Rethinking Clinical Trials

MAY 21, 2024

May 19, 2024: The NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop at the 2022 Health Care Systems Research Network (HCSRN) Annual Conference. Workshop Summary & Additional Resources Agenda and Slides Welcome and Introduction Emily O'Brien, PhD Session 1: What Are Embedded PCTs (ePCTs)?

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Clinical Trials Clinical Trials Trials Research 100

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 10, 2022

This means that if someone drinks 50 ml of 40 percent spirits, which contains […]. It is marketed by Swedish firm Myrkl as “the pre-drinking pill that works” The pill is said to break down up to 70 percent of alcohol after 60 minutes.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 17, 2024

A new drug called kush is wreaking havoc in west Africa, particularly in Sierra Leone where it is estimated to kill around a dozen people each week and hospitalise thousands. The drug, taken mostly by men aged 18 to 25, causes people to fall asleep while walking, to fall over, to bang their heads against […]

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Containment Drugs Clinical Trials Clinical Trials 130

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 17, 2023

The pill, called Opill – the brand name for the tablet formulation of norgestrel – is an oral contraceptive containing only progestin hormone, which helps prevent pregnancy […]

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Hormones Containment Branding Drugs 230

pharmaphorum

JANUARY 14, 2022

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.

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Clinical Trials Clinical Trials Trials Clinical Research 126

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 25, 2023

The Indian Council of Medical Research (ICMR) has invited Expression of Interest (EoI) through email from experienced Indian agencies for undertaking Transfer of Technology for commercialization and marketing of multiplex single tube real time RT PCR assay for detection of Influenza A , B and SARS CoV2.

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Containment Marketing Research Clinical Trials 188

XTalks

OCTOBER 24, 2024

Trends in Psoriasis Research: Biologics, Biosimilars and New Therapies Recent innovations in biologics and biosimilars have transformed psoriasis care. In August 2024, Artax Biopharma completed patient recruitment for its Phase IIa trial of AX-158, exploring a new immune-modulating therapy for psoriasis.

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Research Dermatology Clinical Trials Clinical Trials 105

Pharmaceutical Technology

APRIL 14, 2023

R21 contains Matrix-M, a saponin-based adjuvant from Novavax which makes the vaccine more potent and durable by enhancing immune system response. The WHO, which has already recommended GSK’s RTS,S/AS01 malaria vaccine , is yet to recommend Oxford’s R21 vaccine.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 2, 2024

The zest of oranges has now been found to contain a novel, bioactive compound, called feruloylputrescine (FP), that could benefit heart health when eaten. The bitter peel of an orange is there to protect the fruit, and it could protect our own insides, too, if only we stopped throwing the rinds away. Its discovery in […]

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Containment Clinical Trials Clinical Trials Clinical Research 188

Pharmaceutical Technology

AUGUST 24, 2022

Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies. A central lab with a global footprint provides both the efficient transportation arrangement and scientific rigor required to unlock the valuable information contained within patients’ biological samples.

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Clinical Trials Clinical Trials Trials Development 130

pharmaphorum

NOVEMBER 28, 2021

An investigator-led trial of Jazz Pharma’s cannabis extract-based drug Sativex in glioblastoma – an aggressive form of brain cancer – will get underway in the UK next year. The post Trial of Jazz’ cannabis drug in glioblastoma will start next year appeared first on.

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Trials Drugs Clinical Trials Clinical Trials 136

Rethinking Clinical Trials

SEPTEMBER 13, 2023

The DEVICE trial hypothesized that the use of a video laryngoscope will increase the incidence of successful intubation on the first attempt. The trial operated under an IRB waiver of informed consent with a patient information sheet. Discussion Themes -Why did the RSI trial follow a different path – not a waiver of consent?

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Trials Clinical Trials Clinical Trials Medicine 113

XTalks

MAY 4, 2023

When a person with celiac disease eats something that contains gluten, their immune system attacks their small intestine, damaging the lining and interfering with the absorption of nutrients from food. However, there are ongoing clinical trials for celiac disease to investigate potential new treatments.

