Skip to main content


Comparing the use of traditional and agile development methodologies in a clinical trials environment

Article metrics

  • 1358 Accesses

Computer systems used for clinical trials need to have documented evidence that they are validated systems. This is a formal process that assures users (and regulatory inspectors) that the system is fit for purpose. At MRC CTU, we have successfully met this requirement for the past ten years using the traditional waterfall method of software development, which produces agreed documentation at each stage of the life cycle, in sequential order. However, we often find that requirements for a trial can change during development, which adversely affects timelines and increases the documentation burden. Agile development methods are designed to produce smaller quicker deliverables, which is attractive, but are typically less formal in the documentation produced, which present a challenge when working in a regulated environment. We explore the advantages and disadvantages of several flavours of these methodologies, assembling best practice to optimise efficiency and compliance, and describe the implementation of this methodology in some of our newer trials.

Author information

Correspondence to Mary Rauchenberger.

Rights and permissions

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Reprints and Permissions

About this article

Cite this article

Rauchenberger, M., Little, E. & Montana, C.D. Comparing the use of traditional and agile development methodologies in a clinical trials environment. Trials 14, P65 (2013) doi:10.1186/1745-6215-14-S1-P65

Download citation


  • Public Health
  • Clinical Trial
  • Life Cycle
  • Computer System
  • Formal Process


By submitting a comment you agree to abide by our Terms and Community Guidelines. If you find something abusive or that does not comply with our terms or guidelines please flag it as inappropriate. Please note that comments may be removed without notice if they are flagged by another user or do not comply with our community guidelines.