Dataset Information

Clinical Trial Data Management in Environmental Health Tailored for an African Setting.

ABSTRACT: Clinical trial data management tools are widely available-some free to access and others relatively expensive, particularly for low- and middle-income countries. Such tools also do not always permit adaptation for local conditions nor include options to capture environmental and meteorological data. In the context of climate change and pressing environmental health threats, more studies that aim to assess the impacts of environmental change on public health are being carried out. Here, using freely available software, we tailor-made a clinical trial data management tool that managed all aspects of an intervention-based clinical trial to assess the impact of personal solar ultraviolet radiation exposure on vaccine effectiveness. Data captured and associated procedures included patient data, scheduling, reporting, analysis and data management. Moreover, patient enrolment, recruitment, follow-up and decision-making in response to patient data were managed. Given the multidisciplinary study approach, the tool also managed all environmental and meteorological data for the rural African study site. Application of the tool ensured efficient communication between rural sites, a relatively high overall participant response rate (87%) and minimal loss to follow-up. This study suggests that it is possible to tailor-make a clinical trial data management tool for environmental and public health studies.

SUBMITTER: Albers PN

PROVIDER: S-EPMC7013767 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Clinical Trial Data Management in Environmental Health Tailored for an African Setting.

Albers Patricia Nicole PN Wright Caradee Yael CY

International journal of environmental research and public health 20200108 2

Clinical trial data management tools are widely available-some free to access and others relatively expensive, particularly for low- and middle-income countries. Such tools also do not always permit adaptation for local conditions nor include options to capture environmental and meteorological data. In the context of climate change and pressing environmental health threats, more studies that aim to assess the impacts of environmental change on public health are being carried out. Here, using fre ...[more]

PMID: 31936227

Similar Datasets

Project description:BackgroundClinical trials are often perceived as being expensive, difficult and beyond the capacity of healthcare workers in low-resource settings. However, in order to improve healthcare coverage, the World Health Organization (WHO) World Health Report 2013 stated that all countries need to become generators as well as recipients of data. This study is a methodological examination of the steps and processes involved in setting up the Gojjam Lymphoedema Best Practice Trial (GoLBeT; ISRCTN67805210), a highly pragmatic clinical trial conducted in northern Ethiopia. Challenges to the trial and strategies used to deal with them were explored, together with the reasons for delays.Methodology and principal findingsQualitative research methods were used to analyse emails and reports from the period between trial inception and recruitment. This analysis was complemented by interviews with key informants from the trial operational team. The Global Health Research Process Map was used as a framework against which to compare the steps involved in setting up the trial. A mini-group discussion was conducted with the trial operational team after study completion for reflection and further recommendations. This study showed that the key areas of difficulty in setting up and planning this trial were: the study design, that is, deciding on the study endpoint, where and how best to measure it, and assuring statistical power; recruitment and appropriate training of staff; planning for data quality; and gaining regulatory approvals. Collaboration, for example with statisticians, the trial steering committee, the study monitors, and members of the local community was essential to successfully setting up the trial.Conclusions and significanceLessons learnt from this trial might guide others planning pragmatic trials in settings where research is not common, allowing them to anticipate possible challenges and address them through trial design, planning and operational delivery. We also hope that this example might encourage similar pragmatic studies to be undertaken. Such studies are rarely undertaken or locally led, but are an accessible and efficient way to drive improved outcomes in public health.

Dataset Information

Clinical Trial Data Management in Environmental Health Tailored for an African Setting.

Publications

Clinical Trial Data Management in Environmental Health Tailored for an African Setting.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets