Clinical Trials, Development and Nurses - Clinical Research Informer

The next phase of decentralisation in clinical trials

Pharmaceutical Technology

APRIL 20, 2023

Rather than bringing patients to sites, study teams are now exploring ways they can bring the trial to patients using a varying combination of direct-to-patient drug shipments, home nursing, video conferencing, and electronic data collection. Drug development had to change. There is data to support this possibility.

Clinical Trials

Traditional vs patient-centric clinical trial design

Deltaclinical

NOVEMBER 2, 2021

Along with a team of nurses and other stakeholders, the PI will conduct the trial at his/her study site. However, the sponsor will remain the monitor of the trial. The next figure shows the important stakeholders in a clinical trial. Patient-centric clinical trial design.

Clinical Trials

Benefits of Participating in Clinical Trials

Olympian Clinical Research

MARCH 19, 2024

Clinical trials are essential for advancing medical knowledge and developing new treatments that can improve patient care and outcomes. In Tampa Bay, Olympian Clinical Research is at the forefront of this vital work, offering local residents the opportunity to contribute to medical advancements.

Clinical Trials

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Traditional vs patient-centric clinical trial design

Deltaclinical

NOVEMBER 2, 2021

Along with a team of nurses and other stakeholders, the PI will conduct the trial at his/her study site. However, the sponsor will remain the monitor of the trial. The next figure shows the important stakeholders in a clinical trial.

Clinical Trials

Traditional vs patient-centric clinical trial design

Deltaclinical

NOVEMBER 2, 2021

Along with a team of nurses and other stakeholders, the PI will conduct the trial at his/her study site. However, the sponsor will remain the monitor of the trial. The next figure shows the important stakeholders in a clinical trial. Patient-centric clinical trial design.

Clinical Trials

Traditional vs patient-centric clinical trial design

Deltaclinical

NOVEMBER 2, 2021

Along with a team of nurses and other stakeholders, the PI will conduct the trial at his/her study site. However, the sponsor will remain the monitor of the trial. The next figure shows the important stakeholders in a clinical trial. Patient-centric clinical trial design.

Clinical Trials

NORD’s Dr. Neilan Discusses Next Steps for Rare Disease Clinical Trials

XTalks

DECEMBER 22, 2022

Neilan has contributed to the rare disease community through his comprehensive work in the rare disease space that has included research, academia, medical practice and clinical trial design and execution. Can you tell us a bit about the work you are doing at NORD and how it impacts clinical trials for rare diseases?

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

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

Rethinking Clinical Trials

MARCH 28, 2024

Rosa Gonzalez-Guarda The NIH Pragmatic Trials Collaboratory’s Health Equity Core developed a written aid to offer guidance on inclusive language and terms to use when referring to specific people, groups, and communities. View the Equitable Language Cheat Sheet.

Trials

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October 31, 2023: NIH Pragmatic Trials Collaboratory Welcomes 5 New Demonstration Projects

Rethinking Clinical Trials

OCTOBER 31, 2023

The study is administered by the National Institute of Nursing Research and will be conducted by Diana Burgess of the Minneapolis Veterans Affairs Healthcare System, Roni Evans of the University of Minnesota, and Katherine Hadlandsmyth of the University of Iowa.

Trials

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December 12, 2023: A Year of New Insights From the NIH Pragmatic Trials Collaboratory

Rethinking Clinical Trials

DECEMBER 12, 2023

Investigators from the NIH Pragmatic Trials Collaboratory in 2023 shared study results, generated new knowledge, and developed innovative methods in the design, conduct, and analysis of pragmatic clinical trials.

Trials

Trials Clinical Trials Clinical Trials Nurses

January 11, 2024: BeatPain Utah Study Team Uses Implementation Mapping Approach to Plan Hybrid Trial

Rethinking Clinical Trials

JANUARY 11, 2024

During the 1-year planning phase described in the article, the study team developed a logic model, based in part on the Consolidated Framework for Implementation Research (CFIR), to identify contextual factors across several domains that could influence e-referral and telehealth implementation in the trial.

