Clinical Trials, Containment and Trials - Clinical Research Informer

Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective

Pharmaceutical Technology

MAY 24, 2023

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

Clinical Trials

Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain

Phesi’s AI-driven Trial Accelerator platform contains over 100 million patients

Pharma Times

FEBRUARY 12, 2024

The platform delivers digitalised patient data to improve clinical trials and development

Containment

Containment Trials Clinical Trials Clinical Trials

Optimizing Patient-Driven Site Engagement in Rare Disease Clinical Trials

Worldwide Clinical Trials

AUGUST 29, 2024

By: Nathan Chadwick, Therapeutic Strategy Lead, Rare Disease Over the last few years in clinical trials, particularly within the rare disease community, a notable shift is underway, where patients and caregivers are taking the lead in reaching out to clinical trial sites rather than the other way around.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

EMA sets out proposals to reform EU’s clinical trials framework

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Health ministry releases 9th edition of IP containing 3,152 monographs

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 7, 2022

With an aim to improve the quality of drugs sold in the country, the Union health and family welfare ministry has released 9th edition of Indian Pharmacopoeia (IP) 2022 containing 92 new monographs for drugs, 12 new general chapters, 1,245 monographs for formulations, 930 monographs for active pharmaceutical ingredients (APIs) as well as dissolution (..)

Containment

Containment Drugs Clinical Trials Clinical Trials

March 23, 2023: AJOB Calls for Peer Commentaries on Ethics in Pragmatic Trials

Rethinking Clinical Trials

MARCH 23, 2023

The American Journal of Bioethics ( AJOB ) this week issued a call for peer commentaries for a forthcoming special issue on pragmatic clinical trials. Both of the target articles for the special issue are from the NIH Pragmatic Trials Collaboratory’s Ethics & Regulatory Core.

Trials

Trials Clinical Trials Clinical Trials Research

FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.

Gene Therapy

Gene Therapy Gene Trials Clinical Trials

Flow cytometry: advantages in immunotherapy clinical trials

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

Patient-Centered Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials Workshop: SCT (May 2024)

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

Clinical Trials Clinical Trials Trials Research

Predicting and improving clinical trial enrolment: A problem for psychiatry

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Clinical Trials for Celiac Disease: Insights from Beyond Celiac’s Kate Avery

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Immune Response

October 2, 2023: Patient-Centered Outcomes Core Develops Tool Kit to Promote Health Equity in PROs

Rethinking Clinical Trials

OCTOBER 2, 2023

The tool kit is intended for research teams conducting pragmatic clinical trials, including those participating in the NIH Pragmatic Trials Collaboratory’s Demonstration Projects. For more information, see the Patient-Reported Outcomes chapter of the Living Textbook.

Development

Development Nurses Clinical Trials Clinical Trials

The Future is Now: Trends in Clinical Trials Brought to Reality

Crucial Data Soutions

DECEMBER 15, 2020

A medical device sponsor is conducting a clinical trial on an innovative cardiac stent. The sponsor has chosen to take a hybrid approach to their study to decrease risk and increase patient safety, adhering to the FDA’s guidance on conducting clinical trials during the pandemic.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Clinical Trial Data Archiving: Ensuring Efficiency, Compliance, and Accessibility

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. Effectively managing and storing such large datasets presents logistical challenges.

Clinical Trials

Clinical Trials Clinical Trials Compliance Trials

How to achieve efficiency with a unified clinical trial management platform

Cloudbyz

FEBRUARY 23, 2023

Clinical trials are complex and resource-intensive endeavors, and as such, there is an increasing need to streamline clinical trial operations and increase operational efficiency. CTMS helps to streamline clinical trial processes, from study planning to site selection, enrollment, monitoring, and data analysis.

Clinical Trials

Clinical Trials Clinical Trials Trials Compliance

Scientists Finally Identified Where Gluten Reactions Begin

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 1, 2024

(uzhursky/Getty Images) For roughly one in every hundred people, food containing even the smallest amounts of gluten can deliver a gutful of hurt.

Scientist

Scientist Containment Genetics Clinical Trials

Eerie Personality Changes Sometimes Happen After Organ Transplants

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 21, 2024

The idea that the heart contains the very ‘essence’ of a person might be more than just a spiritual concept. Ever since the first human heart transplants back in 1967, patients have reported, often reluctantly, some eerie and inexplicable changes to their personalities.

Containment

Containment Clinical Trials Clinical Trials Clinical Research

Disease X: WHO Warns Future Outbreak Just a Matter of Time

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.

