AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 21, 2024

Few would be left untouched by the pathogen were it to gain hold, causing healthcare systems to crumble and economies to collapse as the world once again tried to contain a force of nature. […] With a fatality rate 20 times that of COVID-19, and no vaccine, Disease X could swiftly bring humanity to its knees.

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Containment Vaccination Vaccine Clinical Trials 188

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 Regulation 122

Drug Discovery World

OCTOBER 31, 2023

UK regulatory authorities have approved the first trial of a gene therapy for young children with Hunter syndrome. Following successful engraftment of modified HSCs in the bone marrow, these cells start to produce daughter blood cells which contain the IDS gene and enzyme which are distributed throughout the body, including the brain.

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Gene Therapy Gene Trials Clinical Trials 52

Drug Discovery World

APRIL 29, 2024

Dr Currien MacDonald, Medical Chair Director at WCG, discusses the challenges and opportunities presented by cannabis research. Research support Support for researching cannabidiol is expanding. More importantly, cannabis research received additional governmental support for continued investigation at the end of 2022 with H.R.8454,

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Research Drugs Production Development 59

VirTrial

NOVEMBER 29, 2023

Clinical trials demand a standardized approach to data collection, especially when it comes to patient-reported outcomes (PRO). In the ever-evolving landscape of mobile technologies, smartphones play a pivotal role in gathering crucial information from clinical trial participants. The mean usability score of 3.7/5

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Clinical Trials Clinical Trials Trials Containment 52

Rethinking Clinical Trials

DECEMBER 12, 2023

It has been studied in prior contexts in a PCORI trial and a pilot inpatient trial where the intervention increased goals of care discussions from 8% to 21%. Jumpstart is a pragmatic randomized trial of Jumpstart compared to usual care. In some previous trials we have randomized at the clinician level.

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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 130

Scienmag

JUNE 15, 2022

In a pilot study, researchers in ACS’ Journal of Agricultural and Food Chemistry report that compared to their pre-trial microbiome, men who drank either one alcoholic or non-alcoholic lager daily had […]. Like wine, beer can have health benefits when consumed in moderation.

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Containment Trials Research 59

WCG Clinical

MAY 18, 2023

Princeton, NJ – May 18, 2023 – WCG, one of the world’s leading providers of solutions that measurably improve the quality and efficiency of clinical research, today released the WCG 2023 Clinical Research Site Challenges Survey Report. based clinical research sites.

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Clinical Research Research Clinical Trials Clinical Trials 52

Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

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Clinical Trials Clinical Trials Trials Licensing 52

CTTI (Clinical Trials Transformation Initiative)

JANUARY 10, 2024

Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov allows access to current research and evidence for all partners in the clinical trials enterprise, including patients, providers, sponsors and investigators, regulators, payers, and health system leaders.

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Clinical Trials Clinical Trials Trials Compliance 65

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 71

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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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 178

Drug Discovery World

OCTOBER 27, 2023

Organ-chips combine cell culture with microfluidics to emulate the biological forces of different organ tissues and/or disease states, allowing pharmaceutical researchers to determine a drug candidates’ efficacy and toxicity ahead of clinical trials. Could organ-chips replace other research methods? Not yet, according to Ewart.

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Research Gene Therapy In-Vivo In-Vitro 72

Pharmaceutical Technology

MAY 11, 2023

The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later. In the study, 16 patients were treated with a vaccine called autogene cevumeran that contained a maximum of 20 neoantigens, alongside Roche’s anti-PD-L1 immunotherapy Tecentriq (atezolizumab).

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RNA Vaccination Vaccine Trials 345

Drug Discovery World

JANUARY 11, 2024

Researchers have used messenger RNA (mRNA) to create an effective therapy for a rare liver disease in preclinical studies, demonstrating the technology’s potential therapeutic use in people. mRNA contains instructions that direct the cells to make proteins.

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Research Gene Therapy RNA Gene 59

Medical Xpress

MARCH 20, 2023

Cancer treatment routinely involves taking out lymph nodes near the tumor in case they contain metastatic cancer cells. But new findings from a clinical trial by researchers at UC San Francisco and Gladstone Institutes shows that immunotherapy can activate tumor-fighting T cells in nearby lymph nodes.

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Clinical Trials Clinical Trials Containment Trials 98

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 124

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 134

Cloudbyz

SEPTEMBER 16, 2023

Addressing data privacy and data protection concerns when implementing ChatGPT in clinical trial operations management is crucial to maintain compliance with regulations, safeguard sensitive patient information, and build trust among stakeholders.

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Clinical Trials Clinical Trials Trials Compliance 59

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 104

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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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

Cloudbyz

APRIL 9, 2023

Clinical trial management involves various activities and processes that can have a significant impact on the environment and contribute to sustainability issues. Clinical trials, in particular, have a significant impact on the environment, and it is essential to address this impact to ensure a sustainable future.

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Clinical Trials Clinical Trials Trials Biohazard 52

XTalks

JULY 18, 2023

Billion in Talc Lawsuits But Not Enough Says a Plaintiff Group Although Johnson & Johnson maintains its talc products do not contain asbestos and are safe, the company has taken its baby powder off shelves in the US and Canada and plans to do the same globally this year. Related: Johnson & Johnson Offers $8.9

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Research Contamination Doctors Doctor 95

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

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 180

Trialfacts

JANUARY 23, 2024

While there is no cure for a peanut allergy, researchers are exploring ways to make the impact of this allergic reaction less severe. Researchers are exploring the potential effects of a new medication because they understand that a peanut allergy is not only dangerous, but it can impact a child’s emotional and mental health as well.

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Allergies Research Doctors Doctor 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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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

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

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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Vaccination Vaccine Manufacturing Containment 279

Trialfacts

MARCH 1, 2023

Researchers and Actinogen Medical are currently exploring a new potential treatment, Xanamem®, for those with depressive symptoms who are also experiencing cognitive symptoms. If you have been diagnosed with depression and would like to contribute to the development of a potential new treatment, then consider joining this research study!

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Research Clinical Trials Clinical Trials Containment 52

Drug Discovery World

OCTOBER 9, 2023

Positive Phase I trial data indicates that Reqorsa (quaratusugene ozeplasmid) has shown early efficacy for the treatment of non-small cell lung cancer (NSCLC). The data will be presented at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

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Gene Therapy Gene Clinical Trials Clinical Trials 110

WCG Clinical

JULY 12, 2023

Princeton, NJ, July 12, 2023 – WCG, one of the world’s leading providers of solutions that measurably improve the quality and efficiency of clinical research, released its 2023 Avoca State of the Industry Report. About Avoca Avoca, a WCG company, has been dedicated to improving quality and compliance in the clinical trial execution process.

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Clinical Research Research Clinical Trials Clinical Trials 52

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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