World of DTC Marketing

APRIL 20, 2022

The feedback suggests that pharma has significant opportunities to get closer to HCPs via more transparency about drug trials and data. The most likely reason to visit a pharma website for HCPs is to download the product label. 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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Trials Drug Trials Drugs Research 68

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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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.

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Packaging Packaging Marketing Clinical Trials 100

pharmaphorum

SEPTEMBER 27, 2021

In 2020, 53 novel medicines were approved by the FDA and of the patients who took part in trials, just 8% were black and 6% were Asian. This might involve changing the conversation, that it’s for the greater good and that pharma can work in parallel with traditional medicine or techniques people more happily rely on.

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Clinical Trials Clinical Trials Trials Vaccine 122

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. The following is adapted from a presentation given by Dave Par é and Silvio Scozzari at the DIA 2022 conference.

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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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Drugs Drug Trials Trials Clinical Trials 58

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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Drugs Manufacturing Marketing Regulation 122

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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Development Drugs Trials Medicine 98

pharmaphorum

DECEMBER 1, 2022

According to the FDA’s 2020 Drug Trials Snapshot Report , only 8% of clinical trial participants are Black or African American, as compared to nearly 14% of the US population. The fact is, many minorities never learn about vital clinical trials in play, or that they’re eligible to participate.

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Clinical Trials Clinical Trials Trials Clinical Research 111

Pharmaceutical Technology

JUNE 15, 2023

AI can also speed up crucial steps in the pharma R&D process, such as the discovery process for novel drug compounds or the design of clinical drug trials. Personalized medicine Every patient has unique needs and challenges, which adds to the difficulty in testing treatment effectiveness.

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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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Delveinsight

AUGUST 13, 2021

The conduct of trials was not possible due to the risk of catching coronavirus. At the same time, some pharmaceuticals, due to the priority to develop therapeutics and preventive medicines for COVID-19, had put ongoing trials for other indications at the backfoot.

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Clinical Trials Clinical Trials Trials Drugs 98

Advarra

JUNE 27, 2023

The Importance of Clinical Research in Medical Advancements Researchers use clinical trials to test a drug’s or other medical treatment’s safety and efficacy. Most modern medicines were developed from clinical trials , and clinical trials remain essential for drug development.

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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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Clinical Trials Clinical Trials Trials Antibody 52

Advarra

AUGUST 16, 2022

That is part of the responsibility of the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). Department for Health and Human Services (DHHS), prepared guidance on expedited programs for sponsors of orphan drug trials. These centers, in conjunction with the FDA and U.S.

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Clinical Trials Clinical Trials FDA Approval Drugs 52

Placebo Control

JULY 14, 2015

pic.twitter.com/dqmWPpxPdE — Adam Feuerstein (@adamfeuerstein) July 14, 2015 In another tweet, he suggests that the act will "decimate" informed consent in drug trials. Unbelievable but true if #Path2Cures becomes law. In practice, this is an especially difficult set of criteria to meet for most studies.

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FDA Law Blog

MAY 3, 2021

for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). National Library of Medicine.

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Clinical Trials Clinical Trials Trials Regulation 52

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. 1001566.

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FDA Law Blog

MAY 3, 2021

for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). National Library of Medicine.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Regulation 40

XTalks

FEBRUARY 25, 2022

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. Race-Based Medicine. Personalized Medicine. However, the links between race-based genetics and disease are not quite clear.

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Clinical Trials Clinical Trials Trials Research 52

XTalks

AUGUST 4, 2022

This started back in 1993 when the FDA established guidelines to increase diversity by gender and race/ethnicity of participants in clinical trials that were contributing to new drug approvals. In January 2015, the FDA implemented its Drug Trials Snapshots program to make clinical trial demographic data more transparent and available.

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Clinical Trials Clinical Trials Trials Clinical Research 52

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. The risk of contamination is particularly important for genomic medicines in which trace amounts of nucleic acids would impact the quality of the drug product.

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