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Clinical Trial Design Articles & Analysis
19 articles found
The Evolution of Antibody Drug Design Traditional methods of drug development often involved trial-and-error approaches to identify suitable candidates. ...
By modeling and simulating these interactions, scientists can predict the behavior of a drug across various populations and dosing scenarios. This aids in designing clinical trials, personalizing medicine, and improving drug safety profiles. ...
Clinical trials are the backbone of modern medicine, responsible for bringing innovative, safe, and efficient treatments to market after rigorous testing and evaluation. However, the conventional process of conducting these trials has often been long, expensive, and fraught with inefficiencies¹. The advent of predictive analytics is ...
Medical advancement relies on clinical trials, which are essential for the development of safe and effective innovative treatments. However, the success and general applicability of these treatments heavily depend on the diversity of the participants involved¹?³. This blog explores the importance of achieving data diversity in clinical trials to enhance clinical trial results and ...
Dr. Kate Sasser from Tempus led a discussion on the potential of antibody-drug conjugates (ADCs), their challenges in targeting tumor antigens, and the future of cancer treatment with Dr. Daniel Johnson, Dr. Funda Meric-Bernstam, and Dr. Kellogg Parsons. The oncology field is rapidly advancing with the development of antibody-drug conjugates (ADCs), offering new hope for ...
ByTempus
In addition, many CDM systems are not user-friendly or interactive, making it difficult for users to get the most out of them. What challenges do clinical data management systems currently face? Clinical Trial Complexity The modern clinical trial design requires real-time data modelling and ...
ByClinion
Animal models play a critical role in biomedical research, as they allow scientists to study complex disease processes, develop new therapies, and test their safety and efficacy before moving into human clinical trials. To date, several excellent models have already been developed, such as the GAA-knockout mouse model for Pompe’s disease and the Sgca-null ...
Challenge Calculating the appropriate sample size for a first of its kind stage-II colon cancer trial As Chairman of the Department of Biostatistics, Professor Satoshi Teramukai leads a variety of investigator-initiated clinical trials at the Kyoto Prefectural University of Medicine. With over 35 years experience, hundreds of published papers ...
ByStatsol
Luis Rojas, the Executive Director Head of Biostatistics at Target Health, is a subject matter expert in study design and sample size calculations with more than 30 years of industry experience. He has worked in the leading CROs in the industry and has assisted pharmaceutical companies with the drug development process with clinical trials, ...
ByStatsol
We also discuss challenges posed in clinical trial design for these novel device–based strategies including optimal patient selection and appropriate end points to establish efficacy. ...
Study to be conducted at two leading research institutions in the U.K. Results will inform protocol design of Phase 1/2 clinical trial of Company's lead HSV-2 therapeutic vaccine candidate WOBURN, Mass. and OXFORD, England, Aug. 15, 2022 /PRNewswire/ -- Rational Vaccines, a company focused on revolutionizing the treatment and prevention of ...
Clinical trials are often designed with the participant’s everyday life in mind – trying to gather as much clinically-relevant data in a controlled manner as possible while allowing individuals to live their regular lives. ...
ByAiCure
Revisiting the “why” behind decision making can be a helpful exercise in all aspects of business. This is no less true for clinical operations executives when it comes to the clinical trial systems they employ to facilitate their teams’ work. The technology that supports clinical trial systems has evolved steadily over the past several decades, yet the ultimate goal of ...
RVx201 is the first vaccine for HSV-2 to be awarded this designation under ILAP, which the MHRA launched in January 2021. On August 15, 2022, Rational Vaccines confirmed the observational clinical study, "A Study of the Characteristics of Patients Diagnosed With Recurrent Symptomatic Genital Herpetic Disease," with about 200 participants will be conducted at ...
The COVID-19 pandemic has catalyzed the implementation of decentralized clinical trials in neurology, bringing the immense benefits of clinical trials to light. This industry-wide push towards trial decentralization has emerged as a key element for improving clinical trial efficiency and improving the experience for patients and physicians. By utilizing digital technologies, such as wearables, ...
“We are thrilled with the study team assembled for this clinical trial, from our contract research organization to our clinical investigators, and look forward to topline proof of concept data by the first quarter of 2023.” About A197-CS-201 The phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel-group ...
These findings paved the way for prospective clinical trials designed to test whether incorporating this biomarker into patient care can improve the prognosis of patients who are unlikely to benefit from existing therapies. ...
Abstract Phase I clinical trials are the first step in drug development to test a new drug or drug combination on humans. Typical designs of Phase I trials use toxicity as the primary endpoint and aim to find the maximum tolerable dosage. ...
The toothpaste, called Allerdent, which Dr. Reisacher is testing in clinical trials, is designed to seamlessly integrate into patients' everyday routines, boosting their immunity to the very airborne substances that cause allergy sufferers to sneeze, cough, wheeze, drip and tear. ...