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Showing "Automation Elixir Bringing Speed Efficiency Clinical Trials Development" PubMed Articles 1–25 of 52,000+

Promotion of Japan's participation in global clinical trials.

The number of global clinical trials including Japan is increasing but still much lower than those including the USA and Europe. The regulatory requirements for clinical trials have been harmonized among Japan, USA, and Europe, and the quality of clinical trials is kept high in these regions. Xofluza (baloxavir marboxil) for influenza approved in Japan under the SAKIGAKE Designation System is a good example of clinical trials including Japan. To include Japan in more global clinical trials, stakeholders sho...

The role of the nurse in supporting cancer clinical trials.

Clinical trials are a fundamental component of high-quality care, and have been widely reported to improve care and patient outcomes. For research trials to be successful, patients need to have awareness of trials, be invited to participate, and be supported to make informed decisions about consenting to enrol in clinical trials. Some cancer nurses have been reported to be reluctant to discuss clinical trials with patients, based on their own beliefs about the perceived burden of clinical trials, while othe...

Current challenges in the development of new treatments for lupus.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a considerable impact on patients' quality of life. Despite the plethora of clinical trials for SLE since the turn of the millennium, only one new treatment has been approved for the condition, and the overall pace of successful drug development remains slow. Nevertheless, the myriad of clinical studies has yielded insights that have informed and refined our understanding of eligibility criteria, outcome measures and trial design in SLE...

Sex Bias in Interventional Clinical Trials.

Prior studies have shown that sex bias exists with subject enrollment in clinical trials, with more men being enrolled than women. The objective of this study was to identify if sex bias continues to exist in present day clinical trials entered into . We hypothesize that males and females are not equally represented in recent clinical trials.

Development and therapeutic potential of autotaxin small molecule inhibitors: From bench to advanced clinical trials.

Several years after its isolation from melanoma cells, an increasing body of experimental evidence has established the involvement of Autotaxin (ATX) in the pathogenesis of several diseases. ATX, an extracellular enzyme responsible for the hydrolysis of lysophosphatidylcholine (LPC) into the bioactive lipid lysophosphatidic acid (LPA), is overexpressed in a variety of human metastatic cancers and is strongly implicated in chronic inflammation and liver toxicity, fibrotic diseases, and thrombosis. Accordingl...

Use of Precision Medicine in Clinical Trials in Inflammatory Bowel Disease.

The conventional drug development paradigm consists of a rigorous step-wise process that takes place over many years. Although this approach results in access to safe and effective new products, it is both costly and inefficient. Therefore, interest has emerged in clinical pharmacology, specifically an understanding of the inter- and intra-individual variability in pharmacokinetics and pharmacodynamics, to increase the efficiency of drug development in inflammatory bowel disease. A firm understanding of cli...

Characterization of Comorbidities Limiting the Recruitment of Patients in Early Phase Clinical Trials.

Early phase clinical trials evaluate the safety and efficacy of new treatments. The exclusion/inclusion criteria in these trials are usually rigorous and may exclude many patients seen in clinical practice. Our objective was to study the comorbidities limiting the participation of patients with breast, colorectal, or lung cancer in clinical trials.

Identifying Outcomes in Clinical Trials of Pouchitis for the Development of a Core Outcome Set.

Clinical SLEDAI-2K zero may be a pragmatic outcome measure in SLE studies.

Development of therapies for systemic lupus erythematosus (SLE) has in part been limited by the lack of suitable outcome measures in clinical trials. In the present post-hoc analysis of two clinical trials of belimumab, we investigated two potential outcomes, the Lupus Low Disease Activity State (LLDAS) and clinical SLE disease activity index 2000 (cSLEDAI-2K) zero, in relation to SLE responder index 4 (SRI-4).

Development of an Oculopressor to Evaluate the Efficiency of Glaucoma Drainage Devices.

Evaluation of the long-term efficiency of MIGS implants is still challenging, due to the lack of standardized clinical studies of stand-alone procedures. Moreover, the different mechanisms of the various glaucoma drainage devices are not adequately considered. The current study focusses on the development of a method for oculopression to evaluate the efficiency of glaucoma drainage devices.

Identifying Outcomes in Clinical Trials of Fistulizing Crohn's Disease for the Development of a Core Outcome Set.

Special Considerations for Clinical Trials in Fibrodysplasia Ossificans Progressiva (FOP).

Clinical trials for orphan diseases are critical for developing effective therapies. One such condition, fibrodysplasia ossificans progressiva (FOP; MIM#135100), is characterized by progressive heterotopic ossification (HO) that leads to severe disability. Individuals with FOP are extremely sensitive to even minor traumatic events. There has been substantial recent interest in clinical trials for novel and urgently-needed treatments for FOP. The International Clinical Council on FOP (ICC) was established in...

Synthesis of researcher reported strategies to recruit adults of ethnic minorities to clinical trials in the United Kingdom: A systematic review.

People from ethnic minorities are reported to have higher rates of physical illness (diabetes and ischemic heart disease) and mental disorders. Disparities relate not just to diagnosis, but also to care pathways and treatment outcomes. Despite this, they are underrepresented in clinical research. This reduces the generalisability of research findings across multi ethnic populations and hinders the development of accessible services. Researchers often face difficulties in recruiting ethnic minority participa...

