Clinical Trials, Drugs and Nurses - Clinical Research Informer

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.

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

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. Participating in a clinical trial is a significant decision that can have profound benefits, not only for the individual participant but also for future patients and the broader medical community.

Clinical Trials

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Lilly's antibody drug prevents COVID-19 in study, but hurdles to use remain

Bio Pharma Dive

JANUARY 20, 2021

Results from a clinical trial in nursing home residents and staff offered the first evidence Lilly's bamlanivimab could protect against, as well as treat, COVID-19

Nurses

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Cancer Professional and Survivor: ‘Without Clinical Trials, People Like Me Would Have No Hope’

ACRP blog

FEBRUARY 26, 2024

The irony―I am a cancer nurse and have been all my career. …My My office manages all of the cancer clinical trials for all types of cancer. Every drug I have received so far is the result of men and women participating in clinical trials that have shown these drugs are safe and effective in the treatment of breast cancer.

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

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Equal Parts Caregiver and Advocate: Clinical Trials from the Caregiver’s Point of View

Camargo

NOVEMBER 22, 2021

In this Q&A, Andrea discusses their experience, especially as it relates to the two clinical trials Tom participated in. We wanted to participate in a clinical trial. But our original doctor doesn’t work with clinical trials—it’s just not his thing. And I started researching trials.

Clinical 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

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

Rethinking Clinical Trials

MARCH 28, 2024

This reference guide offers essential guidelines in instances where direct input is not an option,” said Rosa Gonzalez-Guarda, cochair of the Health Equity Core and an associate professor and assistant dean in the Duke University School of Nursing. “We View the Equitable Language Cheat Sheet.

Trials

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Improving clinical trials through patient experience

Drug Discovery World

FEBRUARY 9, 2023

Stitch Health is a London-based start-up, on a mission to improve clinical trials by measuring and surfacing each patient’s experience. million seed funding to create the definitive patient retention platform for clinical trials. MT: What other aspects of clinical trials do you feel could be improved upon?

Clinical Trials

Grand Rounds February 17, 2023: The Heartline Trial: A New Paradigm in Conducting Virtual Clinical Trials (C. Michael Gibson, MS, MD)

Rethinking Clinical Trials

FEBRUARY 22, 2023

It will demonstrate that we can do trials at less cost than a normal trial (about 1% of a normal study). The question is can we pivot from very expensive trials to test cardiovascular drugs to at least a hybrid model that takes the best of what we have learned so far from the Heartline Trial?

Clinical Trials

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

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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

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Report: huge inequalities in access to myeloma clinical trials in Europe

Drug Discovery World

DECEMBER 6, 2022

Myeloma Patients Europe (MPE) has launched an advocacy report on addressing access barriers to myeloma clinical trials in Central and Eastern Europe (CEE). . The MPE report presents clinical trial analytics, looking at the number of clinical trials held in CEE countries between 1 January 2001 and 28 September 2020.

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.

Cardiac Biomarkers in Cardiovascular Clinical Trials: Caveats and Considerations

XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

Clinical Trials

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The Year Ahead in Trends, Challenges, and Opportunities for Clinical Trial Sites

ACRP blog

JANUARY 10, 2024

Views from ACRP Members Topics highlighted include diversity and inclusion, decentralized clinical trial (DCT) elements, workforce challenges, and a possible role for sponsors and contract research organizations (CROs) in supporting outreach by sites based in diverse communities.

Clinical Trials

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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

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

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December 13, 2022: In Our Tenth Year, a Wealth of New Insights From the NIH Pragmatic Trials Collaboratory

Rethinking Clinical Trials

DECEMBER 13, 2022

Investigators from the NIH Pragmatic Trials Collaboratory in 2022 shared study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory.

Trials

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Here’s a new data point for cancer patients to consider: ‘time toxicity’

STAT News

APRIL 10, 2023

She added up the time involved: waiting for a nurse to arrive to draw her blood; waiting for a courier to pick up her blood; waiting for another courier to drop off the chemotherapy drugs; waiting for a nurse to arrive to connect her to the infusion pump and later for another nurse to return to disconnect her.

Nurses

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Your HCP marketing just became harder, a lot harder

World of DTC Marketing

JUNE 11, 2021

Health care professionals have been critical of these agencies’ decisions during the pandemic, with some concerned that their work has been politicized and now with advisory panel members resigning as a result of the terrible decision to approve Biogen’s drug you can bet that HCPs are going o want to see a lot more clinical data.

Marketing

Marketing Nurses Doctors Doctor

Avoiding Radiation Toxicity: Understanding Dosimetric Endpoints and Challenges in Radiopharmaceutical Clinical Trials

XTalks

FEBRUARY 13, 2023

While considered a relatively new class of cancer drugs, isotopes employed as radiation therapy is not a new concept. Guarnaschelli reviewed the medical considerations involved in radiopharmaceutical clinical trials. There are many radiopharmaceutical agents that are approved by the US Food and Drug Administration (FDA).

Clinical Trials

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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. The vaccine currently being tested stimulates the body’s immune system to produce antibodies to oxycodone.

Clinical 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

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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

Both drugs have a well-established safety profile and would be a good fit for a pragmatic design. The study started in June 2016 and ended in June 2022 and ultimately found no difference between the 2 drugs in preventing major CV outcomes and non-cancer death among hypertensive VA patients.

Clinical Trials

Clinical Trials Clinical Trials Cardiology Trials

Unlocking the potential of direct-to-patient as decentralised trials continue to grow

Pharmaceutical Technology

JUNE 23, 2022

This challenging environment, in addition to the measures taken to restrict people’s movement in order to reduce the viruses spread, led to many of the vital clinical trials being carried out to shift towards decentralised trial procedures that utilised virtual medicine and direct-to-patient (DtP) drug delivery.

Trials

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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].

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Doctors don’t have time for digital

World of DTC Marketing

APRIL 27, 2021

When I asked why the nurse at the front desk said that they are overwhelmed with patients who are finally coming out of Covid hibernation. With the CDC relaxing COVID guidelines, one has to wonder when drug reps will start using their company cars that have been idle for over a year. Of course, it really depends on specialty.

Doctors

Doctors Doctor Nurses Clinical Trials

Why I Fight | A message from Gary Fishbein, MD, MPH

Worldwide Clinical Trials

MAY 24, 2022

Join us as we celebrate cancer research awareness month and clinical trials awareness month. Where I trained at the University of Maryland, there was literally a bridge that connected the research labs to the clinic. Life after cancer is about more than just survival. Building Bridges. Every Patient Is Precious.

Clinical Trials