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
The trial was stopped early by the recommendation of the Data Monitoring Committee due to an overwhelming reduction in bleeding compared to standard-of-care treatment.
However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.
Serious adverse events (SAEs) are among the most critical data points collected during a clinical trial. The post How EDC-Based SAE Reporting Reduces Time to Detection and Response in Clinical Trials appeared first on Crucial Data Solutions. The timeliness and accuracy.
The day inspires multiple events, such as fundraisers and scientific symposia, to bring together all the critical stakeholders who tirelessly work to make life better for those affected by rare diseases. In an incredible feat of collaboration, they were able to rapidly put together a new event called Rally for Rare.
Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management.
Clinical trials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinical trials requires efficient communication and coordination among various stakeholders. This is where contact center services play a vital role.
In an era where clinical trials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinical trial’s safety and efficacy.
A surrogate endpoint is a marker used in clinical trials as a substitute for a direct clinical outcome. Diagnostic biomarkers typically confirm or establish a diagnosis and are often used in selecting patient populations for clinical trials.
The Week 26 data from the COACH Trial now show that TransCon hGH may further enhance these benefits. COACH Trial Overview The COACH Trial is a prospective, Phase 2, open-label, proof-of-concept study designed to evaluate the efficacy, safety, and tolerability of the combination therapy. mg/kg/week) during the trial.
In the realm of vaccine development, mega trials — studies enrolling 5,000 subjects or more — have been instrumental in the fight against many pathogens, including influenza, rotavirus, malaria, RSV and most recently in the rapid development of vaccines against COVID-19.
has announced encouraging interim findings from the pivotal Phase 3 VISIONARY trial evaluating sibeprenlimab in adults with Immunoglobulin A nephropathy (IgAN), a rare and progressive autoimmune kidney disorder. Treatment-emergent adverse events (TEAEs) occurred in 76.3% in collaboration with Otsuka Pharmaceutical Co.,
Each November is designated as Diabetes Awareness Month , an event that highlights the importance of spreading awareness about diabetes and the health issues it can cause.
“Patient-centric” is used frequently to describe today’s clinical trial and health care landscape. The industry applauds that point of view and strives to include a patient-centric approach in all aspects of clinical trial designs. Patient centricity has become more than a key consideration.
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.
Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success. Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success.
Is That Heart Attack Really an Adverse Event? The success of your highly complex clinical trial depends on accurate, reliable assessments of your endpoints. Learn how to accurately identify and attribute adverse events, eliminate conflicts of interest, and ensure the integrity of your studies.
1] [2] Adverse effects The US Food and Drug Administration prescription label for fitusiran contains a boxed warning for thrombotic events (blood clotting) and gallbladder disease (with some recipients requiring gallbladder removal). [2] Fitusiran 1711.0g/mol, 1] It is an antithrombin-directed small interfering ribonucleic acid. [1]
Considering such findings, the United Nations Office on Drugs and Crime (UNODC) combined the TRT intervention with parenting strategies designed to enhance the carer’s capacity to support children through life events such as disasters, conflicts, and displacement. TRT + Parenting was trialled in Lebanon with Syrian families.
Yet, four out of five care partners of people with neurodegenerative disorders have never been informed of clinical trial opportunities , according to a survey of more than 250 caregivers conducted by PPD, the clinical research business of Thermo Fisher Scientific. There’s little time to lose.
For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. This is why oncology trials must be built around patient needs, and sponsors need to balance the complexity of oncology trials with a patient-centric mindset. Many of these patients’ conditions are disabling.
As a proof of concept, a drug designed to target a newly discovered biological node is showing efficacy in treating rare genetic diseases in the kidney, the eye, and the brain and is now making its way to clinical trials in collaboration with a pharmaceutical partner. We will keep you in the loop on upcoming events and research highlights.
Stay informed on essential regulations governing Nutraceutical Clinical Trials in India, with a detailed look at ethical standards, CDSCO oversight, and trial conduct protocols.
Herbal clinical trials in […] The post Essential Compliance Checklist for Regulations on Herbal Clinical Trials in USA appeared first on ProRelix Research. With the increasing popularity of herbal products for both preventive care and therapeutic intervention, the demand for rigorous scientific validation is stronger than ever.
Assessing and reporting adverse events (AEs) in clinical trials is critical to ensuring the study is as safe as possible and the participants have the most up to date information so they can decide whether to continue their participation in the research study. Who Should Assess AEs in Clinical Trials? regulations.
