Rethinking Clinical Trials

AUGUST 28, 2023

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. Time, cost and failure to recruit trial participants are significant barriers that must be addressed. – What are the next steps?

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XTalks

JANUARY 17, 2024

To gain insights into how clinical trials for lupus can be enhanced with RWD sources, we spoke with Frederico Calado, VP of Global Real-World Solutions at Alira Health , and Dr. Kaleb Michaud, Professor, Division of Rheumatology, University of Nebraska Medical Center. What kind of sources can provide RWD for Lupus solutions?

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Rethinking Clinical Trials

JULY 17, 2023

Kaitlyn McLeod The NIH Pragmatic Trials Collaboratory is welcoming its first class of fellows in a new program for early-career investigators from underrepresented or minoritized groups with a scholarly interest in pragmatic clinical trials.

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Rethinking Clinical Trials

DECEMBER 20, 2022

This training workshop introduces concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs), and provides firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory Demonstration Projects. Participant Guide. Speaker Biographies. Program Overview.

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ACRP blog

JUNE 15, 2023

Results of clinical trials are only as good as the data upon which they rest. This is especially true in terms of diversity—if most people in a trial are from a certain race or socioeconomic group, then the results may not be broadly applicable.

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Cloudbyz

MARCH 17, 2021

Monitoring patient safety during a clinical trial is one of the founding principles to be followed throughout the drug development life cycle. It can be defined as a collaborative relationship between sponsors, sites, researchers, and everyone involved in the clinical trial phases.

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ACRP blog

JUNE 15, 2023

Results of clinical trials are only as good as the data upon which they rest. This is especially true in terms of diversity—if most people in a trial are from a certain race or socioeconomic group, then the results may not be broadly applicable.

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Rethinking Clinical Trials

DECEMBER 18, 2023

December 10, 2023 : The NIH Pragmatic Trials Collaboratory hosted a Workshop at the 2023 AcademyHealth 16th Annual Conference on the Science of Dissemination and Implementation in Health.

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Pharmaceutical Technology

MAY 10, 2023

Gilead Sciences has acquired biotech company XinThera in an effort to bolster its oncology and inflammation pipeline. The acquisition will give Gilead Sciences access to XinThera’s portfolio of two small molecule inhibitor programmes, one of which targets PARP1 to treat cancer and the other of which targets MK2 for inflammatory diseases.

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XTalks

NOVEMBER 7, 2022

“Liquid biopsies have demonstrated promising activity in multiple clinical settings, but the great enthusiasm and expectations around them can be harmful if not adequately managed,” said Dr. El Mustapha Bahassi, PhD, Director, Clinical Laboratory Sciences, at the global clinical research organization (CRO) Medpace.

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Pharmaceutical Technology

JANUARY 29, 2023

The anti-SARS-CoV-2 drug candidate Xiannuoxin has been co-developed by Simcere Group, along with Shanghai Institute of Materia Medica (SIMM) and Wuhan Institute of Virology (WIV), Chinese Academy of Sciences (CAS). It showed broad spectrum antiviral activity and highly potent in pre-clinical trials.

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Cloudbyz

MAY 13, 2023

Overview: Clinical site monitoring metrics and Key Performance Indicators (KPIs) are fundamental tools in the realm of clinical trial management. They provide a way to quantify and evaluate critical aspects of a clinical trial’s performance at individual investigative sites.

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Advarra

MARCH 21, 2023

While drugs require Phase I-III clinical trials—and are also subject to post-approval tracking—digital therapeutics, devices, and IVDs may be able to leverage bench testing, animal studies, pilot studies, and training sets.

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Pharmaceutical Technology

DECEMBER 21, 2022

Under the collaboration, the company will also back the mRNA health and science ecosystem of the country. Optimise your cell therapy process: a guide to cell thawing. Planned to be operational by 2025, the construction of the facility is anticipated to begin early next year. Free Whitepaper.

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Pharmaceutical Technology

MAY 19, 2023

The financing will help to fast-track the development of other in vivo programming candidates into clinical trials. We are pioneering the convergence of immunology and RNA science to build a clinical-stage portfolio of products, starting with the significant unmet needs of cancer patients.

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Pharmaceutical Technology

MARCH 10, 2023

In an email to Pharmaceutical Technology , an NHSBT spokesperson said the centre will “support early phase clinical trials and preclinical work, providing a route to eventual commercial scale production”. In the past, researchers have often had to seek help from outside the UK, thus delaying clinical trials and patient access.

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Rethinking Clinical Trials

JULY 14, 2023

Tyson School of Medicine Slides Keywords Pragmatic Clinical Trial, GGC4H, Prevention Key Points Guiding Good Choices for Health Study (GGC4H) is about the Guiding Good Choices (GGC) intervention, a group-based program for parents and caregivers of younger adolescents (ages 9-14).

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Pharmaceutical Technology

JUNE 13, 2023

The funding, with participation from Oxford Science Enterprises (OSE), includes AGTC’s acquisition and capital to help accelerate Beacon Therapeutics’ candidate development. Amongst it was AGTC’s lead clinical candidate, AFTC-501, an adeno-associated virus (AAV) gene therapy for XLRP. The total financing was £96m ($120m).