Containment

Containment Vaccination Vaccine Clinical Trials

FDA’s treatment of China-developed drugs spurs demands for multiregional clinical trials

pharmaphorum

JUNE 14, 2022

Despite more treatment options being a positive, Ben Hargreaves finds that this has raised issues over single-region clinical trials, leading to the FDA rejecting certain treatments and clarifying what is required for approval. Emphasising multiregional trials. Single-region concerns.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

Higher CO2 Levels Have a Concerning Effect on Viruses Floating Through The Air

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 9, 2024

Virus containing droplets were suspended in the CELEBS experimental device for different durations before infectivity was tested. Allen Haddrell/University of Bristol) Keeping CO2 levels low reduces infectious airborne viral loads, new research suggests.

Containment

Containment Research Clinical Trials Clinical Trials

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

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.

Clinical Trials

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New Anti-Hangover Pill Claims to Rapidly Break Down Alcohol, But Does It Work?

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.

Containment

Containment Sales Marketing Clinical Trials

Clinical Trial Kitting: Avoid Costly Pitfalls

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. On the surface, putting the kits together might seem simple enough, but it’s not.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Dr. Bahassi: There are several factors to consider when designing a trial that involves ctDNA detection.

Clinical Trials

Clinical Trials Clinical Trials Trials FDA Approval

The US Just Approved The First Over-The-Counter Daily Birth Control Pill

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 […]

Hormones

Hormones Containment Branding Drugs

Special Nasal Drops Could Help The Brain Recover After A Stroke

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 22, 2023

Scientists have demonstrated how nasal drops containing a particular molecule can help mice recover from the damaging biological consequences of a stroke – and the hope is that the treatment could eventually be transferred to humans. link] Crucially, the treatment isn’t applied straight away but is initiated seven days after the stroke.

Containment

Containment Scientist Clinical Trials Clinical Trials

Deadly ‘Zombie Drug’ Believed to Contain Human Bones Wreaks Havoc in West Africa

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 […]

Containment

Containment Drugs Clinical Trials Clinical Trials

Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

FDA Law Blog

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

Clinical Trials

Clinical Trials Clinical Trials Trials Regulation

UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

Pharmaceutical Technology

AUGUST 15, 2022

The updated, Omicron-containing bivalent vaccine that acts on two coronavirus variants is indicated as a booster dose for active immunisation for the prevention of Covid-19 in people of this age group. The latest MHRA decision is based on findings from the Phase II/III clinical trial, where the mRNA-1273.214 vaccine met all primary endpoints.

Vaccination

Vaccination Vaccine Immune Response Clinical Trials

Orange Peels Could Have Surprising Health Benefits For Your Heart

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 […]

Containment

Containment Clinical Trials Clinical Trials Clinical Research

Interview About Decentralized Oncology Trials with Devon Adams, Senior Analyst at the ACS CAN

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.

Trials

Trials Clinical Trials Clinical Trials Development

Grand Rounds September 8, 2023: The DEVICE Trial: An Embedded, Pragmatic Trial of Emergency Airway Management (Matthew Prekker, MD, MPH; Jonathan Casey, MD, MSc)

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?

Trials

Trials Clinical Trials Clinical Trials Medicine

Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

Clinical Trials

Clinical Trials Clinical Trials Vaccination Vaccine

The Promise of Clinical Trials in Advancing Solid Tumour Cancer Treatments

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Containment

CTTI and FDA Share Strategies for Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information for Applicable Clinical Trials on ClinicalTrials.gov

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Compliance

Kite and Arcellx enter partnership for multiple myeloma therapy development

Pharmaceutical Technology

DECEMBER 12, 2022

An investigational late-stage product candidate, CART-ddBCMA is being analysed in the Phase II iMMagine-1 clinical trial at present. It leverages the new D-Domain binder of Arcellx and contains autologous T cells genetically modified for targeting multiple myeloma.

Development

Development Gene Therapy Clinical Trials Clinical Trials

TN DCA soon to introduce action plan on AMR

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.

Containment

Containment Drugs Clinical Trials Clinical Trials

ICMR invites EoI for commercialization of RT PCR assay for detection of Influenza A, B, SARS CoV2

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 25, 2023

The EoI document containing the details of qualification […]

Containment

Containment Marketing Research Clinical Trials

Trial of Jazz’ cannabis drug in glioblastoma will start next year

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.

Trials

Trials Drugs Clinical Trials Clinical Trials

Experts advocate for immunizing both boys & girls against HPV with increasing incidences of cancer cases in India

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 2, 2023

The 9-valent HPV vaccine—Gardasil-9—helps in reducing the disease burden and cancers caused by the HPV types contained in […] Gardasil-9 is India’s first gender-neutral HPV vaccine.

