Sat.Feb 24, 2024 - Fri.Mar 01, 2024

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Overcoming Public Skepticism In Clinical Trials

Imperical Blog

With more than 65,000 clinical studies currently recruiting, our industry is constantly working hard to enroll participants and meet study timelines. Unfortunately, public skepticism in clinical trials can get in the way of those efforts. People enroll in studies for a variety of reasons, from… The post Overcoming Public Skepticism In Clinical Trials appeared first on Imperial Clinical Research Services Blog.

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Cancer Professional and Survivor: ‘Without Clinical Trials, People Like Me Would Have No Hope’

ACRP blog

If there wasn’t already a general awareness among the personnel of the Penn State Cancer Institute Clinical Trials Office that February is National Cancer Prevention Month , you may guess the fact that breast cancer survivor Doris Shank, BSN, MSN, administrative director of the office, is preparing for her second cancer-related surgery soon has brought the topic of prevention to mind for some of them in any event.

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How to evaluate ePRO vendors for your clinical trial

Antidote

Electronic patient-reported outcomes ( often abbreviated to ePRO ) are tools intended to collect patient data in clinical trials through methods such as diaries, phone apps, tablets, and other devices. These tools are useful for streamlining the work required by site staff and also create a more patient-centric environment in clinical trials.

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Planning strategies for transitioning to the Clinical Trials Regulation

pharmaphorum

There is a pressing need for companies to transition their EU clinical trials that are ongoing under the “old” regulatory framework of the Clinical Trials Directive to the Clinical Trials Regulation. The risk for those that don’t meet the 30th January 2025 deadline for transition is that they will lose their legal basis.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Survey reveals insights into physicians' perspectives on clinical trials and digitalization

Outsourcing Pharma

Last week (February 22), it was announced a recent survey conducted jointly by Climedo and Siteworks has shed light on the perspectives of more than 65 primarily European-based study physicians.

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Pharmaceuticals export grows 6.8% in January

AuroBlog - Aurous Healthcare Clinical Trials blog

Exports of drugs and pharmaceuticals during the month of January posted a growth of 6.84 per cent as compared to the same month of previous year. For the first 10 months of the current fiscal year pharma exports grew 8.07 per cent, according to the Central government.

Drugs 150

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Leveraging AI-Enabled Data Extraction to Accelerate Case Processing in Clinical Trials

Cloudbyz

In the dynamic landscape of pharmacovigilance, where timely and accurate data processing is paramount, the integration of artificial intelligence (AI) technologies has emerged as a game-changer. AI-enabled data extraction holds immense promise in expediting case processing within clinical trials, offering a transformative approach to streamline workflows and enhance efficiency.

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Rare Disease Day: Enhancing clinical trial success in rare diseases

pharmaphorum

Rare Disease Day is an opportunity to highlight the importance of enhancing clinical trial success in rare diseases for the benefit of patients.

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Podcast: Celebrating Excellence in Patient Centricity (With Sanofi and SCRS)

Velocity Clinical Research

“[Patient centricity] is about taking those patient insights and their voice and translating them into actions. And that was really the impetus for what we saw in Velocity’s submission.” – Pat Roselle, Global Head of Patient Stakeholder Engagement at Sanofi. Thank you to Pat and Jimmy Bechtel for joining Nick Spittal to discuss the initiatives that earned Velocity the 2023 Society for Clinical Research Sites (SCRS) Excellence in Patient Centricity Award.

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India’s Tata Institute develops tablet for cancer recurrence prevention

Pharmaceutical Technology

India’s Tata Institute has developed a tablet combining resveratrol and copper that has the potential to prevent the recurrence of cancer.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Viking data suggest obesity drug could rival Zepbound, Wegovy

Bio Pharma Dive

The biotech’s drug led to significant weight loss in a Phase 2 trial, causing shares to double as analysts compared results to the marks set by drugs from Eli Lilly and Novo Nordisk.

Drugs 310
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California Man Free of HIV And Cancer in Astonishing Medical Recovery

AuroBlog - Aurous Healthcare Clinical Trials blog

On the list of illnesses that nobody wants, cancer and HIV both rank pretty high, and Californian man Paul Edmonds had both. But ever since one particular treatment five years ago, he’s been free of both cancer and HIV.

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Considering Master Protocol Use in Your Trial: Evaluating Basket and Umbrella Trial Designs

Worldwide Clinical Trials

With cost and timelines being two of the most significant factors influencing a study’s progression aside from efficacy and safety, master protocols offer an attractive option for study design. These designs facilitate streamlined trial logistics and centralized governance and create higher-quality data. But how do they work, and when are they appropriate?

