A5073797545- Statistical Methods in Clinical Trials
- Optimal Experimental Design Methods
- Health Systems, Economic Evaluations, Quality of Life
- Advanced Causal Inference Techniques
- Statistical Methods and Inference
- Advanced Statistical Process Monitoring
- Computational Drug Discovery Methods
- Biosimilars and Bioanalytical Methods
- Statistical Methods and Bayesian Inference
- Drug Solubulity and Delivery Systems
- Clinical Nutrition and Gastroenterology
- Cultural Industries and Urban Development
- Clinical Laboratory Practices and Quality Control
- Infant Nutrition and Health
- HIV/AIDS drug development and treatment
- Pharmaceutical Economics and Policy
- Prenatal Substance Exposure Effects
- Gastrointestinal motility and disorders
- Ethics in Clinical Research
- Pharmaceutical studies and practices
- Lymphoma Diagnosis and Treatment
- HER2/EGFR in Cancer Research
- Viral gastroenteritis research and epidemiology
- Meta-analysis and systematic reviews
- Diabetes Management and Research
King's College London
2022-2023
American College of Clinical Pharmacy
2019
University College Hospital
2018
University College London
2014-2018
The Royal Free Hospital
2010
Vifor Pharma (United Kingdom)
2006
Fondation pour la Recherche Médicale
2006
Association pour l'Utilisation du Rein Artificiel dans la région Lyonnaise
2006
Philips (Finland)
1999-2000
Huntercombe Hospital
1998
ICH E9 Statistical Principles for Clinical Trials was issued in 1998. In October 2014, an addendum to proposed relating estimands and sensitivity analyses. preparation the release of addendum, Statisticians Pharmaceutical Industry held a 1‐day expert group meeting February 2015. Topics debated included definition, development, implementation, education communication challenges associated with The topic is important relatively new one clinical development. A clear message from that bridge gap...
Abstract The International Conference on Harmonization (ICH) E9 guideline ‘Statistical principles for clinical trials’ was adopted by the Committee Proprietary Medicinal Products in March 1998, and consequently is operational Europe. It has also been U.S.A. Japan. aim of this paper to relate problems encountered during a recent regulatory submission those discussed ICH guideline. Statistical guideline, but not comprehensively addressed when development programme initiated mid‐1990s, will be...
The Points to Consider Document on Missing Data was adopted by the Committee of Health and Medicinal Products (CHMP) in December 2001. In September 2007 CHMP issued a recommendation review document, with particular emphasis summarizing critically appraising pattern drop-outs, explaining role limitations 'last observation carried forward' method describing CHMP's cautionary stance use mixed models. preparation for release updated guidance statisticians Pharmaceutical Industry held one-day...
In May 2012, the Committee of Health and Medicinal Products issued a concept paper on need to review points consider document multiplicity issues in clinical trials. preparation for release updated guidance document, Statisticians Pharmaceutical Industry held one‐day expert group meeting January 2013. Topics debated included drug development process, usefulness limitations newly developed strategies deal with multiplicity, arising from interim decisions multiregional development,...
This position statement summarises a view of academia regarding standards for clinical research in collaboration with commercial enterprises, focussing on trials pregnant women, breast-feeding and children. It is based review the available literature an expert workshop cosponsored by Early Nutrition Academy European Society Pediatric Gastroenterology, Hepatology, Nutrition. Clinical collaborations between academic investigators enterprises are encouraged universities, public funding...
The year 1968 is often considered to be one of the most turbulent in 20th century. It began with Tet Offensive midst second part Vietnam War, it was followed by assassination Dr Martin Luther King, Jr, and soon after that Robert F. Kennedy. Mass socialist movements grew not only United States but also European countries. spectacular manifestation this May protests France, which students linked up wildcat strikes 10 million workers, for a few days movement seemed capable overthrowing...
The European Agency for the Evaluation of Medicinal Products has recently completed consultation a draft guidance on how to implement conditional approval. This route application is available orphan drugs, emergency situations and serious debilitating or life-threatening diseases. Although there been limited experience in implementing approval date, PSI (Statisticians Pharmaceutical Industry) sponsored meeting pharmaceutical statisticians with an interest area discuss potential issues....
Abstract This short communication presents a first in human Bayesian Optimal Interval design case study. The study and associated operating characteristics are discussed, together with amendments proposed whilst the was ongoing. Simulations investigating impact of on presented. Lessons learnt from study, including providing practical advice when designing smarter early phase oncology trials to identify maximum tolerate dose also summarised. It is argued that model‐assisted designs simple...
The basis of sample size calculations is usually needed in protocols for clinical trials and when publishing results respected journals. Although a large amount research has been undertaken on estimation different trial designs, practice the methods are rarely used. This paper describes some useful theory that practical relevance.
Abstract The International Conference on Harmonisation guideline ‘Statistical Principles for Clinical Trials’ was adopted by the Committee Proprietary Medicinal Products (CPMP) in March 1998, and consequently is operational Europe. Since then more detailed guidance selected topics has been issued CPMP form of ‘Points to Consider’ documents. intent these give particularly non‐statistical reviewers within regulatory authorities, although course they also provide a good source information...
This short communication supports that rule-based study designs such as the '3 + 3' design are still being used in early phase oncology development programs despite their inferior performance to model-based and model-assisted designs. Statisticians have an opportunity shape improve drug by introducing newer, more efficient estimate Optimal Biological dose trialist colleges.