Self-Selected walking speed increases when individuals are aware of being recorded.

Typical gait data collections consist of discrete walking trials where participants are aware when data are being recorded. Anecdotally, some investigators have reported that participants often walk differently between trials or before or after data collection compared to when they know they are being recorded. In addition, walking speed, which affects a number of gait variables, is known to be different when individuals complete discrete and continuous walking trials.

Paediatric Extrapolation: A Necessary Paradigm Shift.

Legislative initiatives have been successful in increasing the availability of approved therapies for paediatric patients. However, additional measures to ensure the timely completion of paediatric studies are necessary to further increase the number of medicines available to children. Over the last three years, international experts convened to revise the ICH E11 guideline on clinical investigations of medicinal products in paediatric populations to harmonise approaches to paediatric extrapolation, strivin...

Ethical Acceptability of Postrandomization Consent in Pragmatic Clinical Trials.

Pragmatic clinical trials that seek informed consent after randomization (ie, postrandomization consent) are increasingly used, but debate on ethics persists because control arm patients are not specifically informed about the trials and randomization occurs before consent for the trials. The public's attitude toward postrandomization consent trials is unknown, but the way the trials are described could bias people's views.

Publication of lung cancer clinical trials in the Japanese Clinical Trial Registry.

Since June 2005, the University Hospital Medical Information Network-Clinical Trial Registry (UMIN-CTR) has been an International Committee of Medical Journal Editors (ICMJE)-approved clinical trial registry in Japan. The number of clinical trials registered in the UMIN-CTR has increased annually. To date, no report exists regarding the publishing of clinical trials registered in the UMIN-CTR. Therefore, we evaluated the publication frequency of clinical trials registered in the UMIN-CTR in Japan.

'Optimism bias' in contemporary national clinical trial network phase III trials: are we improving?

Previous studies have found that overestimating treatment effects (i.e. 'optimism bias') leads to underpowered clinical trials. The prevalence of 'optimism bias' in contemporary National Clinical Trials Network (NCTN) cancer clinical trials is unknown.

Adaptive Seamless Design for Establishing Pharmacokinetic and Efficacy Equivalence in Developing Biosimilars.

Recently, numerous pharmaceutical sponsors have expressed a great deal of interest in the development of biosimilars, which requires clinical trials to demonstrate that the pharmacokinetic (PK) and clinical efficacy are equivalent. Pharmacodynamics (PD) may be used in evaluating efficacy if there are relevant PD markers available. However, in their absence, it is necessary to design the associated clinical trials to include efficacy measures as the primary endpoint.

Late translational research: putting forward a new model for developing new anti-cancer treatments that addresses the needs of patients and society.

Bringing therapeutic innovation and the latest science to routine patient care, whilst safeguarding principles of affordability and equality, is a challenging mission in the current complex multi-stakeholder environment. Precision oncology and new approaches to clinical trials (methods and clinical setting) have dramatically changed clinical research and the clinical development of new treatments. Improved understanding of molecular biology and immunology pave the way for innovative pharmacological approach...

Did relaxing clinical trial regulation enhance the stock of scientific knowledge in India? Not necessarily.

The increasing amount of clinical research conducted outside the "traditional" countries raises questions about the benefits of hosting offshored clinical research. The extent to which trials contribute to the scientific knowledge base and, in particular, whether there are differences between different types of trials remain open questions. By examining a change in clinical trial regulations in India, a country often viewed as a first-choice offshoring location, we study how the relaxation of clinical trial...

Correlating efficacy and immunogenicity in malaria vaccine trials.

The availability of an effective and appropriately implemented malaria vaccine would form a crucial cornerstone of public health efforts to fight this disease. Despite many decades of research, however, no malaria vaccine has yet shown satisfactory protective efficacy or been rolled-out. Validated immunological substitute endpoints have the potential to accelerate clinical vaccine development by reducing the required complexity, size, duration and cost of clinical trials. Besides facilitating clinical devel...

Multidisciplinary development of the Geriatric Core Dataset for clinical research in older patients with cancer: A French initiative with international survey.

To define a core set of geriatric data to be methodically collected in clinical cancer trials of older adults, enabling comparison across trials.

Huntington's Disease Clinical Trials Corner: January 2019.

In this edition of the Huntington's Disease Clinical Trials Corner we expand on the GENERATION-HD1 and PACE-HD trials, and we list all currently registered and ongoing clinical trials in Huntington's disease.

Accelerated Growth of Cellular Therapy Trials in Musculoskeletal Disorders: An Analysis of the NIH Clinical Trials Data Bank.

The purpose of this study was to (1) determine the growth rate and the trends of musculoskeletal cellular therapy trials in the National Institutes of Health Clinical Trials Data Bank; (2) analyze the study design and characteristics; and (3) assess which cellular therapies and disease conditions are studied. A systematic review of musculoskeletal clinical trials from 2005 to 2016 using cell-based therapies as the primary intervention was performed through The number of musculoskeletal c...

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