Trials 195
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Bayer wins FDA breakthrough therapy designation for NSCLC candidate

Pharmaceutical Technology

Bayer’s oral tyrosine kinase inhibitor is currently in a Phase I trial estimated to enrol 460 patients.

Trials 331
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Gritstone to lay off 40% of workforce after costly study delay

Bio Pharma Dive

The restructuring comes ahead of a key study readout for Gritstone, which, like Moderna, is developing a type of personalized vaccine for cancer.

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Simple Experiment Reveals Why Your Next Antibiotics May Prove Useless

AuroBlog - Aurous Healthcare Clinical Trials blog

Do bacteria mutate randomly, or do they mutate for a purpose? Researchers have been puzzling over this conundrum for over a century. In 1943, microbiologist Salvador Luria and physicist turned biologist Max Delbrück invented an experiment to argue that bacteria mutated aimlessly.

Bacteria 187
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ICR study reveals new targeted immunotherapy to prevent spread of breast cancer

Pharma Times

Breast cancer is responsible for around 47,000 new cases in England every year

Research 153
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Beacon Therapeutics unveils promising interim results for gene therapy AGTC-501

Pharmaceutical Technology

AGTC-501 is in Phase II development for retinitis in the SKYLINE trial (NCT03316560) and addresses unmet needs within the retinitis space

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Obesity drug from Boehringer, Zealand succeeds in MASH trial

Bio Pharma Dive

Zealand shares rose by more than one-third on the data, which provide further evidence so-called incretin drugs could help treat people with the liver disease.

Drugs 289
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Microplastics Found in Every Human Placenta Tested, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

It’s been over three years since scientists first found microplastics swimming in four different human placentas, and as it turns out, that was just the tip of the iceberg. A few years later, at the start of 2023, researchers announced they had found microscopic particles of plastic waste in no fewer than 17 different placentas.

Scientist 186
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February 28, 2024: A Randomized Trial of a Food-as-Medicine Program, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Joseph Doyle of the Massachusetts Institute of Technology (MIT) will present “Effect of an Intensive Food-as-Medicine Program on Health and Healthcare Use: Evidence From a Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, March 1, 2024, at 1:00 pm eastern. Doyle is the Erwin H.

Medicine 147
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Lutris wins FDA orphan drug tag for EGFR inhibitor-induced rash candidate

Pharmaceutical Technology

LUT014 is being investigated in an ongoing Phase II trial as a first-line treatment for EGFR inhibitor-induced acneiform rash, for which there is no approved drug.

Drugs 264
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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CDC panel mulls changes to RSV vaccine recommendation

Bio Pharma Dive

The expert committee is discussing whether, for certain older adults, to make a universal recommendation for vaccination, rather than the current policy of “shared decisionmaking.

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Tiny Doses of LSD Boost Unique Signals in The Human Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

Even small doses of LSD could have therapeutic benefits for mental health and task performance, a new study shows. Researchers from the US and Germany gave 21 adults either a placebo or 13 or 26 micrograms of LSD – small doses that rarely lead to hallucinatory effects.

Research 181
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New digital iTalkBetter app significantly improves speech in stroke patients

Pharma Times

Aphasia is a language disorder caused by some form of brain damage, including stroke

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Biotech funding optimism rises as 44% predict recovery in 2024

Pharmaceutical Technology

During 2023, funding decreased by 43.2% compared to 2022 and by 52.3% compared to 2021, attributed to macroeconomic pressures.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Pfizer, looking for a jumpstart, leans into cancer drug research

Bio Pharma Dive

Reeling from a difficult year financially, the pharma unveiled a new oncology division it says will produce eight billion-dollar medicines by 2030.

Research 232
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Panel asks govt to persuade private insurance companies to cover Ayush treatments

AuroBlog - Aurous Healthcare Clinical Trials blog

The Department-related Parliamentary Standing Committee on Health and Family Welfare has recommended to the government to persuade private insurance companies to include Ayurveda, Yoga, Unani, Siddha and Homoeopathy (Ayush) treatments in their products and look at global acceptance for these systems of medicines through legalisation and insurance support in other countries.

Medicine 165
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Pfizer fleshes out oncology strategy, targeting 8 blockbuster cancer drugs by 2030

Fierce Pharma

In what CEO Albert Bourla called an update to a top priority at Pfizer, the company on Thursday systemically laid out its new oncology strategy following the $43 billion acquisition of antibody-dru | Pfizer on Thursday systemically laid out its new oncology strategy following the $43 billion acquisition of Seagen. The company aims to have at least eight blockbuster cancer drugs by 2030, with a focus on four main cancer types.

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Pelage secures funds to develop regenerative medicine for hair loss

Pharmaceutical Technology

Pelage Pharmaceuticals has secured $16.75m in a Series A financing round to further the development of PP405 for hair loss.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.