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Clinical Trials Clinical Trials Trials Immune Response 98

Pharmaceutical Technology

FEBRUARY 26, 2023

Finch Therapeutics’s Phase III PRISM4 trial for recurrent Clostridioides difficile infection (CDI) and MaaT Pharma’s Phase III trial in steroid-resistant acute graft-versus-host disease were both put on hold. While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. with placebo.

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Bacteria Trials Research Medicine 278

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 29, 2023

The Drugs Technical Advisory Board (DTAB) has recommended to get comments and inputs from Indian Council of Medical Research (ICMR) for further action on restricting Nicotine Replacement Therapies (NRTs) containing upto 2 mg or 4 mg only through prescription of authorised medical practitioners, as proposed by the Tobacco Control Division (TCD).

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Containment Drugs Research Clinical Trials 161

World of DTC Marketing

DECEMBER 13, 2021

Containing cancer and killing those abnormal cells without damaging nearby healthy cells often requires a range of treatments over an extended period of time — lengthy radiation, complicated surgeries, costly chemotherapy, plus other strong medications to supercharge your immunity. Research shows most cancers are preventable.

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Drugs FDA Approval Medicine Containment 55

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 20, 2024

The drug control department in Tamil Nadu will soon introduce an action plan to contain antimicrobial resistance (AMR), and a stakeholders meeting is likely to be held very soon, It is learnt from reliable source that in the state action plan, the drug control department will have a significant role in implementing the programmes.

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Containment Drugs Clinical Trials Clinical Trials 164

pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.

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Vaccination Vaccine Trials Protein 104

Crucial Data Soutions

DECEMBER 15, 2020

Someday, clinical and post-market research will be 100 percent remote. But in fact, ‘someday’ in the clinical research space is now. Read on to discover how these concepts are made possible – and practical – today by applying technology to work for rather than against research professionals and patients. .

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Clinical Trials Clinical Trials Trials Clinical Research 105

pharmaphorum

AUGUST 6, 2021

Patient enrollment is a common issue across many therapeutic areas in clinical research. Psychiatric disorders in particular represent a trial area with significantly high drop-out rates and poor patient recruitment. Psychiatric disorders have historically had great difficulty onboarding and retaining patients for clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 105

Worldwide Clinical Trials

FEBRUARY 21, 2024

Regardless of the formulation, the entire dose must be administered to each subject, and the dosing containers must be checked for residual radioactivity. The post Why Proactive AME Studies are Critical to Accelerating Your Approval Journey appeared first on Worldwide Clinical Trials.

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Clinical Trials Clinical Trials Pharmacy Trials 200

World of DTC Marketing

NOVEMBER 27, 2020

A report released Thursday by the University of California at Los Angeles researchers said that 66 percent of Los Angeles health-care workers who responded to an online questionnaire (not a randomized sample) said they would delay taking a vaccine. The results of trials were announced in press releases rather than peer-reviewed papers.

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Vaccination Vaccine Pharma Companies Trials 208

Cloudbyz

JUNE 16, 2023

Clinical trials are crucial for advancing medical research and developing innovative treatments. Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. Data Complexity: Clinical trial data often comes in diverse formats, such as text, images, audio, and video.

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Clinical Trials Clinical Trials Compliance Trials 94

Pharmaceutical Technology

SEPTEMBER 14, 2022

Successful TIL therapy depends on the infusion product containing tumour-reactive T cells that, on infusion, generate an anti-tumour immune response that causes disease regression. Improvement to the TIL product itself is an area of intense research. However, none of these studies has included a standard of care (SOC) control arm.

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Immune Response In-Vivo Production Manufacturing 246

XTalks

NOVEMBER 29, 2022

Xtalks interviewed Devon Adams to learn more about his work related to decentralized oncology trials as a senior analyst for legislative policy specific to clinical trials at the ACS CAN. Read on to learn more! Over 1,100 cancer patients and cancer survivors responded.

