Abstract:

Background: In clinical trials, turnaround time, data accuracy and quality are critical for developing safe and new medicine for patients. The cost of a one-day delay in a drug being brought to the market can be in millions.¹ It is essential; therefore, that all stakeholders in clinical trials take steps forward to improve efficiency, accuracy and quality of the clinical research overall. Doing so requires that organizations look beyond symptoms to uncover the true causes of errors in quality and delays. Additionally, new processes must be implemented in such a way as to become part of institutional culture, ensuring the consistent, on-going success of future efforts.

Purpose/Aim: To integrate, study and develop a stable, robust and reproducible Quality Management System (QMS) using combined quality management techniques such as Six Sigma, ISO and Lean together in clinical research.

Methods: Group of Students and working professionals will be asked to assess these three techniques individually and combined using pre-defined, developed and validated paper questionnaires. Different studies will be conducted over the period of 6-18 months and data will be collected. These studies will have an objective of testing each of three techniques on established processes to see if these can be used for process improvements. Result of these studies and quality matrix will be looked at to see how Six Sigma, ISO and Lean work independently and in combination of each other at the same time. Validated questionnaires will be used to obtain the results. Any survey tool developed will be piloted before using in the main phase of the study. Model needs will vary according to level of accessibility and sub-techniques, and this will need to be considered when selecting the sample for detailed study. Standard statistical packages will be used for examination. Standard qualitative and qualitative data analysis software package will be used to interpret the data generated form the review, questionnaire and interviews.

Conclusions: It is expected from proposed studies that combined use of ISO, Lean and Six Sigma techniques can improve quality of processes, data and produce robust Quality Management System.

These three techniques are different but complement each other. It is anticipated that a combination of these techniques will be of a great magnitude and beneficial to clinical research.

References:

[1]. Applied Clinical Trials; Retrieved on 06 October 2014,

http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=791938; Dawn Pope; Lean Six Sigma in the Clinical Trial Industry: Two Perspectives, published on 09 October 2012

[2]. ClinicalTrials.gov; Retrieved on 06 October 2014, https://clinicaltrials.gov/ct2/resources/trends

[3]. International Conference on Harmonization (ICH); Good Clinical Practice (GCP) E6 – Guidelines; retrieved on 06 October 2014, http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf

[4]. Lui EW. Clinical research: the Six Sigma way. J Assn Lab Automat 2006;11(1):42–49.

[5]. Chow-Chua, Clare; Goh, Mark; Wan, Tan Boon (2003). "Does ISO 9000 certification improve business performance?". International Journal of Quality & Reliability Management 20 (8): 936.

[6]. Cynthis F. Kleppinger; Leslie K. Ball. Building Quality in Clinical Trials With Use of Quality Systems Approach; Journal of Clinical Infectious Diseases 2010; 51(S1):S111–S116.

[7]. Zidel, Tom (2006), A Lean Guide to Transforming Healthcare ISBN 0-87389-701-3