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Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study

In November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). However, recent evidence suggests that a ‘gold standard’, validated approach to RBM does not exist and it is unclear how sponsors will introduce RBM into their ...

The use of anti stretch marks’ products by women in pregnancy: a descriptive, cross-sectional survey

Background Stretch marks (Striae gravidarum) are a cutaneous change occurring commonly during pregnancy. A variety of products are available and promoted as ways to prevent or reduce their development, but it is not clear what products are used most commonly. The objective of this study was to identify topical products used during pregnancy to prevent or reduce the development of ...

Recruiting faith- and non-faith-based schools, adolescents and parents to a cluster randomised sexual-health trial: experiences, challenges and lessons from the mixed-methods Jack Feasibility Trial

Background The move toward evidence-based education has led to increasing numbers of randomised trials in schools. However, the literature on recruitment to non-clinical trials is relatively underdeveloped, when compared to that of clinical trials. Recruitment to school-based randomised trials is, however, challenging, even more so when the focus of the study is a sensitive issue ...

Core outcome sets and trial registries

Some reasons for registering trials might be considered as self-serving, such as satisfying the requirements of a journal in which the researchers wish to publish their eventual findings or publicising the trial to boost recruitment. Registry entries also help others, including systematic reviewers, to know about ongoing or unpublished studies and contribute to reducing research ...

How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline

Maarten Boers 0 Peter Tugwell Mike Clarke Paula R. Williamson Caroline B. Terwee 0 0 Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Center

Recruiting schools, adolescents and parents to a sexual-health trial: experiences, challenges and lessons learned from the Jack Trial (NCT02092480)

Mike Clarke Maria Lohan Queen's University Belfast, Northern Ireland, UK Background Recruitment to school-based randomised trials is challenging; even more so when the focus of the study is a sensitive

The COMET initiative database: progress and activities update (2014)

The COMET Initiative database is a repository of studies relevant to the development of core outcome sets (COS). Use of the website continues to increase, with more than 16,500 visits in 2014 (36 % increase over 2013), 12,257 unique visitors (47 % increase), 9780 new visitors (43 % increase) and a rise in the proportion of visits from outside the UK (8565 visits; 51 % of all ...

Collating the knowledge base for core outcome set development: developing and appraising the search strategy for a systematic review

Background The COMET (Core Outcome Measures in Effectiveness Trials) Initiative is developing a publicly accessible online resource to collate the knowledge base for core outcome set development (COS) and the applied work from different health conditions. Ensuring that the database is as comprehensive as possible and keeping it up to date are key to its value for users. This ...

Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial

Background Individual patient data (IPD) meta-analysis is considered the “gold standard” for exploring the effectiveness of interventions in different subgroups of patients. However, obtaining IPD is time-consuming and contact with the researchers responsible for the original trials is usually required. To date, there are no studies evaluating different strategies to optimize the ...