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Trials Clinical Trials Clinical Trials Development 98

Pharma Mirror

FEBRUARY 18, 2022

From research to clinical trials, to go-to-market, drug makers are constantly seeking out new drug technologies and approaches to treat everyday illnesses and to end global pandemics. But the vials and containers that deliver these drugs haven’t evolved at nearly the same rate.

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Packaging Packaging Drugs Clinical Trials 130

Imperical Blog

DECEMBER 4, 2024

Clinical trial kits, which contain necessary items for site visits like sample tubes, labels, and instructions, all conveniently customized by trial and visit, are a staple of clinical trials. Read on… The post Clinical Trial Kitting: Avoid Costly Pitfalls appeared first on Imperial Clinical Research Services Blog.

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Clinical Trials Clinical Trials Trials Clinical Research 52

Pharmaceutical Technology

APRIL 28, 2023

It has also been approved by the FDA for otitis media prevention in infants and children aged between six weeks and five years caused by the original seven serotypes contained in PREVNAR. The latest approval is based on data obtained from the Phase II and Phase III trials of PREVNAR 20 for paediatric indication.

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Pharmaceutical Technology

AUGUST 5, 2022

This is also why academic research is dominant here, as companies are hesitant to take this on, adds Holger Wille, PhD, associate professor at the Centre for Prions and Protein Folding Diseases at the University of Alberta. Adding to this, the infectivity of prion diseases also makes research challenging, says Wille.

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Drugs Protein Vaccination Vaccine 299

XTalks

MAY 7, 2021

Novavax published the latest results from a Phase IIb clinical trial conducted in South Africa evaluating the safety and efficacy of NVX-CoV2373, appearing in the NEJM ’s May 6, 2021 issue. Earlier results from a more complete analysis of trial data shared in March confirmed a high level efficacy of 86.3 1.351 variant.

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Protein Vaccination Vaccine Trials 97

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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Packaging Packaging Marketing Clinical Trials 100

Rethinking Clinical Trials

AUGUST 3, 2023

Bergstrom, PhD Professor, Department of Biology University of Washington Slides Keywords Research, Misinformation, Media, Social Media Key Points Misinformation abounds in medicine and about medicine. As researchers, we are producers and consumers of the medical literature. Researchers need to understand how preprints are received.

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Medicine Research Vaccination Vaccine 100

XTalks

APRIL 24, 2023

Rare disease clinical trials are complex due to the additional scientific, medical, operational and regulatory requirements of newly emerging advanced therapies, such as gene therapy,” says Dr. Terence Eagleton, MB BS, Senior Medical Director at the global clinical research organization (CRO) Medpace. Reference: Chung DC, et al.

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Gene Therapy Gene Trials Clinical Trials 95

Rethinking Clinical Trials

JULY 10, 2023

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee Meeting in May, Keith Marsolo, PhD, Co-Chair of the Electronic Health Records Core , reflected on data sharing experiences from the program and factors affecting the meaningful re-use of data. Most studies have only had one or two requests for data.

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Trials Clinical Trials Clinical Trials Containment 130

ProRelix Research

APRIL 18, 2024

According to the National Cancer Institute (NCI), a solid tumour is a mass of tissue that usually does not contain cysts or liquid areas such as sarcomas (arising from connective […] The post The Promise of Clinical Trials in Advancing Solid Tumour Cancer Treatments appeared first on ProRelix Research.

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Clinical Trials Clinical Trials Trials Containment 52

pharmaphorum

JANUARY 18, 2023

The DNA of these so-called ‘genetic superheroes’ may contain clues about how to treat severe disease. The idea of ‘genetic superheroes’ and precision medicine is captivating for researchers, but the concept can be abstract and distant for participants. Why should research be any different? with their priorities.

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Genetic Disease Genetics Research Genomics 97

Pharmaceutical Technology

SEPTEMBER 14, 2022

Pharmaceutical drug research and development (R&D) activities are capital-intensive, which makes the outsourcing of clinical dose manufacturing and marketing popular. The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing or hiring decision.

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Marketing Contract Manufacturing Sales Clinical Trials 100