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Pharmaceutical Technology

APRIL 3, 2023

The deal will see Polyplus join the German life science group’s portfolio allowing the latter to leverage expertise in transfection reagents and plasmid DNA for gene therapy. GlobalData, the parent company of Pharmaceutical Technology, outlines a rise in gene therapy trials in 2023, in line with the growing market Fáber describes.

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Pharmaceutical Technology

JUNE 12, 2023

AstraZeneca will take up the further development and commercialisation activities of the clinical candidates. Quell will handle their process development and manufacturing until the programme reaches the end of the first-in-human clinical trial. AstraZeneca will make an upfront payment to Quell of $85m, mostly in cash.

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Clinical Trial Podcast

JULY 31, 2022

Who owns the clinical trial data generated in industry sponsored or investigator initiated clinical trials? What responsibilities do Sponsors, CROs, or Sites have when it comes to sharing clinical trial results with patients? To answer these questions and more, I invited Darshan Kulkarni to the show.

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Rethinking Clinical Trials

APRIL 27, 2023

MyTEMP worked with patients and caregivers to develop the trial, and Kidney Patient and Family Advisory Councils guided the choice of additional outcomes. Participants were debriefed on the trial results. Learn more Read about the MyTEMP trial in The Lancet. Dixon, PhD MSc) appeared first on Rethinking Clinical Trials.

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Pharmaceutical Technology

JUNE 8, 2023

The Mendus team has correctly focused on the science and good clinical trial design, and we are now happy to join very competent investors Van Herk and AP4 to help Mendus scale manufacturing together with NorthX and translate their cutting-edge oncology, vaccine and cell therapy competence into products available to patients worldwide.”

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Pharmaceutical Technology

MAY 18, 2023

Other investors include Investissement Québec, Omega Funds, Cowen Healthcare Investments, CTI Life Sciences Fund III, Northleaf Capital Partners, BVF Partners and Vivo Capital. The proposed transaction will conclude in the second half of 2023.

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Rethinking Clinical Trials

JUNE 27, 2023

Anne Trontell and Ana Quiñones A focus of the 2023 NIH Pragmatic Trials Collaboratory Annual Steering Committee Meeting was health equity in embedded pragmatic clinical trials (ePCTs). The achievement of health equity is one of PCORI’s 5 guiding National Priorities for Health,” said Trontell.

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Drug Discovery World

DECEMBER 7, 2023

New guidance for the motor neuron disease (MND) drug discovery community has been published to ensure that future drug discovery and development efforts have the best chance of successfully translating from the lab to the clinic. The Guiding Principles underpin a new £5 ($6.2)

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Pharmaceutical Technology

DECEMBER 14, 2022

GSK has entered a strategic partnership with Wave Life Sciences to progress the discovery and development of oligonucleotide therapies for new genetic targets. On completion of the first-in-patient clinical trial by Wave, GSK will be in charge of the development and marketing works. Free Whitepaper.

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XTalks

JUNE 3, 2022

. “We have been using the inHEART solution in clinical research for several years. The company also states that early clinical evaluations show promise for image-guided ablations to increase the success rates of the procedure from 60 percent using the standard approach to 75 percent with the 3D heart modeling solution.

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CTTI (Clinical Trials Transformation Initiative)

OCTOBER 17, 2023

Previously, she served as vice president of the online patient research network PatientsLikeMe (PLM), where she led programs utilizing patient-generated health data in life sciences and regulatory settings. I am excited and honored to lead CTTI at such an exciting moment in its trajectory,” Hanger said. “We

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Drug Discovery World

JANUARY 24, 2023

Virtual clinical trials ‘Virtual’ and ‘technology’ are concepts which are readily exchanged in this industry, but these are more than just buzzwords. The overall virtual clinical trials market is currently valued at $7.8 However, it also made great strides in proving the success of these sorts of trials.

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pharmaphorum

AUGUST 19, 2021

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. Many guidelines focus narrowly on clinical trials that are intended to generate data for regulatory submission to support a new drug license.

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Rethinking Clinical Trials

JULY 13, 2023

There is renewed interest in implementation science in cardiometabolic care to better understand optimal pathways for delivering these therapies in patients with HFrEF. Bhatt, MD, MBA, ScM) appeared first on Rethinking Clinical Trials.

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Rethinking Clinical Trials

SEPTEMBER 22, 2022

Head of Center for Translational Cardiology and Pragmatic Randomized Trials. Department of Biomedical Sciences. Faculty of Health and Medical Sciences. DANFLU-1, Pragmatic Clinical Trials. You can always use the system to identify potential candidates and then guide them to the local cardiology, kidney department.

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pharmaphorum

NOVEMBER 2, 2022

Citeline provides intelligence, data and software for clinical trials, development and regulatory compliance and was formerly part of Informa was called Pharma Intelligence ahead of a rebranding earlier this year.

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Clinical Trial Podcast

MARCH 31, 2022

Did you know you can leverage your clinical data for clinical operational excellence across your organization? Mariam has several decades of leading and managing clinical data management projects and teams for medical devices and oncology drugs.

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Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

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Cloudbyz

APRIL 17, 2024

Cloudbyz, a pioneering start-up specializing in Unified eClinical solutions for the healthcare and life sciences industry, stands out as a beacon of environmental responsibility through its innovative sustainability program. Together, we can cultivate a greener, more resilient planet—one tree at a time.

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