Comparison of two data collection processes in clinical studies: electronic and paper case report forms

BMC Medical Research Methodology

Isabelle Durand-Zaleski²  Corinne Alberti³  Céline Quelen¹  Anaïs Le Jeannic¹ 

[1] Département de la recherche clinique et du développement, AP-HP, Groupe hospitalier Cochin Hôtel-Dieu, URC Économie de la Santé Ile de France, F-75004 Paris, France;Service de Santé Publique, AP-HP, Groupe hospitalier Albert Chenevier- Henri Mondor, F-94010 Créteil, France;Université Paris Diderot, PRES Sorbonne Paris Cité, F-75019 Paris, France

关键词: Work satisfaction;    Time management;    Costs;    Electronic data collection;   

Others  :  866498
DOI  :  10.1186/1471-2288-14-7

 received in 2013-04-11, accepted in 2013-12-31,  发布年份 2014

【 摘 要 】

Background

Electronic Case Report Forms (eCRFs) are increasingly chosen by investigators and sponsors of clinical research instead of the traditional pen-and-paper data collection (pCRFs). Previous studies suggested that eCRFs avoided mistakes, shortened the duration of clinical studies and reduced data collection costs.

Methods

Our objectives were to describe and contrast both objective and subjective efficiency of pCRF and eCRF use in clinical studies. A total of 27 studies (11 eCRF, 16 pCRF) sponsored by the Paris hospital consortium, conducted and completed between 2001 and 2011 were included. Questionnaires were emailed to investigators of those studies, as well as clinical research associates and data managers working in Paris hospitals, soliciting their level of satisfaction and preferences for eCRFs and pCRFs. Mean costs and timeframes were compared using bootstrap methods, linear and logistic regression.

Results

The total cost per patient was 374€ ±351 with eCRFs vs. 1,135€ ±1,234 with pCRFs. Time between the opening of the first center and the database lock was 31.7 months Q1 = 24.6; Q3 = 42.8 using eCRFs, vs. 39.8 months Q1 = 31.7; Q3 = 52.2 with pCRFs (p = 0.11). Electronic CRFs were globally preferred by all (31/72 vs. 15/72 for paper) for easier monitoring and improved data quality.

Conclusions

This study found that eCRFs and pCRFs are used in studies with different patient numbers, center numbers and risk. The first ones are more advantageous in large, low–risk studies and gain support from a majority of stakeholders.

【 授权许可】

   
2014 Le Jeannic et al.; licensee BioMed Central Ltd.

【 图 表 】

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