pharmaphorum

AUGUST 6, 2021

Patient enrollment is a common issue across many therapeutic areas in clinical research. Psychiatric disorders in particular represent a trial area with significantly high drop-out rates and poor patient recruitment. The reasons behind this problem, however, are rarely studied or understood.

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Cloudbyz

MAY 24, 2023

In the complex and fast-paced pharmaceutical industry, the importance of clinical trials in drug development cannot be overstated. Managing a clinical trials portfolio is a crucial aspect of this process, requiring rigorous tracking and analysis. It provides insights into the financial efficiency of a clinical trial.

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Clinical Trials Clinical Trials Trials Drugs 52

Rethinking Clinical Trials

AUGUST 22, 2022

The COVID-OUT Trial is a remotely delivered, Phase 3, de-centralized clinical trial at 6 participating institutions to see if Ivermectin, Metformin or Fluvoxamine would prevent severe COVID-19. Initially, the randomization of the trial was 1:1 Metformin or Placebo. The primary outcome of the trial was negative.

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pharmaphorum

OCTOBER 18, 2022

Now that the COVID-19 pandemic has provided the industry with a solid foundation of experience with decentralised trials, it is appropriate to reflect and ask whether DCT studies are truly helping to address long-standing issues in research and development for sponsors, study teams and, most importantly, patients.

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Clinical Trials Clinical Trials Trials Development 93

Roots Analysis

OCTOBER 29, 2023

One particular area that has seen significant innovation is the realm of clinical trials. Traditionally conducted at centralized sites like hospitals or clinics, the latest trend is moving towards decentralized clinical trials (DCTs). What are Decentralized Clinical Trials (DCTs)?

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XTalks

FEBRUARY 6, 2024

Alarmingly, the cardiac ramifications of CKD are deep and manifold, and with cardiovascular disease (CVD) standing as the leading cause of death worldwide, it has especially important implications among CKD patients. Director of Clinical Trial Management. Watch the free webinar to hear their expert insights.

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Clinical Trials Clinical Trials Trials Clinical Research 96

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. Of the total registered studies, 64,838 are actively recruiting participants.

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Clinical Trials Clinical Trials Trials Clinical Research 97

pharmaphorum

NOVEMBER 4, 2020

It may not be appropriate to use the word ‘failure’ when summarising the utility of clinical trials in the search for a curative or preventative treatment for disease. Most of the trials are underpowered to demonstrate efficacy on mortality and long-term consequences of the disease.

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Clinical Trials Clinical Trials Trials Vaccination 105

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

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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

AUGUST 14, 2023

The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight deadlines. The clinical trial process is both expensive and time-consuming, and ends more often in failure than success. Advarra surveyed 1,000 random U.S. In total, 82.8%

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Clinical Trials Clinical Trials Trials Clinical Research 52

pharmaphorum

SEPTEMBER 18, 2020

Roche’s Actemra may help fight pandemic after all with phase 3 trial results showing it cut the chances of COVID-19 patients, mainly from higher risk minority ethnic backgrounds with pneumonia, progressing to mechanical ventilation or death. in the Actemra arm versus 19.3% in the placebo arm. in the Actemra arm versus 19.3%

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XTalks

AUGUST 4, 2022

Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. In the same webinar, Dr. Hansie M.

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Clinical Trials Clinical Trials Trials Clinical Research 52

pharmaphorum

DECEMBER 17, 2020

UK-based EUSA Pharma has begun a late-stage trial of its antibody siltuximab in COVID-19, hoping that the IL-6 inhibitor will succeed where class rivals from Roche and Sanofi/Regeneron have failed. Patients selected will be in a hyperinflammatory state that will most likely benefit from the addition of an immunomodulator, such as siltuximab.

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Drugs Immune Response Trials Clinical Trials 103

Cloudbyz

AUGUST 25, 2020

A virtual clinical trial, also known as a decentralized clinical trial, is comparatively a new method of conducting clinical trials virtually. In a true sense, a virtual clinical trial has no physical interaction during the entire process. are used extensively during a remote clinical trial.

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Trials Clinical Trials Clinical Trials Clinical Research 63

pharmaphorum

AUGUST 17, 2022

Sanofi has called time on breast cancer candidate amcenestrant – at one time one of its top pipeline prospects – after it missed the mark in another clinical trial. ESR1 mutations are seen in patients who have developed resistance to aromatase inhibitors, which might indicate SERDS will have greater utility in a second-line setting.

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Cloudbyz

APRIL 16, 2023

Clinical trial management systems (CTMS) are software solutions designed to help manage clinical trials. They provide a range of tools for study management, including tracking patient recruitment, monitoring data, and managing study budgets. Cost The cost of the CTMS is also an important factor to consider.

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Clinical Trials Clinical Trials Trials Laboratory Information Management System 52

Cloudbyz

MAY 15, 2023

Clinical trials play a critical role in medicine and healthcare, offering valuable insights that inform treatment options, drug development, and patient care. As such, the integrity of data collected during these trials is paramount. Audits can reveal systemic issues and provide opportunities for improvement.

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Clinical Trials Clinical Trials Trials Compliance 69

The Pharma Data

JANUARY 20, 2021

Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial.

