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)?

Clinical Trials 100

Clinical Trials Clinical Trials Trials Research 100

Advarra

DECEMBER 17, 2024

2024 has been a year of growth and evolution in clinical research. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.

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Clinical Research Research Trials Clinical Trials 98

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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Containment Sales Marketing Clinical Trials 246

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 242

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 189

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 180

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 189

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

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 181

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

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

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

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

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

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

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

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

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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Vaccination Vaccine FDA Approval Trials 147

Pharmaceutical Technology

APRIL 12, 2023

Xenetic Biosciences (Xenetic) and the Scripps Research Institute (TSRI) have entered into a research funding and option agreement for advancing the former’s DNase platform. NETs are weblike structures that contain extracellular chromatin coated with histones and other proteins.

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Research Development Containment Protein 130

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

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

XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. percent and 22.5 percent, respectively, compared to placebo.

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Trials Drugs FDA Approval Clinical Trials 98

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

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

World of DTC Marketing

MAY 24, 2022

In another study of apps for anxiety, scientists found that out of the 25 highest-rated apps for fear, exactly zero contained any content consistent with evidence-based treatments. While this sounds unfortunate, this may be related to the study methods in which researchers grouped interventions that may be completely different.

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Licensing Licensing Scientist Production 252

XTalks

OCTOBER 29, 2024

Protocols drive every clinical study, guiding research teams from early inception through planning and into the trial’s execution. Clinical trial protocols are also very complex, with detailed schedules of assessments, inclusion/exclusion criteria and scientific reasoning all captured into a single written document.

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Clinical Research Research Clinical Trials Clinical Trials 59

Camargo

SEPTEMBER 14, 2021

An IND submission serves as a request to start clinical studies, containing a summary of information known about the drug, including nonclinical studies; chemistry, manufacturing and controls (CMC); and a proposed clinical plan. INDs must contain full study reports of nonclinical and clinical (if available) studies.

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Clinical Trials Clinical Trials Medicine Production 144

Pharmaceutical Technology

APRIL 4, 2023

The combination therapy can be used to treat la/mUC patients who do not qualify for cisplatin-containing chemotherapy. It is supported by objective response rates (ORR) and median duration of response (DOR) in combined dose escalation/cohort A and cohort K of the Phase lb/ll KEYNOTE-869 study, also known as the EV-103 trial.

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Antibody Containment Clinical Development Trials 130

WCG Clinical

OCTOBER 8, 2024

Princeton, NJ – October 8, 2024 – WCG, the global leader in providing solutions that measurably improve the quality and efficiency of clinical research, today released the WCG 2024 Clinical Research Site Challenges Report. As a result, many sites are struggling to keep pace with the demands of modern clinical research.

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Clinical Research Research Clinical Trials Clinical Trials 59

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

Pharmaceutical Technology

OCTOBER 26, 2022

Early gene therapy methods were proposed in the 1970s, and the first approved gene therapy clinical research in the US began in 1990. Research is showing particular promise in areas such as lymphoma, leukaemia, and haemophilia. Gene and cell therapies are revolutionising the way healthcare is delivered.

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Gene Therapy Gene Marketing Manufacturing 130

Delveinsight

JULY 27, 2021

Various Active Pharmaceuticals & Biotechnological Companies including Cassava Sciences, INmune Bio, Cognito Therapeutics, Cortexyme among others presented their new and upcoming drugs, therapies, shared their research studies and clinical data. P-tau 181 plasma levels were also reduced in a good amount. INmune Bio Inc. , gingivalis.

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Vaccination Vaccine Trials Manufacturing 96

XTalks

FEBRUARY 4, 2021

Generation of strong research dataset cohorts must begin with high-quality clinical samples. Moreover, biobanks are no longer passive biorepositories for accrual of samples and serve a more utilitarian function in identifying and coordinating specific research cohorts for longitudinal and prospective studies.

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Research Biobanking Drugs Genome 98