Todays clinical trials rely on technologically sophisticated systems that require complex integrations to capture and process all manner of data across multiple sites, often spread throughout multiple countries or jurisdictions. Electronic medical records (EMRs), for example, exemplify the evolving role of technology in clinical trials.
The Untitled Letter notes that the confirmatory trial for LYTGOBI is currently ongoing and has not been completed; therefore, clinical benefit of LYTGOBI has not yet been confirmed. As a single-arm trial (i.e., The Untitled Letter states that a randomized controlled trial would be needed to assess delay in time to disease progression.
The 7th World Conference on Targeting Phage Therapy 2024, two-day event dedicated to advancing the field of phage research and therapy will be hosted at Corinthia Palace Malta on June 20-21.
Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.
In this podcast interview, Dan Fisher, managing director and practice lead for IPM.ai, explains the use of artificial intelligence for stitching together key medical events that may happen over a r | IPM.ai helps brands assess a unique patient population, accelerate clinical trial recruitment, and optimize commercial outcomes
Safety Profile and Adverse Events Liso-cel displayed a consistent and manageable safety profile, with low rates of severe side effects and no new safety signals. Neurologic events (NE) of any grade were documented in 33% of patients, with Grade 3 NEs in 4% and no Grade 4 or 5 NEs. Importantly, there were no cases of Grade 4 or 5 CRS.
AI also has the potential to incorporate real-world data (RWD) obtained from electronic health records (EHRs), medical claims or other data sources to inform the design and optimization strategy of clinical trials. A high-risk participant can be even excluded from the study based on the severity of the adverse event.
Sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), the event was the largest psychedelics conference in history, bringing in approximately 12,000 participants and 300+ speakers from around the world. Check out our full psychedelics offering, and meet the team responsible for planning your clinical trial.
The landscape of clinical research is undergoing major changes with virtual clinical trials driving these transformations. These innovative trials promise to revolutionise the way medical research is conducted, making it more accessible, efficient, and patient-centric than ever before.
Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery. As clinical trials grow in complexity, the volume of data being gathered and utilized for these studies is expanding.
Learn more about chemical registration and the other benefits of CDD Vault and get your free trial. By registering new compounds, you make them available throughout CDD Vault for mining and analysis of screening results, for Structure Activity Relationship (SAR) studies, and for sharing with collaborators.
Director of Lymphoma Research at Sarah Cannon Research Institute and principal study investigator for the trial. Two cases of immune effector cell–associated neurotoxicity syndrome (ICANS) were observed — one Grade 1 and another Grade 3 , with the Grade 3 event occurring in a patient with central nervous system (CNS) lymphoma.
In case you missed it, we’re sharing some of our key takeaways from the four-day event, which focused on charting new horizons in clinical trials. Not only was it a lovely opportunity to connect with many industry professionals and learn from experts, but it was also the celebration of 60 years of DIA.
Hear about the new requirements under FDORA related to increasing diversity in clinical trials, strategies for increasing the participation of subjects from historically underrepresented groups, and how these new requirements and approaches should be considered in clinical trial and other related agreements.
The double-blind treatment period lasted 24 weeks, during which both efficacy and adverse events (AEs) were closely monitored. Primary Endpoint Met: Improved Tolerability with Atogepant At the core of the TEMPLE study was the investigation of treatment discontinuation rates due to adverse events, a key measure of real-world drug tolerability.
Clinical trials although methodically planned, can hit unexpected roadblocks steering them off course. From resource shortages and unforeseen service needs to contractual issues, recruitment problems and adverse events, these challenges can bring even the most carefully planned trials to a grinding halt.
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.
Dapirolizumab Pegol Demonstrates Promise in Phase 3 SLE Trial, Showing Improvements in Fatigue and Disease Activity at EULAR 2025 UCB (Euronext Brussels: UCB) and Biogen Inc. The latest data from the PHOENYCS GO trial reinforce the potential of dapirolizumab pegol to improve disease outcomes in people with moderate-to-severe SLE.
EVEREST is the first-ever trial to demonstrate the superiority of Dupixent over Xolair on both nasal polyp endpoints and related symptoms in patients with co-existing asthma, while retaining a generally similar safety profile. Serious adverse events were somewhat lower in Dupixent (2%) than in omalizumab (4%).
We organize all of the trending information in your field so you don't have to. Join 15,000+ 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