STAT News

MARCH 29, 2023

Lupus is a disease long-plagued by failed clinical trials. And hopeful patients, many of them young women of color, are waiting — just three lupus drugs have been approved by the Food and Drug Administration in six decades. A key partnership is looking to change that.  

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STAT News

FEBRUARY 17, 2023

Pfizer and partner Valneva are scrapping data from roughly half of the participants in a Phase 3 trial of a Lyme disease vaccine candidate after uncovering quality issues with a third-party clinical trial operator.

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Scienmag

JANUARY 19, 2022

New research suggests manufacturers of newly developed antidepressant drugs have become more forthcoming about clinical trials that don’t pan out.

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STAT News

DECEMBER 2, 2022

And a fragmented clinical trials industry has made it a prime target for private equity, which often consolidates markets by merging companies. To date, 11 of the 25 private equity firms identified by industry tracker PitchBook as the top investors in health care have bought stakes in clinical research companies.

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Worldwide Clinical Trials

NOVEMBER 3, 2022

BioPharma Dive interviewed our Derek Ansel on how to conduct psychedelic clinical research. In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. Above all: Bringing more diversity to clinical trials is a slow process.

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pharmaphorum

MAY 7, 2021

Small Pharma is following the trend for development of psychedelic medicines, a field where research has been suppressed for years because of legal restrictions on use of these compounds in many countries. The goal of the trial is for proof of concept of the drug as a wrap-around therapy for Major Depressive Disorder.

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pharmaphorum

JANUARY 18, 2021

The need for diversity in clinical trial populations has been a topic of discussion across regulators and the industry in general for decades. Fundamental barriers and deeply rooted mistrust of medical research motives among communities of colour require a more thoughtful and deliberate approach to participant outreach.

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Pharmaceutical Technology

SEPTEMBER 20, 2022

Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research. Finding the best clinical trial packaging services providers. Clinical trial packaging and labelling solutions.

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pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

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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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XTalks

FEBRUARY 25, 2022

There has been increasing awareness around the need for improving inclusion and diversity in clinical trials. As such, there has been a growing emphasis on efforts to achieve better and more accurate representations of minority and underrepresented populations like Black people in clinical studies.

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VirTrial

MAY 26, 2020

Scottsdale, AZ (May 26, 2020) – VirTrial today announced a new service designed to enable virtual site monitoring visits in the clinical trials industry. The solution enables pharmaceutical sponsors and CROs to evaluate, qualify and routinely monitor research sites for studies without physical travel.

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pharmaphorum

SEPTEMBER 27, 2021

As people have become more conscious and vocal about diversity and inclusion, Page & Page’s Lisa Lishman says pharma should reassess how it conducts clinical trials. The pharmaceutical industry is one of the most important industries in the world, providing lifesaving drugs and treatment to people who need it the most.

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Advarra

JUNE 27, 2023

Clinical trials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. The goal is to identify safer, more effective methods of treating illnesses using new drugs or new combinations of existing drugs.

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pharmaphorum

OCTOBER 27, 2020

Analysing real-world health data could help overcome the bias towards men in traditional medical research, says Sensyne Health’s Dr Lucy Mackillop. Medical research has often focused on men, meaning that the insights gained have not always been reflective of how women would react to a treatment or disease.

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pharmaphorum

MAY 14, 2021

China’s Kintor Pharmaceutical has begun late-stage US clinical development of its potential COVID drug proxalutamide – but there is scepticism over the company’s claims about its research. But Reuters reported that the doctor identified as its principal clinical trial investigator has said he is not in charge of the trial.

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Scienmag

JULY 8, 2021

Researchers, including academics from the University of York, analysed systematic reviews of 1,200 Randomised Controlled Trials (RCTs) to assess whether reporting had improved over time.

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Scienmag

JULY 18, 2021

Researchers are using computer models to simulate COVID-19 infections on a cellular level – the basic structural level of the human body. The models allow for virtual trials of drugs and vaccines, opening the possibility of pre-assessment for drug and vaccine efficacy against the virus.

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pharmaphorum

AUGUST 6, 2020

When Lundbeck began the trial at the beginning of last year, it said the drug could be a new approach to treating schizophrenia. The company hoped to tackle persistent symptoms by inhibiting the activity of the PDE10-enzyme in the brain with Lu AF11167, which was invented by Lundbeck’s in-house research operation.

