A US public-private partnership of more than 80 organizations from across the clinical trial enterprise established by the US Food and Drug Administration and Duke University in 2007, working together to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. Many resources, recommendations and tools have been developed (including quality by design, patient engagement and use of mobile technologies) and there are regular free webinars.
The COMET (Core Outcome Measures in Effectiveness Trials) Initiative brings together people interested in the development and application of agreed standardised sets of outcomes, known as ‘core outcome sets’ (COS). These sets represent the minimum that should be measured and reported in all clinical trials of a specific condition and are also suitable for use in clinical audit or research other than randomised trials. A database of all studies relevant to the development of COS for use in clinical trials and a handbook/guide for those wanting to develop a COS.
Founded in 1978 to stimulate research into the principles and methodology used in the design and analysis of clinical research and to increase the relevance of statistical theory to the real world of clinical medicine. Membership includes clinicians, statisticians and members of other disciplines, such as epidemiologists, clinical chemists and clinical pharmacologists, working or interested in the field of clinical biostatistics
A multidisciplinary society with membership spanning myriad disciplines that are all critical to the field of clinical trials: biostatistics, clinical areas, IT and systems, data management, ethics, regulatory bodies, behavioral science, research coordination, patient partners, health outcomes researchers, and many others
A network for students interested in evidence-based health care but useful information for anyone working in evidence-based healthcare. Useful tutorials on study design and research methods (e.g. heterogeneity), learning resources (e.g. Catalogue of Bias) and evidence reviews.
This initiative is identifying methods for trials and systematic reviews about which there is sufficient uncertainty to justify research to support well-informed decision making about designs and choices. A repository of existing SWATs can be found at the site. If you are interested in embedding methodology research into an ongoing trial and other prospective study, have a look at the SWAT (Studies Within A Trial) collection online to see examples, or to register a new SWAT.
Helping to promote critical thinking about the treatment claims that people encounter, provides access to learning resources contained in the Critical thinking and Appraisal Resource Library (CARL), identifying those that have been formally evaluated.
A non-profit organization collaborating across the biopharmaceutical research and development community to identify, prioritize, design and facilitate implementation of solutions to drive efficient, effective and high-quality delivery of new medicines. A focus on creating pragmatic solutions (e.g. templates, guidance, model frameworks and systems) that can be voluntarily adopted by stakeholders. Free webinars https://transceleratebiopharmainc.com/transcelerate-events/
A hugely rich resource of guidance outputs and publications concerning trials methodology research, including key areas for adaptive designs, health economics, health informatics, outcomes, statistical analysis, stratified medicine and trial conduct. In addition, regular conference and training opportunities (currently mainly UK-focused, but more being developed elsewhere in collaboration with the Global Health Network), links to UK qualification