Clinical Trial Label Design Articles & Analysis: Older
18 articles found
Pharmacokinetics (PK) and pharmacodynamics (PD) are two fundamental pillars in the field of pharmacology and drug development. Understanding their intricate interplay is essential for determining the efficacy and safety of therapeutic compounds. When studied in living organisms, this relationship is referred to as in vivo PK/PD, a discipline that provides invaluable insights into drug behavior ...
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 reshaping the landscape of clinical trials, ushering in a ...
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
One of the biggest challenges clinical data management faces is the sheer amount of data that needs to be processed. With more and more patient data becoming available, it can be difficult for CDM systems to keep up. 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 ...
ByClinion
Rare diseases, also known as orphan diseases, are a diverse group of disorders that affect a small percentage of the population. Due to their low prevalence and limited understanding, treating and finding cures for these conditions present significant challenges. However, preclinical animal models have emerged as invaluable resources for advancing research and unraveling the mysteries surrounding ...
Effective and Efficient Drug Development Challenge Increased Cost, Risk, and Competition in the Drug Development Processes Dr. 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 ...
ByStatsol
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 and thousands of citations, Professor Satoshi ...
ByStatsol
Abstract Acute decompensated heart failure remains the most common cause of hospitalization in older adults, and studies of pharmacological therapies have yielded limited progress in improving outcomes for these patients. This has prompted the development of novel device–based interventions, classified mechanistically based on the way in which they intend to improve central hemodynamics, ...
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 herpes to eradicate the disease, today announced the ...
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. However, it is true that trials are artificial environments, and participants are actively monitored to ensure their safety and to determine the efficacy of a drug ...
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 Herpes Vaccine Description 2022 RVx201 is a first-in-human herpes simplex virus type 2 (HSV-2) live-attenuated therapeutic vaccine modified to be interferon sensitive that destroys the ability of the virus to inhibit immune responses. Produced by Rational Vaccines, Inc., the technology is based on the pioneering research of the late Dr. William Halford, who dedicated over 25 years to ...
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, ...
Aramis Biosciences announced that the first patient has been dosed in its phase 2 proof of concept clinical trial evaluating A197, a novel, first-in-class, topical immunomodulatory agent for the treatment of dry eye disease. “This is an important milestone for Aramis Biosciences and a hopeful moment for dry eye patients given the suboptimal efficacy and tolerability limitations commonly ...
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. However, these designs are poorly applicable for the development of cancer therapeutic vaccines because the expected safety concerns for these vaccines are not ...
Derek Lacarrubba was allergic to New York City. Lacarrubba, 31, got stuffed up around cats, dogs, three kinds of dust mites and several varieties of native New Yorkers - trees, that is. He couldn't sleep. He had trouble going to the gym. And as an attorney, he was too busy to commit to the years-long treatments doctors typically recommend: weekly shots at the doctor's office or holding liquid ...