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A new clinical trial of five children with inherited deafness found administering gene therapy in both ears led to restored hearing and speech, and additional gains including sound source localization, ability to hear in noisy environments, and for two children, abillity to appreciate music.
Adults with hemophilia B saw their number of bleeding episodes drop by an average of 71 percent after a single infusion of gene therapy, according to the new results of an international Phase III clinical trial.
The company claimed “higher than anticipated” scores from trial volunteers on placebo led to the disappointing data, prompting it to halt internaltrials.
An international team has shown that the injection of a type of stem cell into the brains of patients living with progressive multiple sclerosis (MS) is safe, well tolerated and has a long-lasting effect that appears to protect the brain from further damage.
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. local standards of care).
FSP solutions are widely used in biotech Biotech companies of any size can benefit from using a contract research organization (CRO) to fulfill trial-related functions and services. With FSO, all tasks for a clinical trial are outsourced. are outsourced.
2] History The efficacy and safety of fitusiran were assessed in two multicenter, randomized clinical trials which enrolled a total of 177 adult and pediatric male participants with either hemophilia A or hemophilia B. [2] 2] [3] Names Fitusiran is the international nonproprietary name. [4] Fitusiran 1711.0g/mol, Fitusiran 1711.0g/mol,
“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.
By partnering with a contract research organization (CRO) that understands the challenges of liver disease clinical trials — and the complexities of working with pediatric populations — you can drive your treatment forward. Partnership with an experienced CRO is essential to your trial’s success. Hispanic: 11.8%
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.
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.
Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.
Cost and complexity go hand-in-hand The rising costs and growing complexity in clinical trials are deeply linked, with patient recruitment, extended timelines and meeting regulatory demands emerging as some of the key drivers. Nearly half (49%) of clinical trial sponsors surveyed identified rising costs as their foremost concern in 2024.
From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape. Drug development The rising cost of clinical trials is the top challenge this year, due to increasingly complex protocol designs and difficult patient recruitment.
Types of Drug Applications The PMDA accepts three main types of drug applications: Investigational New Drug (IND) : Required for conducting clinical trials in Japan. Challenges and Opportunities Ethnic Bridging : Japan has historically required clinical trials to be conducted within the country to account for ethnic differences.
Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.
A team of surgeons and scientists from the UK, Sweden and Canada, funded by Rinri Therapeutics, has confirmed secure surgical access to the central core of the human cochlea The research, published in Scientific Reports, is critical to the first in-human trials of new cell, gene and drug therapies for the inner ear, and will assist with treatment for (..)
Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.
On the International Day of Persons with Disabilities , it is important to make sure that we think about ALL people with disabilities. The trial We are recruiting 66 educational settings and will involve 330 children and young people and their families. We will conduct the study at educational settings throughout the country.
In just two years, CTMC has advanced eight therapies into clinical trials, harnessing genetic engineering to enhance T-cell effectiveness in the fight against cancer. Bock explained that the supply chain for clinical trials typically follows a linear model for traditional therapies, where manufacturing is separate from the clinic.
Creating clinical trial marketing materials is a delicate balance — it's important to craft outreach that connects with patients and care partners, but it’s also important to adhere to the guidelines set out by the Food and Drug Administration (FDA) to receive the approval of the Internal Review Board (IRB).
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.
Leveraging Data for More Inclusive Research Clinical trial representation is more than just a regulatory requirementits a critical component of accessible healthcare. Ensuring that trial participants reflect the real-world patient population leads to more effective treatments and better health outcomes.
Now take a step further: envision testing drugs in these organoids to identify the ones that can treat disease safely and effectively without needing to run expensive clinical trials first. Further still, think about implanting these mini organs into the patient to restore lost function. Cell Stem Cell. 2013;13(6):734-44.
This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. Additionally, consider the locations of your trial; if it is multiregional, you can start planning for your overall product approval strategy.
Yet, what about those who took part in the trial? In recent years there has been an increasing call to let trial participants know the results of trials in which they have taken part. Back in 1995 only one person in every 27 was on a trial in cancer. The post Clinical Trials Day 2023: what about the trial participant?
