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 171

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 Trials Clinical Trials Trials Genetics 130

Rethinking Clinical Trials

MAY 21, 2024

May 19, 2024: The NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop at the 2022 Health Care Systems Research Network (HCSRN) Annual Conference. Workshop Summary & Additional Resources Agenda and Slides Welcome and Introduction Emily O'Brien, PhD Session 1: What Are Embedded PCTs (ePCTs)?

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Clinical Trials Clinical Trials Trials Research 100

Pharmaceutical Technology

MAY 1, 2024

Two such tools – electronic patient-reported outcomes (ePRO) and electronic clinical outcomes assessments (eCOA) – are often mentioned together. However, they serve distinct purposes and come with different considerations for clinical trial sponsors and contract research organisations (CROs).

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Clinical Trials Clinical Trials Trials Research 130

Pharmaceutical Technology

MAY 1, 2024

Two such tools – electronic patient-reported outcomes (ePRO) and electronic clinical outcomes assessments (eCOA) – are often mentioned together. However, they serve distinct purposes and come with different considerations for clinical trial sponsors and contract research organisations (CROs).

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Clinical Trials Clinical Trials Trials Research 130

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.

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Clinical Trials Clinical Trials Trials Medicine 182

XTalks

MAY 30, 2024

At the forefront of transforming clinical studies is the Clinical Trials Transformation Initiative (CTTI) , which has been instrumental in shaping the future of clinical trials to be more efficient, inclusive and patient-centered.

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Clinical Trials Clinical Trials Trials Clinical Research 52

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2024

Oncologists during clinical trials of paediatric cancer cases are seen to encounter parent reluctance. Since the trials involve a lot of government permissions as well and many healthcare facilities, hospitals under NDA […]

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Clinical Trials Clinical Trials Trials Clinical Research 150

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.

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Clinical Trials Clinical Trials Trials Clinical Research 265

Worldwide Clinical Trials

FEBRUARY 26, 2024

With the necessary prioritization of various factors when designing your clinical trial, the patient experience can be overlooked or improperly addressed in study design. From a combined perspective, somewhere along the way, we tend to be able to land at what is the true design of clinical research,” says Perez.

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Clinical Trials Clinical Trials Trials Clinical Research 147

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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Clinical Trials Clinical Trials Trials Development 182

Bio Pharma Dive

AUGUST 7, 2023

The need for more research into rare diseases is clear, but researchers face significant challenges. Fortunately, technology has created opportunities to innovate in clinical trials for rare diseases.

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Clinical Trials Clinical Trials Trials Research 244

Bio Pharma Dive

NOVEMBER 13, 2023

Explore how decentralized clinical trials (DCTs) can enhance rare disease research in three key ways.

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Clinical Trials Clinical Trials Trials Research 148

Rethinking Clinical Trials

OCTOBER 22, 2023

What Are Pragmatic Clinical Trials? Description In this video, Dr. Lesley Curtis describes pragmatic clinical trials. The post What Are Pragmatic Clinical Trials? The post What Are Pragmatic Clinical Trials? appeared first on Rethinking Clinical Trials.

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Clinical Trials Clinical Trials Trials Clinical Research 130

Pharmaceutical Technology

FEBRUARY 13, 2024

Research indicates that designing clinical trials with the patient in mind reduces recruitment times and enhances trial performance.

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Clinical Trials Clinical Trials Trials Research 147

Pharmaceutical Technology

JANUARY 3, 2024

A new report from Novotech delves into the multifaceted landscape of HIV, focusing on its impact, treatment, and global initiatives.

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Clinical Trials Clinical Trials Trials Research 295

Rethinking Clinical Trials

JANUARY 8, 2024

In a new article from the NIH Pragmatic Trials Collaboratory, investigators from 6 of the program’s pragmatic clinical trials share case examples of the challenges they encountered in collecting patient-reported outcomes (PROs) in their trials and the strategies they used to address them.

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Trials Clinical Trials Clinical Trials Research 298

ProRelix Research

FEBRUARY 20, 2024

Crafting impactful oncology clinical trial protocols requires a strategic approach to ensure rigorous research, patient safety, and meaningful outcomes.

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Clinical Trials Clinical Trials Trials Research 97

Antidote

JANUARY 18, 2024

Antidote’s mission is to connect patients with medical research so medical breakthroughs can take place. We provide our clinical trial matching technology, Antidote Match, at no cost to these organizations, to help patients and caregivers discover new research opportunities and connect to clinical trials quickly and easily.