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pharmaphorum

AUGUST 19, 2022

Reeling from the recent failure of its lead product in a pivotal trial, Nordic Nanovector has formally started a restructuring process and called in investment bank Carnegie to help explore its options.

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Clinical Trial Podcast

JULY 18, 2020

Have you been tasked to develop a clinical trial budget? Well, you’re in luck because I’m going to share everything you need to know about clinical trial costs. Clinical trial budgets are often put together in haste. Developing a clinical trial budget can be a confusing exercise for sponsors and CROs.

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Clinical Trials Clinical Trials Trials Clinical Research 98

pharmaphorum

AUGUST 22, 2021

Alexion has dropped development of its Ultomiris drug in amyotrophic lateral sclerosis (ALS), chalking up the first clinical failure for the drug since AZ took control. A phase 3 trial in NMOSD completed recruitment in March. Positive results in gMG were reported last month, with regulatory filings se to follow shortly.

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Trials Development Clinical Trials Clinical Trials 59

VirTrial

APRIL 3, 2020

Clinical studies are carefully designed to address the unique needs of not only the sponsor, but more importantly, the patients that commit to participate. A cardiovascular outcome trial (CVOT), for example, requires a long duration (potentially up to five years) in order to effectively evaluate real-life, long-term outcomes.

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pharmaphorum

AUGUST 31, 2021

For the healthcare ecosystem to drive research and care, clarity is needed about the opportunities and challenges of ECAs and their value in bringing therapies to patients faster, say COTA Viraj Narayanan and Karla Feghali from ConvergeHEALTH by Deloitte. Myth 2: Implementing an ECA requires too much money, time and resource.

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Clinical Trials Clinical Trials Life Science Trials 70

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.

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Clinical Trials Clinical Trials Trials Research 52

The Pharma Data

JANUARY 18, 2021

The independent Data Monitoring Committee (DMC) of the COVA study recommends start of recruitment of Part 2 of the two-part Phase 2-3 Study (“the COVA Study”). Patient recruitment for Part 2 of the COVA Study will start as soon as regulatory/ethics approvals or permissions are obtained in the relevant jurisdictions.

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Drug Discovery World

FEBRUARY 29, 2024

JP: At the end of the day, what matters to patients is all that matters. But while drug discovery ends in patients, it begins in cells and mice. Curing cells and mice doesn’t always help patients, but it predicts if new drugs are likely to be harmful or helpful. MT: In what ways can human data benefit neurology drug discovery?

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Drugs Genome Genomics Genetics 59

pharmaphorum

OCTOBER 1, 2020

Running clinical trials costs a lot of money! Many clinical trials fail. For example, it can be difficult to recruit patients or they may drop out during the trial. Automation can mean the difference between failure and success! What is meant by automating clinical trials?

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Clinical Trials Clinical Trials Trials Production 111

pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. Source: Izmailova et al, 2017.

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Clinical Trials Clinical Trials Trials Regulation 83

FDA Law Blog

MAY 3, 2021

On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The ClinicalTrials.gov database is a public database of clinical studies administered by the U.S. The notice was given to Acceleron Pharma, Inc., National Library of Medicine.

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Clinical Trials Clinical Trials Trials Regulation 52

Advarra

JUNE 14, 2022

Pre-screening potential participants for a clinical study is common practice at most research sites. Often, low accrual or delays in clinical trials stem from an undersized pipeline of potential participants. Here’s why that’s a mistake — and why pre-screening is the great missed opportunity for modern day trial enrollment.

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Trials Clinical Trials Clinical Trials Research 52

pharmaphorum

AUGUST 25, 2022

That is a moral failure on the part of medicine. But herein lies the dichotomy that medicine has created: By failing to regularly screen to find the early-stage disease, the number of patients who could participate in drug trials is limited. That makes recruitment of patients more challenging.

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pharmaphorum

OCTOBER 27, 2021

As part of an approval statement , the agency noted that the decision was taken on a surrogate endpoint, wherein the treatment managed to display a reduction in amyloid beta plaques in the brain of patients treated with Aduhelm. The challenge of treating Alzheimer’s. The next treatment for Alzheimer’s.

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Clinical Trials Clinical Trials Trials Research 75

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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Clinical Research Research Clinical Trials Clinical Trials 105

pharmaphorum

DECEMBER 15, 2021

In the pharma industry, “patient engagement” and “patient centricity” might seem like interchangeable bits of corporate jargon. Going from the vital activity of patient engagement to the more encompassing state of patient centricity requires big steps in the evolution of new-drug discovery, development, and delivery.

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The Pharma Data

DECEMBER 23, 2020

23, 2020 — Because COVID-19 is known to raise the odds for dangerous blood clots, blood thinners have quickly become part of routine care for many hospitalized patients. National Institutes of Health (NIH), the finding is limited to COVID-19 patients who are so sick they require care in the intensive care unit (ICU).

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Trials Clinical Trials Clinical Trials Medicine 52

FDA Law Blog

MAY 3, 2021

Butler — On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The ClinicalTrials.gov database is a public database of clinical studies administered by the U.S. The notice was given to Acceleron Pharma, Inc., 42 U.S.C. §

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