightful podcast episode brought to you by Advanced Clinical.

Clinical Trials

Commercial Drug Sourcing for Clinical Trials

The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors successfully navigate these challenges.