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

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. However, incorporating the patient experience into your design is one of the best ways to ensure your drug development program is a commercial success.

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XTalks

JULY 29, 2024

Orphan drug development poses many challenges that are unique to rare diseases, including recruitment in small patient populations, variable progression with heterogenous clinical manifestations and limited understanding of disease progression and natural history. Read on to learn key lessons in rare disease drug development.

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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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Worldwide Clinical Trials

FEBRUARY 28, 2023

Rob found out that in 1980, a researcher in Birmingham, England first synthesized a very niche cancer drug in a small lab. Over the next few decades, that drug made its way through clinical trials, securing approval in 2007—just 36 months before Rob was diagnosed in 2010. But what was truly remarkable?

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ProRelix Research

SEPTEMBER 7, 2023

Autoimmune disorders comprise several diseases in which the immune system mistakenly attacks and destroys the body’s own healthy cells instead of destroying bacteria and viruses to keep the body healthy. […] The post Autoimmune disorders and current developments of novel treatments under clinical trials appeared first on ProRelix Research.

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Clinical Trials Clinical Trials Trials Development 105

ACRP blog

AUGUST 14, 2024

Diversity in clinical research has become a hot topic in recent years, with heightened attention leading to dramatic changes in the regulatory framework, including U.S. legislation broadening the scope of diversity consideration in clinical trials. Hispanic/Latino representation in clinical trials is approximately 11.6%

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Clinical Trials Clinical Trials Trials Clinical Research 59

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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Rethinking Clinical Trials

AUGUST 20, 2024

The NIH Pragmatic Trials Collaboratory has launched a new interactive learning path that provides essential knowledge to research teams on how to choose the most appropriate study design for a pragmatic clinical trial. To access the learning path, visit the learning module page to sign up.

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Rethinking Clinical Trials

DECEMBER 5, 2023

Health Data Research Network (HDRN) Canada is now accepting applications for its Pragmatic Trials Training Program. There will be an emphasis on experiential learning for future trial leaders and postdoctoral fellows in the program through the development of a pragmatic trial protocol.

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ProRelix Research

SEPTEMBER 17, 2023

Since […] The post Ophthalmology disorders and current developments of novel treatments under clinical trials appeared first on ProRelix Research.

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Rethinking Clinical Trials

JUNE 27, 2022

A special series of articles addressing pragmatic and virtual trials appears this week in the journal Contemporary Clinical Trials and offers practical approaches to the many challenges clinical trials face. The special issue can be found on the Contemporary Clinical Trials website.

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Clinical Trials Clinical Trials Trials Clinical Research 147

XTalks

JANUARY 15, 2024

The field of clinical research will witness significant advancements in 2024. Read on to learn about the top 10 clinical trial trends for 2024, and be sure to explore and join upcoming webinars about clinical trials at Xtalks. percent from 2023 to 2033.

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Clinical Trials Clinical Trials Trials Clinical Research 105

Worldwide Clinical Trials

JANUARY 24, 2024

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.

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World of DTC Marketing

AUGUST 27, 2021

SUMMARY: Over half of all clinical trial sites are outside the U.S. 87 % of all subjects in recent biologics trials were enrolled outside the U.S. DTC may or may not work for clinical trial enrollment it really depends on the condition and risk as judged by the patient. According to antidote.com.

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World of DTC Marketing

OCTOBER 6, 2020

WHAT’S THIS ABOUT THEN : Researchers are rushing to launch clinical trials of experimental vaccines against the coronavirus, and treatments for COVID-19. Eli Lilly recently announced that it would halt enrolment in ongoing studies and delay the launch of new trials.

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Clinical Trials Clinical Trials Trials Drugs 180

Pharmaceutical Technology

APRIL 20, 2023

Medidata, part of Dassault Systèmes, has partnered with Lambda Therapeutics to automate and consolidate data management processes for improved clinical trial efficiency. Rave RTSM, which has been developed on Rave EDC, eliminates double data entry and requires reduced reconciliation that speeds up study start-up and close-out.

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Clinical Trials Clinical Trials Trials Clinical Research 130

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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Pharmaceutical Technology

MARCH 23, 2023

This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinical trial regulation in the UK with expedited timelines at several stages. The MHRA hopes this new framework “will remove obstacles to innovation” and “streamline the regulation of clinical trials” amongst other things.

