Workflow in clinical trial sites & its association with near miss events for data quality: ethnographic, workflow & systems simulation.

Elias Cesar Araujo De Carvalho,Jatin Shah,Wederson Claudino,Luiz Fernando Lima Reis,Adelia Portero Batilana,Ricardo Pietrobon,Rafael A Schmerling

doi:10.1371/journal.pone.0039671

Abstract

BackgroundWith the exponential expansion of clinical trials conducted in (Brazil, Russia, India, and China) and VISTA (Vietnam, Indonesia, South Africa, Turkey, and Argentina) countries, corresponding gains in cost and enrolment efficiency quickly outpace the consonant metrics in traditional countries in North America and European Union. However, questions still remain regarding the quality of data being collected in these countries. We used ethnographic, mapping and computer simulation studies to identify/address areas of threat to near miss events for data quality in two cancer trial sites in Brazil.Methodology/Principal FindingsTwo sites in Sao Paolo and Rio Janeiro were evaluated using ethnographic observations of workflow during subject enrolment and data collection. Emerging themes related to threats to near miss events for data quality were derived from observations. They were then transformed into workflows using UML-AD and modeled using System Dynamics. 139 tasks were observed and mapped through the ethnographic study. The UML-AD detected four major activities in the workflow evaluation of potential research subjects prior to signature of informed consent, visit to obtain subject́s informed consent, regular data collection sessions following study protocol and closure of study protocol for a given project. Field observations pointed to three major emerging themes: (a) lack of standardized process for data registration at source document, (b) multiplicity of data repositories and (c) scarcity of decision support systems at the point of research intervention. Simulation with policy model demonstrates a reduction of the rework problem.Conclusions/SignificancePatterns of threats to data quality at the two sites were similar to the threats reported in the literature for American sites. The clinical trial site managers need to reorganize staff workflow by using information technology more efficiently, establish new standard procedures and manage professionals to reduce near miss events and save time/cost. Clinical trial sponsors should improve relevant support systems.

Highlights

While clinical trials have typically been conducted in developed countries such as the United States of America, developing countries have recently emerged as important new locations for clinical research [1]
Both sites were located in Brazil: the first being a clinicbased environment in the city of Rio de Janeiro with one Principle Investigator (PI) oncologist, two nurses clinical research coordinator (CRC), one pharmacist, one clinical research administrator and fourteen studies in phase III and the second being a hospital-based environment in Sao Paulo, with two PIs oncologists, two nurses CRCs, four pharmacists, one clinical research administrator and three studies in phase III
In ‘‘standardized process procedure’’ policy, we suggest the clinical trial administrative staff of each site to periodically revise their standard procedures and perform training with the research team when working with CRFs to decrease the creation of intermediate documents

Summary

Introduction

While clinical trials have typically been conducted in developed countries such as the United States of America, developing countries have recently emerged as important new locations for clinical research [1]. The BRIC countries (Brazil, Russia, India and China) and VISTA (Vietnam, Indonesia, South Africa, Turkey, and Argentina), with their large and ethnically diverse populations, have become major players in the globalization of clinical research [2]. Efforts to improve and ensure the production of high quality data in all countries are essential for enhancing their competitiveness as viable locations for the conduct of clinical trials, especially in light of previous studies that have linked research in developing countries with lower levels of data quality [3]. With the exponential expansion of clinical trials conducted in (Brazil, Russia, India, and China) and VISTA (Vietnam, Indonesia, South Africa, Turkey, and Argentina) countries, corresponding gains in cost and enrolment efficiency quickly outpace the consonant metrics in traditional countries in North America and European Union. We used ethnographic, mapping and computer simulation studies to identify/address areas of threat to near miss events for data quality in two cancer trial sites in Brazil

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