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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Outsourcing Pharma

APRIL 6, 2023

TWO US clinical investigator sites have been opened for a phase 1 clinical trial for patients with soft tissue sarcoma and the first patient has been dosed.

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pharmaphorum

MAY 7, 2021

Proceeds from the fundraiser will go towards the phase 1/2a clinical trial the company began in February this year of the lead candidate codenamed SPL026. 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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Worldwide Clinical Trials

NOVEMBER 3, 2022

In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. Ansel said he’s seen an increase in the number of sponsors coming to Worldwide Clinical Trials for exactly that purpose. And it takes time to get right.

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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. The post A collaborative approach to greater diversity in clinical trials appeared first on.

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Scienmag

DECEMBER 20, 2021

A clinical trial in which two test drugs failed to help patients with mild COVID-19 nevertheless had a silver lining: It proved the viability of a study model in which a medication’s potential arrhythmic side effects are safely, effectively monitored without the participants ever setting foot in a hospital or clinic.

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pharmaphorum

JANUARY 19, 2021

A survey by rare disease patient network Raremark found that 86% of the community members asked were interested in taking part in clinical trials. CEO Jeremy Edwards looks at how decentralised trial models can solve some of the challenges for clinical trial recruitment in rare disease.

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ACRP blog

JUNE 22, 2022

“Thanks to clinical trials and the grace of God, I’m alive today,” says Rhonda Long, who has battled a rare bile duct cancer for years. “A The next step was a clinical trial,” Long says, and was lucky when her oncologist found where she was eligible. “It I could continue my drug trial and treatment,” he says.

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STAT News

MARCH 27, 2023

The agency proposed that companies conduct randomized controlled trials in which patients receive either a therapy or another alternate treatment instead of trials that test the drug without a comparator, known as single-arm studies. Continue to STAT+ to read the full story…

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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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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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Placebo Control

AUGUST 7, 2013

With the activation of our Comparator Network the participating TransCelerate companies will be able to source these comparator drugs directly from each other, be able to secure supply when they need it in the quantities they need, have access to drug data and totally mitigate the risk of counterfeit drugs in that clinical trial."

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Scienmag

JUNE 15, 2022

A novel staging framework that assesses the progression of Huntington’s disease (HD), similar to the way cancer is staged 0 to 4, has been developed by UCL scientists as part of an international consortium; this ‘significant’ step paves the way for clinical trials of drugs in the earliest phase of disease.

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pharmaphorum

AUGUST 6, 2020

The post Lundbeck gets cold feet, axes schizophrenia drug trial appeared first on.

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STAT News

SEPTEMBER 30, 2022

… The results of a key Alzheimer’s drug trial on Wednesday have reignited decades-old hopes that targeting amyloid beta helps arrest the progression of the fatal brain disease, giving a big boost to similar studies being run by Roche and Eli Lilly , Reuters explains. Meanwhile, keep in touch.

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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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Trials Drug Trials Drugs Research 68

pharmaphorum

OCTOBER 27, 2020

The effect of failing to include women proportionately in clinical trials may have consequences for the quality of medical care women receive, with therapies, doses and risk assessment tools being tailored to the male population”. The impact of underrepresenting women.

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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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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. VirTrial is a bioscience technology company providing a stable, long-standing telemedicine platform to transform the clinical trial industry.

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NY Times

FEBRUARY 10, 2022

The panel debated whether overseas trials could be applied to a more diverse U.S. The decision may affect other Chinese drug trials, and spotlights the high cost of immunotherapy. population.

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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 “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a). 42 U.S.C. §

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ACRP blog

DECEMBER 1, 2022

From 2018 to 2020, the number of active clinical investigators (including those conducting medical device studies) was 45,554, with 83% of them having worked on pharmaceutical clinical trials. Most investigators during the three-year period we examined most closely have little clinical trial experience,” Glass explained.

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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. Food and Drug Administration (FDA) approval.

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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 “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a). 42 U.S.C. §

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Clinical Trials Clinical Trials Trials Regulation 40

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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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

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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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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XTalks

OCTOBER 7, 2024

Takeda has forecasted continued financial pressure but is banking on new drug trials to stabilize its position​. Clinical t rial f ailures: Amylyx’s large-scale layoffs underscore the heavy dependence some companies have on a single product.

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XTalks

MAY 16, 2023

Clinical trials for pulmonary fibrosis are being conducted to evaluate the effectiveness of novel therapies and interventions, providing hope for improved outcomes in the future. Anti-fibrotic therapies: Anti-fibrotic drugs have shown promise in treating pulmonary fibrosis.

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Clinical Trials Clinical Trials Trials Research 98

Velocity Clinical Research

OCTOBER 21, 2024

At the beginning of September, Velocity Clinical Research topped Business North Carolina ’s 2024 Fast 40 list. For a clinical trials organization to achieve this level of scale is notable. Recruitment Clinical trial sites live and die by their ability to recruit patients into trials.

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XTalks

SEPTEMBER 11, 2020

Expanding minority Americans’ access to care and clinical trials isn’t just the right thing to do. Clinical Trials Don’t Reflect Demographics. Disease doesn’t discriminate, and researchers understand different populations react differently to drugs. Why, then, are clinical trials so stubbornly homogeneous?

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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. The Diversity of the US Population.

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Clinical Trials Clinical Trials Trials Clinical Research 52

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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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. We need to talk more about clinical trials to understand terms and reassure a public that is skeptical of new drugs. The media stories about the FDA.

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pharmaphorum

MAY 14, 2021

Kintor posted a press release at the end of April to announce that phase 3 clinical development had begun and since then it has seen its share price rise considerably on the Hong Kong stock exchange. 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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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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