Trials

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Abbott Builds Upon Diversity in Clinical Trials Initiative by Partnering with Women as One

XTalks

MAY 16, 2022

The partnership between Abbott and non-profit Women as One will train female and underrepresented physicians to help improve diversity in clinical trials. In a study that analyzed the demographics of clinical trial participants of the 102 new drugs approved between 2013 to 2015 by the FDA’s CDER, only 40.4

Clinical Trials

Bias in Electronic Health Records May Affect Clinical Trials

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.

Clinical Trials

January 2, 2023: NINR Announces Funding Opportunity to Address Social Needs Through Healthcare-Community Partnerships

Rethinking Clinical Trials

JANUARY 2, 2024

The post January 2, 2023: NINR Announces Funding Opportunity to Address Social Needs Through Healthcare-Community Partnerships appeared first on Rethinking Clinical Trials. Registration is required.

Nurses

Nurses Clinical Trials Clinical Trials Research

Wearable Biosensors for Decentralized and Hybrid Clinical Trials

XTalks

JANUARY 19, 2022

The way in which clinical trials are conducted is entering a new dimension as clinical trial operations are becoming more adaptable. The COVID-19 pandemic certainly has pushed to the forefront of clinical trials, the digital evolution in clinical research. MRI scan, endoscopy, etc.)

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Bias in Electronic Health Records May Affect Clinical Trials

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.

Clinical Trials

ACRP 2023 Speakers Emphasize Impacts of Quality and Diversity on Clinical Trial Sites

ACRP blog

APRIL 29, 2023

Among many other topics, speakers at this weekend’s ACRP 2023 gathering in Dallas, Texas, are sharing insights on the importance of building quality into clinical trials and increasing diversity among the staff and patients at the study site level. At the trial level, the protocol is the blueprint for quality.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research Coordinator

Decentralized Clinical Trials Enable Participation for Immobile Patients

VirTrial

DECEMBER 17, 2019

Clinical trials require a significant commitment from patients, particularly in regard to travel time to research sites for regular visits. Consider the additional patient burden involved in clinical trials for patients with paralysis, dementia, or other conditions that make travel difficult or impossible.

Clinical Trials

We make clinical research easy.

Deltaclinical

DECEMBER 9, 2022

Clinical trials in drug development are a vital part of the process to bring new medicines to patients. Our clinical site support services help to stay cost effective while meeting your study objectives in a swift manner.

We make clinical research easy.

Deltaclinical

DECEMBER 9, 2022

Clinical trials in drug development are a vital part of the process to bring new medicines to patients. Training study nurse. Our clinical site support services help to stay cost effective while meeting your study objectives in a swift manner. Data processing (eCRF). Quality control. Pre-)screening calls.

We make clinical research easy.

Deltaclinical

DECEMBER 9, 2022

Clinical trials in drug development are a vital part of the process to bring new medicines to patients. Training study nurse. Our clinical site support services help to stay cost effective while meeting your study objectives in a swift manner. Data processing (eCRF). Quality control. Pre-)screening calls.

We make clinical research easy.

Deltaclinical

DECEMBER 9, 2022

Clinical trials in drug development are a vital part of the process to bring new medicines to patients. Training study nurse. Our clinical site support services help to stay cost effective while meeting your study objectives in a swift manner. Data processing (eCRF). Quality control. Pre-)screening calls.

July 17, 2023: NIH Pragmatic Trials Collaboratory Welcomes First Class of Fellows

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.

Trials

Trials Clinical Trials Clinical Trials Nurses

On the front lines: Correctional nurses and the COVID-19 pandemic

Bioengineer

JULY 15, 2021

New Rochelle, NY, July 14, 2021-Firsthand reports from nurses in correctional facilities detail the challenges they faced during the COVID-19 pandemic. These firsthand accounts are reported in a special issue on correctional nursing in the Journal of Correctional Health Care. Credit: Mary Ann Liebert, Inc., publishers. liebertpub.

Nurses

Nurses Genetic Engineering Engineer Genetics

Patient-Centricity and Decentralized Clinical Trials

Crucial Data Soutions

NOVEMBER 16, 2022

Despite the rise in utilization of decentralized clinical trial (DCT) elements, there are still many misconceptions. While the last few years have allowed many research stakeholders to see firsthand the ability of DCT elements to help reach patients outside the clinic setting, there remain concerns and questions.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

What Does Covid-19 Mean for Patients in Clinical trials?