Containment

Containment Vaccination Vaccine Clinical Trials

MDC recommends prices of anti-diabetic drugs with off patented molecules

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 12, 2023

The Multidisciplinary Committee (MDC) of Experts has recommended the prices of various fixed dose combinations (FDCs) containing dapagliflozin, sitagliptin, vildagliptin, pioglitazone, among others in tune with the recent amendments made by the Department of Pharmaceuticals (DoP) in the Drugs (Prices Control) Order (DPCO), 2013 related to fixing prices (..)

Drugs

Drugs Containment Clinical Trials Clinical Trials

The ABCs of Transitioning PK Assays from Preclinical to Clinical

Worldwide Clinical Trials

SEPTEMBER 29, 2022

Ensuring a seamless transition from preclinical to clinical stages in large molecule bioanalysis will help you reach crucial trial milestones on time and within budget. However, optimizing pharmacokinetics (PK) assays to bridge the preclinical-to-clinical gap requires some finesse. anti-human IgG).

Reagent

Reagent Clinical Trials Clinical Trials Antibody

Regulatory Strategy Considerations for Working with the FDA vs the EMA, Part 2

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.

Clinical Trials

Clinical Trials Clinical Trials Medicine Trials

Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective

Phesi’s AI-driven Trial Accelerator platform contains over 100 million patients

Trending Sources

Optimizing Patient-Driven Site Engagement in Rare Disease Clinical Trials

EMA sets out proposals to reform EU’s clinical trials framework

Health ministry releases 9th edition of IP containing 3,152 monographs

March 23, 2023: AJOB Calls for Peer Commentaries on Ethics in Pragmatic Trials

FDA suggests ways to curb constraints with rare disease gene therapy trials

Flow cytometry: advantages in immunotherapy clinical trials

Patient-Centered Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials Workshop: SCT (May 2024)

Predicting and improving clinical trial enrolment: A problem for psychiatry

Clinical Trials for Celiac Disease: Insights from Beyond Celiac’s Kate Avery

October 2, 2023: Patient-Centered Outcomes Core Develops Tool Kit to Promote Health Equity in PROs

The Future is Now: Trends in Clinical Trials Brought to Reality

Clinical Trial Data Archiving: Ensuring Efficiency, Compliance, and Accessibility

How to achieve efficiency with a unified clinical trial management platform

Scientists Finally Identified Where Gluten Reactions Begin

Eerie Personality Changes Sometimes Happen After Organ Transplants

Disease X: WHO Warns Future Outbreak Just a Matter of Time

FDA’s treatment of China-developed drugs spurs demands for multiregional clinical trials

Higher CO2 Levels Have a Concerning Effect on Viruses Floating Through The Air

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

New Anti-Hangover Pill Claims to Rapidly Break Down Alcohol, But Does It Work?

Clinical Trial Kitting: Avoid Costly Pitfalls

The Utility of Liquid Biopsy in Oncology Clinical Trials

The US Just Approved The First Over-The-Counter Daily Birth Control Pill

Special Nasal Drops Could Help The Brain Recover After A Stroke

Deadly ‘Zombie Drug’ Believed to Contain Human Bones Wreaks Havoc in West Africa

Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

Orange Peels Could Have Surprising Health Benefits For Your Heart

Interview About Decentralized Oncology Trials with Devon Adams, Senior Analyst at the ACS CAN

Grand Rounds September 8, 2023: The DEVICE Trial: An Embedded, Pragmatic Trial of Emergency Airway Management (Matthew Prekker, MD, MPH; Jonathan Casey, MD, MSc)

Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

The Promise of Clinical Trials in Advancing Solid Tumour Cancer Treatments

CTTI and FDA Share Strategies for Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information for Applicable Clinical Trials on ClinicalTrials.gov

Kite and Arcellx enter partnership for multiple myeloma therapy development

TN DCA soon to introduce action plan on AMR

ICMR invites EoI for commercialization of RT PCR assay for detection of Influenza A, B, SARS CoV2

Trial of Jazz’ cannabis drug in glioblastoma will start next year

Experts advocate for immunizing both boys & girls against HPV with increasing incidences of cancer cases in India

MDC recommends prices of anti-diabetic drugs with off patented molecules

The ABCs of Transitioning PK Assays from Preclinical to Clinical

Regulatory Strategy Considerations for Working with the FDA vs the EMA, Part 2

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