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XTalks

JANUARY 17, 2024

Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense.

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XTalks

AUGUST 16, 2024

The effectiveness of clinical trials often depends on the quality and depth of the data utilized. This rich data resource has significant potential to innovate clinical trials, providing real-world, timely insights that can enhance success and streamline trial processes.

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Clinical Trials Clinical Trials Trials Clinical Research 59

XTalks

MAY 21, 2024

Yesterday, on International Clinical Trials Day 2024, the global healthcare community came together to commemorate the significant advancements in clinical research and the vital role clinical trials play in improving patient care and outcomes.

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Clinical Trials Clinical Trials Trials Clinical Research 64

ProRelix Research

JUNE 27, 2024

In the United States, The Food and Drug Administration (FDA) regulates and oversees clinical trials of food and dietary supplements and develops various regulations and guidelines for their use. The […] The post Food and Dietary Supplements Clinical Trials Regulations in USA appeared first on ProRelix Research.

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Clinical Trials Clinical Trials Regulation Trials 52

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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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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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

Outsourcing Pharma

JULY 24, 2024

As clinical trials continue to evolve, next-generation mobile technologies and applications are at the forefront of transforming the research landscape.

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Clinical Trials Clinical Trials Trials Research 61

Cloudbyz

JULY 30, 2024

Clinical trials are the cornerstone of medical research, driving innovation and advancements in healthcare. Effective management of clinical trials involves rigorous oversight of operations and careful tracking of key metrics to ensure trials are conducted efficiently, ethically, and in compliance with regulatory standards.

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XTalks

AUGUST 19, 2024

The synergy between clinical trial quality and operations teams is vital for delivering value to sponsors. Clinical trial sponsors often face the challenge of managing complex projects with multiple stakeholders, each with their own priorities and workflows.

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Clinical Trials Clinical Trials Trials Life Science 59

XTalks

AUGUST 22, 2023

Recruiting participants is perhaps the most challenging aspect of any clinical trial, regardless of the therapeutic area. Yet this one piece is also the most vital, with a trial’s ability to enroll and retain participants being a key predictor of a study’s future success. What is Clinical Trials For All?

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Clinical Trials Clinical Trials Trials Clinical Research 97

XTalks

MAY 9, 2023

Clinical trial manager jobs are vital for the development and execution of clinical trials, which are essential for developing new treatments for diseases. In this article, we discuss the job duties, education and experience requirements, outlook and salary expectations for clinical trial managers.

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Clinical Trials Clinical Trials Trials Clinical Research 98

pharmaphorum

FEBRUARY 8, 2024

Stay up to date with the latest updates in the world of clinical trials. This week's highlights include Bayer's new study on aflibercept, BioNTech's groundbreaking research, and the exciting developments from Duality Bio. Get all the important information here.

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Clinical Trials Clinical Trials Trials Development 108

Cloudbyz

AUGUST 5, 2024

Clinical trials, as a major portion of drug development, do tend to hold a huge environmental footprint, taking into consideration the quantity of resources used, travel needs, and waste generation. Environmental Impact of Traditional Clinical Trials Traditional clinical trials are resource-intensive and costly.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 16, 2024

Under […]

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XTalks

MAY 19, 2023

Clinical trials play a vital role in advancing patient treatment and medical care. This article delves into ten trends and statistics in the world of clinical trials for 2023. Increasing Number of Registered Clinical Trials As of May 17, 2023, there are 452,604 registered clinical trials globally on ClinicalTrials.gov.

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Clinical Trials Clinical Trials Trials Clinical Research 97

Cloudbyz

AUGUST 15, 2024

Randomization and Trial Supply Management (RTSM) play a pivotal role in the successful execution of clinical trials. As the complexity of clinical trials continues to increase, especially with the rise of multi-center, adaptive, and decentralized trials, the need for robust RTSM systems has become more critical than ever.

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ACRP blog

JANUARY 3, 2024

Historically, patient recruitment and retention have been pressing issues within the clinical trial space. Eighty-five percent of trials fail to recruit enough patients, while 80% are delayed due to other factors like participant dropouts.

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