Delveinsight

AUGUST 13, 2021

Clinical trials are an essential part of the drug development process. Worldwide, more than 2 million clinical trials are registered and the number is steadily increasing over the past several years. The conduct of trials was not possible due to the risk of catching coronavirus. What are Virtual Clinical Trials?

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pharmaphorum

AUGUST 6, 2020

Lundbeck has axed a phase 2 trial of a schizophrenia drug, saying that the study was unlikely to meet its efficacy target. The company said it made the decision after a futility analysis indicated that the trial was not likely to succeed, when measured against a standard scale.

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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.

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World of DTC Marketing

APRIL 20, 2022

Attitudes are indeed changing, but one need remains clear: access to data obtained during clinical and ongoing trials. The feedback suggests that pharma has significant opportunities to get closer to HCPs via more transparency about drug trials and data. Will they transform their HCP marketing or stick to dated models?

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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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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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Clinical Trials Clinical Trials Trials Vaccination 122

Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Finding the best clinical trial packaging services providers.

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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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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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XTalks

FEBRUARY 25, 2022

There has been increasing awareness around the need for improving inclusion and diversity in clinical trials. Despite these statistics, in the US, Black people only constitute five percent of all clinical trial participants. The overwhelming majority of trial participants nationwide are white. Medical Mistrust.

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Clinical Trials Clinical Trials Trials Research 52

Pharmaceutical Technology

SEPTEMBER 7, 2022

Pharmacovigilance refers to the practice of collecting, detecting, assessing, monitoring and preventing adverse effects (AEs) caused by new drug substances. For multinational translation company RWS, processing vastly scaled-up numbers of AEs required the company to redesign its workflow in order to stay ahead of the curve.

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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

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

AUGUST 4, 2020

New research looks at the factors that speed up and slow down HTA appraisals for rare disease medicines across Europe. Rare diseases drugs have always faced challenges when it comes to HTA approvals, even as governments bring in more regulatory policies that make their path through assessment easier. Rates of approval.

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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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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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The Pharma Data

NOVEMBER 10, 2020

Biomarkers will be critical to developing precision medicine for Alzheimer’s disease. 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.

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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. National Library of Medicine. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 U.S.C. §

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Clinical Trials Clinical Trials Trials Regulation 52

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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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. Which leads to two questions: 1.

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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. National Library of Medicine. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 U.S.C. §

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Clinical Trials Clinical Trials Trials Regulation 40

The Pharma Data

AUGUST 16, 2020

“Historically medical education was designed and written by white middle-class men, and so there is an inherent racism in medicine that means it exists to serve white patients above all others,” he said. Teaching on the history of medicine, including the exploitation of people of colour in scientific research.

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Pharmaceutical Technology

APRIL 27, 2023

Genomic medicine development was ranked as the top industry trend for 2023 in a survey of 198 GlobalData Pharma clients and prospects conducted between October and November 2022. Excluding vaccines, there are five mRNA therapeutic products in clinical trial development as of November 2022. billion by 2028.

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