This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
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 clinicaltrials holding great hope for the treatment of challenging and uncurable diseases.
Clinicaltrial 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 clinicaltrials. On the surface, putting the kits together might seem simple enough, but it’s not.
By: Nathan Chadwick, Therapeutic Strategy Lead, Rare Disease Over the last few years in clinicaltrials, particularly within the rare disease community, a notable shift is underway, where patients and caregivers are taking the lead in reaching out to clinicaltrial sites rather than the other way around.
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 (..)
The American Journal of Bioethics ( AJOB ) this week issued a call for peer commentaries for a forthcoming special issue on pragmatic clinicaltrials. Both of the target articles for the special issue are from the NIH Pragmatic Trials Collaboratory’s Ethics & Regulatory Core.
On February 7, at a town hall organised to discuss clinicaltrial 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.
Patients provide blood samples for clinicaltrial 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.
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)?
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 clinicaltrials.
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 clinicaltrials for celiac disease to investigate potential new treatments.
The tool kit is intended for research teams conducting pragmatic clinicaltrials, 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.
A medical device sponsor is conducting a clinicaltrial 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 clinicaltrials during the pandemic.
Clinicaltrials are crucial for advancing medical research and developing innovative treatments. Effective clinicaltrial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. Effectively managing and storing such large datasets presents logistical challenges.
Clinicaltrials are complex and resource-intensive endeavors, and as such, there is an increasing need to streamline clinicaltrial operations and increase operational efficiency. CTMS helps to streamline clinicaltrial processes, from study planning to site selection, enrollment, monitoring, and data analysis.
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.
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.
Despite more treatment options being a positive, Ben Hargreaves finds that this has raised issues over single-region clinicaltrials, leading to the FDA rejecting certain treatments and clarifying what is required for approval. Emphasising multiregional trials. Single-region concerns.
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.
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.
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 […]
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 ClinicalTrials.
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.
Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinicaltrials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinicaltrial. COVID-19 ClinicalTrials.
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 […]
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 clinicaltrial, where the mRNA-1273.214 vaccine met all primary endpoints.
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 […]
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.
Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in ClinicalTrials ” that revises the 2006 guidance “Establishment and Operation of ClinicalTrial Data Monitoring Committees” and, when final, will replace the 2006 guidance.
Xtalks interviewed Devon Adams to learn more about his work related to decentralized oncology trials as a senior analyst for legislative policy specific to clinicaltrials at the ACS CAN. Read on to learn more! Over 1,100 cancer patients and cancer survivors responded.
For example, AI tools can pull data from protocols and automatically update clinicaltrial management systems (CTMS), reducing manual entry errors and increasing workflow speed. This same data could be used to auto-generate study calendars based on the schedule of assessments, streamlining trial planning.
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?
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 clinicaltrial sites run by a third-party clinicaltrial site operator.
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 ClinicalTrials in Advancing Solid Tumour Cancer Treatments appeared first on ProRelix Research.
An investigational late-stage product candidate, CART-ddBCMA is being analysed in the Phase II iMMagine-1 clinicaltrial at present. It leverages the new D-Domain binder of Arcellx and contains autologous T cells genetically modified for targeting multiple myeloma.
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 (..)
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.
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.
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).
Clinicaltrials of a wireless brain chip developed by Elon Muck’s Neuralink company will be tested in human volunteers within the next six months – and Musk himself says he intends to have one implanted for a future demo event. The post Elon Musk’s Neuralink brain interface chip set for human trials appeared first on.
Timely, accurate, and complete registration and reporting of summary results information for applicable clinicaltrials on ClinicalTrials.gov allows access to current research and evidence for all partners in the clinicaltrials enterprise, including patients, providers, sponsors and investigators, regulators, payers, and health system leaders.
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).
We organize all of the trending information in your field so you don't have to. Join 21,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content