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Clinical Trials Clinical Trials Trials Research 105

Rethinking Clinical Trials

FEBRUARY 21, 2024

In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.” He also serves as co-principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center. Join the online meeting.

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Clinical Trials Clinical Trials Trials Bioinformatics 130

ProRelix Research

MAY 31, 2023

Introduction: Clinical trials are a crucial component of the pharmaceutical and medical research industry, aimed at evaluating the safety and effectiveness of new drugs, treatments, or medical devices before they […] The post Successful Clinical Trial With ProRelix Research: Phase 1, 2, 3 & 4 Clinical Trial Services at … appeared (..)

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Clinical Trials Clinical Trials Trials Research 98

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.

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Clinical Trials Clinical Trials Trials Compliance 93

Rethinking Clinical Trials

SEPTEMBER 5, 2023

The NIH Pragmatic Trials Collaboratory is launching a special Grand Rounds series to share advances in the design and analysis of pragmatic clinical trials. Recordings will be archived on the Rethinking Clinical Trials website. The series will include 3 additional moderated webinar discussions.

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Clinical Trials Clinical Trials Trials Research 200

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 3, 2023

Pharmaceutical giant Eli Lilly said Thursday it will seek approval to add its diabetes drug to the buzzy US weight loss market after achieving promising results in a new clinical trial. Tirzepatide, currently approved to treat type 2 diabetes under the name Mounjaro, is taken once a week as an injection. Eli Lilly said its […]

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Clinical Trials Clinical Trials Trials Drugs 186

Cloudbyz

APRIL 23, 2024

The landscape of clinical trial management is marked by complexity, with organizations facing numerous challenges in effectively managing trial budgets while ensuring adherence to regulatory requirements and maintaining high standards of quality.

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Clinical Trials Clinical Trials Trials Regulation 85

Pharma Mirror

JUNE 15, 2023

In recent years, the field of clinical trials has witnessed a significant transformation due to advancements in technology. The integration of technology into clinical trials has revolutionized the way researchers conduct studies, collect data, and analyze results.

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Clinical Trials Clinical Trials Trials Research 130

Antidote

MAY 30, 2024

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

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Clinical Trials Clinical Trials Trials Research 52

Antidote

SEPTEMBER 25, 2023

Clinical trials are how researchers advance their knowledge about potential new treatments, including medications, medical devices, and lifestyle interventions. Clinical trials are divided into phases , each with a distinct duration, purpose, and number of volunteers needed.

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Clinical Trials Clinical Trials Trials Marketing 128

Outsourcing Pharma

APRIL 29, 2024

OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.

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Clinical Trials Clinical Trials Regulation Trials 103

Antidote

JANUARY 5, 2024

Though clinical trial patient recruitment is an integral part of the medical research process, it is often one of the most difficult aspects of conducting a study.

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Clinical Trials Clinical Trials Trials Research 124

Cloudbyz

MAY 17, 2024

This Act is poised to significantly change the clinical trials landscape within the life sciences sector. As AI increasingly becomes a cornerstone in clinical research and drug development, it is crucial for industry stakeholders to grasp the extensive implications of this regulation.

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Life Science Clinical Trials Clinical Trials Trials 79

Antidote

SEPTEMBER 26, 2023

Recruiting patients for a clinical trial can be a challenging process. Studies show that many patients report having little or no knowledge of clinical trials , and sponsors and researchers often report having difficulties finding and enrolling patients in studies.

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Clinical Trials Clinical Trials Trials Research 98

Antidote

JANUARY 29, 2024

For individuals living with a condition like melanoma, volunteering to participate in a clinical trial can be a rewarding experience. Individuals with Jamie’s specific diagnosis are given a 14% 5-year survival rate — but through participating in an immunotherapy clinical trial, Jamie is living without evidence of the disease.

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Clinical Trials Clinical Trials Trials Doctors 122

pharmaphorum

JANUARY 23, 2024

Bringing clinical trials to patients has become easier with the advent of digital technologies and decentralised clinical trials (DCTs). Learn how the hybrid approach combining traditional and digital methods can benefit patients and advance medical research.

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Clinical Trials Clinical Trials Trials Research 109