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Smart Labels in the Clinical Trial Supply Chain

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Smart Labels in the Clinical Trial Supply Chain Smart Labels in the Clinical Trial Supply Chain Ignacio Paricio 1 Smart Labels in the Clinical Trial Supply Chain by Ignacio Paricio In partial fulfillment of the requirements for the degree of Master of Science in Engineering and Policy Analysis at the Delft University of Technology, to be defended publicly on 30 June 2016. Graduation Committee First supervisor: Dr. ir. B. Enserink TU Delft Second supervisor: Dr. J. Rezaei TU Delft Chair: Prof.dr.ir. A. Verbraeck TU Delft External supervisor: A. Bachmann Novartis Pharma AG An electronic version is available at http://repository.tudelft.nl i ii Preface This document is the end result of my Master thesis, carried out between February and June 2016 in Basel, Switzerland, which explores the benefits that new technologies can bring to the design and execution of clinical trials. The thesis is written in such a way that everyone without any prior background in pharmacy can progressively build knowledge to end up understanding complex logistics issues that affect clinical trial supply chains. I myself had little knowledge about the pharmaceutical sector before I joined Novartis in February 2016, and have tried to create a report that captures the learning curve I went through, while at the same time inviting the reader to take part in the same process. This is especially true for the extended introduction provided in the first chapter, which is recommended to all the readers without prior experience in the pharma industry. Readers with an advanced knowledge or direct experience in the pharmaceutical sector will surely find the conclusions of the third and the sixth chapter the most interesting ones, as they focus on the analysis of a particular type of smart label suitable for the clinical trial supply chain which has not been explored so far. Furthermore, the final conclusions and recommendations presented in the eighth chapter are a shortcut to all the outcomes of this thesis. Finally, readers with an interest in the discrete-event simulation approach adopted to model a clinical trial supply chain will find plenty of explanations on the model conceptualization in the fifth chapter, as well as in an appendix dedicated to the model specification. Ignacio Paricio Basel, June 2016 iii iv Acknowledgements I would like to express my deepest gratitude to Amanda Bachmann, my external supervisor at Novartis, for her continuous support and priceless input during our talks and discussions throughout my stay at Novartis. I would also like to thank all the interviewees from Novartis that dedicated time to support my research. Their input has been crucial to clarify concepts, gather input data and validate the outcomes of this thesis. Thanks also to the members of my Thesis Committee at TU Delft – Alexander Verbraeck, Bert Enserink and Jafar Rezaei – for their support, thoughtful questions and comments. Their feedback was greatly appreciated and served to improve the quality of this thesis. Finally, I would like to thank my closest family for being always there throughout my education. Ignacio Paricio Basel, June 2016 v vi Smart Labels in the Clinical Trial Supply Chain Acronyms .................................................................................................................................................. xi List of figures ........................................................................................................................................... xiii List of tables ........................................................................................................................................... xvii Executive Summary .................................................................................................................................xix 1 Introduction – From Healthcare Quality to the Clinical Trial Supply Chain ................................. 1 1.1 Drug development and its importance for a better healthcare quality – An overview ..........2 1.2 The drug development process of pharmaceutical companies ...............................................2 1.3 Clinical trials: when a candidate drug first meets humans ......................................................5 1.4 Supply chain management and the clinical trial supply chain ................................................6 1.5 The material flow of the clinical trial supply chain ...................................................................7 1.6 The information flow of the clinical trial supply chain .............................................................9 1.7 Stakeholders involved in the clinical trial industry ................................................................ 10 1.8 Challenges faced in the clinical trial industry ......................................................................... 18 2 Research Definition......................................................................................................................... 23 2.1 The potential disruptive role of new technologies in clinical trials ...................................... 24 2.2 Scope, research objective and research questions ................................................................. 24 2.3 Methodology .............................................................................................................................. 25 2.4 Research relevance .................................................................................................................... 27 2.5 Expected outcomes and research plan .................................................................................... 27 2.6 Research limitations .................................................................................................................. 28 3 Smart labels – Market Research and Applicability to the Clinical Trial Supply Chain ................ 29 3.1 Deeper insights into the role of labeling in clinical trials ...................................................... 30 3.2 Market research on smart labels .............................................................................................. 31 3.3 Research on smart labels in the pharmaceutical industry .................................................... 40 3.4 SWOT of the different applications of smart labels in the clinical trial supply chain ......... 43 3.5 Smart labels in the clinical trial supply chain – Conclusions ................................................ 48 4 The Regulatory Perspective: Do Smart Labels Fit in the Current Regulatory Framework?......... 51 4.1 Overview of regulatory aspects in clinical trials ..................................................................... 52 4.2 Labeling requirements for IMPs in clinical trials ................................................................... 55 4.3 Outcomes of the interviews with experts in clinical trial regulations................................... 60 4.4 The regulatory perspective on smart labels – Discussion and conclusions ......................... 60 vii 5 A Discrete-Event Simulation Model of the Clinical Trial Supply Chain ....................................... 65 5.1 Optimization techniques for the clinical trial supply chain – A literature review ................ 66 5.2 The clinical trial supply chain – Model conceptualization ..................................................... 67 5.3 Model boundaries ...................................................................................................................... 77 5.4 Assumptions taken and their justification ............................................................................... 78 5.5 Key Performance Indicators ...................................................................................................... 80 5.6 Modeling logic in Simio – different objects and model parameters ...................................... 81 5.7 Model verification and validation ............................................................................................. 82 6 Case Study: Smart Labels on a Phase III Clinical Trial ................................................................... 85 6.1 Overview of the case .................................................................................................................. 86 6.2 The status quo – analysis and optimization of the safety stock ............................................. 87 6.3 Implementing smart labels in the clinical trial supply chain ................................................. 91 6.4 Effects that different parameters have in the usefulness of smart labels .............................. 93 6.5 Price of eInk smart labels ........................................................................................................... 99 6.6 Other opportunities and threats not captured in the model ................................................ 100 6.7 Case Study: Smart Labels on a Phase III Clinical Trial – Conclusions ................................. 101 7 Smart Labels in Clinical Trials – The Patient Perspective ............................................................ 103 7.1 Literature review on the motivations and barriers for trial participation and adherence 104 7.2 Smart labels to improve patient adherence ........................................................................... 111 7.3 Smart labels to reduce the time burden for patients participating in a clinical trial ......... 116 7.4 Critical assumptions and risks in the implementation of patient-oriented technology ... 117 7.5 The patient
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