Working towards consensus on methods used to elicit participant-reported safety data in uncomplicated malaria clinical drug studies: a Delphi technique study
详细信息 查看全文
- 作者：Nyaradzo Mandimika ; Karen I. Barnes ; Clare I. R. Chandler ; Cheryl Pace…
- 关键词：Elicitation methods ; Clinical trials ; Safety ; Adverse events ; Non ; study medication ; Delphi
- 刊名：Malaria Journal
- 出版年：2017
- 出版时间：December 2017
- 年：2017
- 卷：16
- 期：1
- 全文大小：832KB
- 刊物主题：Parasitology; Tropical Medicine; Infectious Diseases; Entomology; Microbiology; Public Health;
- 出版者：BioMed Central
- ISSN：1475-2875
- 卷排序：16
文摘
BackgroundEliciting adverse event (AE) and non-study medication data reports from clinical research participants is integral to evaluating drug safety. However, using different methods to question participants yields inconsistent results, compromising the interpretation, comparison and pooling of data across studies. This is particularly important given the widespread use of anti-malarials in vulnerable populations, and their increasing use in healthy, but at-risk individuals, as preventive treatment or to reduce malaria transmission.