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XTalks

SEPTEMBER 13, 2024

Diverse clinical trials are a matter of equity and essential for the validity and reliability of research outcomes. Historically, racial and ethnically minoritized groups or populations have been excluded from clinical trials, leading to a lack of data on how different demographic subgroups respond to treatments.

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XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease.

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ACRP blog

DECEMBER 1, 2022

In all, 80% of the nearly 37,600 PIs who were active in drug studies for some period within the 2018, 2019, and 2020 timeframe ran just one to five trials with industry funding in that three-year block. and lead author of the article due to appear in the December 2022 issue of Clinical Researcher.

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Delveinsight

AUGUST 12, 2021

The company’s founders have confirmed this role in recent research out of Beth Israel Deaconess Medical Center and Massachusetts General Hospital, LQTT said. Upon starting the phase 2 trial in March, Visus targeted the delivery of top-line data in mid-2021. Anthony Rosenzweig, M.D., David Milan, M.D., and Saumya Das, M.D.,

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Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S.

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The Pharma Data

NOVEMBER 10, 2020

Although a few are out there, phosphorylated tau (P-tau) may enable even earlier and more accurate detection, according to Eli Lilly-associated researchers speaking at the Clinical Trials on Alzheimer’s Disease (CTAD) virtual conference in early November. Jeff Dage, Ph.D.,

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pharmaphorum

AUGUST 25, 2022

At the Fatty Liver Foundation, we are formally opposed to that being the standard of care and we are working to make a difference by raising awareness, by advocating for simplification in clinical trial protocols to encourage more patient participation, and by setting up screenings for those at high-risk.

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Crucial Data Soutions

FEBRUARY 24, 2020

(CDS), a leading technology provider focused on data collection and clinical trial management, today announced several updates in celebration of its tenth anniversary, including the company’s latest technological development, TrialKit AI, a machine-learning API. About Crucial Data Solutions.

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Pharmaceutical Technology

SEPTEMBER 7, 2022

Before drugs are authorised, evidence of their safety and efficacy is limited to results from clinical trials, so it is essential that pharmacovigilance continues after a therapy has been approved. After AEs are recorded, they must be translated and put back out to doctors and scientists for processing.

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Placebo Control

JULY 14, 2015

Adam Feuerstein points out - and expresses considerable alarm over - an overlooked clause in the 21 st Century Cures Act: Waive informed consent requirement for clinical trials?!?! Even though the patients aren’t personally identifiable, the collection of medical data qualifies this as a clinical trial.

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Placebo Control

DECEMBER 4, 2013

Instead of looking at registered trials and following them through to publication, this study starts with a random sample of phase 3 and 4 drug trials that already had results posted on ClinicalTrials.gov - so in one, very obvious sense, none of the trials in this study went unpublished.

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Placebo Control

JULY 31, 2013

Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “ fake fix ” that was being thoroughly “ignored” by the pharmaceutical industry. Everyone I work with in pharma trials is painfully aware of the regulatory environment they work in.

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World of DTC Marketing

JULY 19, 2021

CDC and new drugs have fostered an era of mistrust with some people. DTC marketers need to be more forthcoming when it comes to drug trials and side effects. Scare headlines lead to clicks but people tend to skim the news rather than research headlines in depth. The media stories about the FDA.

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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. These products will require clinical trial data to get to market, but with significantly fewer participants required as compared to a drug trial.

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pharmaphorum

FEBRUARY 4, 2022

Last year, Bayer launched a project to explore the use of artificial intelligence in clinical trials, working with Finland’s Aalto University to find ways to use the technology to support decentralised trials and streamline the testing process.

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Rethinking Clinical Trials

AUGUST 4, 2022

Department of Health Research Methods, Evidence & Impact. When compared to other drug trials for COVID-19, there was a 61% reduction for the primary outcome and 54% reduction in hospitalization and death for unvaccinated populations. Glenn, MD, PhD) appeared first on Rethinking Clinical Trials. Glenn, MD, PhD.

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XTalks

OCTOBER 7, 2024

Takeda has forecasted continued financial pressure but is banking on new drug trials to stabilize its position​. The most recent layoff plan came after news in early August that Genentech was shuttering its cancer immunology group as the company reprioritized investments in cancer research.

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ACRP blog

DECEMBER 18, 2024

Medical device trials, however, are typically smaller in scale and require fewer phases [than drug trials]. The information from this site goes on to describe how medical device studies are divided into three different classes, rather than into the familiar phases of drug studies. Other Medical Devices.

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