For more than 35 years, Advarra has been committed to protecting the rights and welfare of clinical trial participants while helping to improve healthcare outcomes, advancing medical knowledge, and bringing innovative, life-extending treatments to market that benefit millions of patients worldwide.
PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. What are PROs in clinical trials? In a study on cancer clinical trials, Pe et al. In a study on cancer clinical trials, Pe et al.
Advancing reduction of drug use as an endpoint in addiction treatment trials astewart Thu, 03/06/2025 - 09:59 Nora's Blog March 18, 2025 Image Getty Images/ SolStock This blog was also published in the American Society of Addiction Medicine (ASAM) Weekly on March 18, 2025.&
Internships at Altasciences: Q&A With Our Summer Interns nbartlett Thu, 08/22/2024 - 04:44 Internships at Altasciences are more than just a stepping stone—they’re a gateway to real-world-experience and professional growth, giving the next generation opportunities to help shape progress in the drug development industry. The work environment.
The success of clinical trials hinges on increasing access to participation by all eligible patients, including populations that have been underrepresented due to the barriers highlighted below. Representation, Underrepresentation & Diversity in Clinical Trials Studies indicate a need to increase patient accessibility to clinical trials.
This blog explores what it takes for an EAC/CEC to adequately support worldwide clinical trials. Having one set of adjudicators across the entire trial aids consistency of determinations and allows for a central decision-making framework. The Global Reach of EACs and CECs. Source: United Nations Conference on Trade and Development.
By employing advanced analytical techniques like high-resolution mass spectrometry (HRMS) and carefully calibrating systems with optimal internal standards (IS), we effectively mitigate matrix effects and provide reliable preclinical toxicology data. These solutions must contain analytes and internal standards at known concentrations.
This data will be presented as a late-breaker ePoster during the International Headache Society (IHS) and European Headache Federation (EHF) Joint Congress taking place virtually on Sept. Adverse Reactions: The most common adverse reactions in clinical trials (?5% 8-12, 2021. Reactions have included anaphylaxis and angioedema.
Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Effective budget management not only ensures trials are financially viable but also maximizes return on investment (ROI). the impact and value of the data produced).
Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. As clinical trial design becomes more dynamic and adaptive, studies require more complex statistics and more specialized biostatisticians to ensure study data are relevant and scientifically valid.
Food and Drug Administration (FDA) issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics , regarding clinical trial design specific to oncology with considerations to support accelerated approval applications.
Clinical trials assessing the impact of Radiotherapy (RT) in combination with inhibitors of the DNA Damage Response Pathway (DDRi) and/or immune checkpoint blockade are currently ongoing. Nonlinear mixed effects modelling was performed followed by internal validation with Visual Predictive Checks (VPC).
Results from an international clinical trial, published June 15 […] Credit: Vanderbilt University Medical Center A new therapy is on the horizon for patients with metastatic colorectal cancer who have run out of treatment options.
Clinical trial performance knowledge on physicians and research sites is one of these elements. H1 is pioneering in the area of clinical trial performance data integration and use and regularly advises customers in 3 key areas. What Is Performance Data and How Do You Benchmark It? How Can Performance Data Make a Difference?
The favourable tolerability of eliapixant in this trial is consistent with earlier clinical findings. The selective mechanism of action of eliapixant appears to be translating into improved tolerability in clinical trials. Most were described as “a little” and “somewhat” bothersome, none described as “extremely” bothersome.
Introduction Worldwide Clinical Trials vs. Vial. Worldwide Clinical Trials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. With an international presence in nearly 60 countries, Worldwide is supported by over 3,400 team members.
Genetic testing provides patients with a diagnosis for their illness, helps patients and family members to understand risks of developing new diseases, and can be used to support clinical trial advancement. Can prior genetic testing results be utilized in a trial, or should a new genetic sample be taken before participating?
Sponsors: The trial sponsor is primarily responsible for many study startup activities including but not limited to : . Engaging a CRO to assist in the execution of the trial . Collecting, storing, and submitting the data and documents associated with the trial . Conducting clinical trial visits and procedures .
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