Find Me Cure

APRIL 2, 2020

The last couple of weeks had us write many emails to patients applying for clinical trials informing them that the trial they are interested in has been suspended. However, right now researchers are still trying to make sense of the way social distancing is going to impact clinical trials in order to plan for the future.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Integrate RBQM Into Each Phase of the Clinical Trial “House”

WCG Clinical

JULY 11, 2023

Risk-based quality management (RBQM) isn’t something you merely add to an existing clinical trial. The basement is risk assessment, the ground floor is protocol development, and the top floor is the monitoring and quality assurance (QA) plan. That is what we really should be basing the foundation of all our clinical trials on.”

Clinical Trials

ACRP Views on FDA Draft Guidance on Decentralized Clinical Trials

ACRP blog

MAY 17, 2023

Clinical research professionals are on the front lines of decentralized clinical trial (DCT) implementation – an evolution that is transforming clinical research. Food and Drug Administration (FDA) draft guidance on decentralized clinical trials. ACRP welcomes newly published U.S.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

January 30, 2023: NIH Pragmatic Trials Collaboratory Begins 2023 With New Cores in Health Equity and Implementation Science

Rethinking Clinical Trials

JANUARY 30, 2023

Gonzalez-Guarda is an associate professor of nursing at Duke University, faculty lead for the Population Health Research Area of Excellence at Duke’s Center for Nursing Research, and codirector of the Community Engagement Core for Duke Clinical Translational Science Institute. Devon Check and Dr. Hayden Bosworth.

Trials

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Today’s Forecast: 5 Predictions About the Future of Clinical Trials

Imperical Blog

MAY 20, 2020

If the patient can’t come to the trial, we have to bring the trial to the patient, and that is what is happening in record time. Protocol rewrites and approvals are taking place, with visits to the study site replaced by telemedicine, visiting study nurses, video conferences, remote diagnostics, supply chain workarounds, and much more.

Clinical Trials

Clinical Trials Clinical Trials Trials Genetics

First-in-human clinical trial for a vaccine to treat opioid use.

The Pharma Data

SEPTEMBER 7, 2021

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

Lessons Learned from Implementing Competency-Based Job Classifications at Two AMCs

ACRP blog

FEBRUARY 29, 2024

Education and training remain key elements in the development and professionalization of the clinical research workforce. Duke University’s Schools of Medicine and Nursing currently employ more than 900 clinical research professionals, with around 200 new hires per year. public school system.

Clinical Research Clinical Trials Clinical Trials Nurses

Grand Rounds February 9, 2024: Pragmatic Recruitment of Underrepresented Groups – Experience From the Diuretic Comparison Project (Cynthia Hau, MPH)

Rethinking Clinical Trials

FEBRUARY 14, 2024

DCP developed an EHR-based workflows and integrated workflows within the local VA primary care setting. DCP developed 3 electronic workflows with 6 major configurations including applications needed outside of the EHR system. DCP developed a patient tracking tool that nurses could use to make sure patients got through each step.

Clinical Trials

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?5 Things You Need to Know from Our Recent Gene Therapy Webinar

Worldwide Clinical Trials

JUNE 15, 2022

At the end of May, we hosted a webinar titled “ Changing Times, Changing Therapies: Keeping Up with Advancements in Cell and Gene Therapies ” to provide a quick update on the latest advancements and ongoing in development of these advanced therapeutics. Clinical holds are becoming more common, especially in gene therapy programs.

Gene Therapy

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October 24, 2022: NIH Pragmatic Trials Collaboratory Announces 2 New Core Working Groups

Rethinking Clinical Trials

OCTOBER 24, 2022

Hayden Bosworth, PhD, is a health services and implementation researcher and Deputy Director for the Center for Health Services Research in Primary Care at the Durham VA Medical Center as well as Professor in the Department of Population Health Sciences and Professor of Medicine, Psychiatry, and Nursing at Duke University Medical Center.

Trials

Trials Nurses Clinical Research Research

The Benefits of Working for a Rapidly Growing Global Clinical Research Organization (CRO) like Medpace

XTalks

OCTOBER 18, 2022

A clinical research organization (CRO) is a company that delivers outsourced services to plan, manage and execute clinical trials for biotechnology, pharmaceutical, and medical device companies. This has led to a sharp increase in the number of clinical trials ( Figure 1 ). Source: [link]. Why Work for Medpace?