Clinical Trial Performance Metrics Using metrics to improve performance and productivity

2011 Diana Taylor 2 Dr. Diana A. Taylor, MSc Geny Research Inc.

2011 Diana Taylor 3 Pretoria, SA

2011 Diana Taylor 4 Metrics – a background story Quote for the Month! “If you wish to achieve worthwhile things in your personal and career life, you must become a worthwhile person in your own self-development.” Brian Tracey

2011 Diana Taylor 5 Objectives of metrics  "Project Management in Clinical Trials" will provide presentations aimed to help you learn the importance of project manager tools, and how to overcome the trials in clinical trial recruitment, helping you to complete clinical trial projects on time and on budget.

2011 Diana Taylor 6 The scores of “killed” John Mueller holds the Woody Hayes Chair of National Security Studies at Ohio State University

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8 TIME QUALITY MONEY

2011 Diana Taylor 9 Metrics and performance  Pennsylvania, Philadelphia, Germantown, 1878  Scientific management in business  Measurement of industrial productivity  Maximal efficiency  Managers  Workers  Machines  Time and motion studies  Best methods for performing a task in the least amount of time Frederick Winslow Taylor

2011 Diana Taylor 10 Frederick Winslow Taylor  Improvement of efficiency and maximisation of profit  Ethical behaviour of people towards increase of their income  Increase of the company size to obtain the advantages of division of labour and specialisation of tasks  Cooperation between management and workers  Selection, training and development of workers  Cooperative and innovative workforce  Trained and qualified management  Enforcement of standardisation of methods

2011 Diana Taylor 11 Individual metrics for the individual employee?  Stahanov

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2011 Diana Taylor 14 Metrics and CRO Miriam Shuchman, M.D. Commercializing Clinical Trials — Risks and Benefits of the CRO Boom NEJM Volume 357: October 4, 2007, Number 14

2011 Diana Taylor 15 The true measure of clinical trials  Analysis paralysis – how to get the true measure of clinical trials Published by Les Rose on 20/07/11 clinical-trials Lord Kelvin: “When you can measure what you are speaking about, and express it in numbers, you know something about it.”

2011 Diana Taylor 16 Life with metrics for medical writers  Graduating  Recruiting  Training  Retaining Karen Wooley, CEO ProScribe Medical Communications Associate Professor, University of Queensland

2011 Diana Taylor 17 Graduating  NY Times 7 December 2004 “What corporate America can’t build: a sentence” “National Commission on Writing (US) … concluded that a third of employees in the nation’s blue-chip companies wrote poorly and that businesses were spending as much as $3.1billion annually on remedial training” “It’s not that companies want to hire Tolstoy … but they need people who can write clearly, and many employees and (job) applicants fall short of that standard.” “… are chaotically written, resulting in a whole cycle of confusion” banks send their employees on remedial writing courses because “… people now just let thoughts drool out...” (spoiled by writing SMS and on screen) and on business behaviour courses “Even C.E.O.’s need writing help … They’re in denial, and who’s going to argue with the boss?” “Considering how highly educated our people are, many can’t write clearly in their … work.”

2011 Diana Taylor 18 How to determine what makes a good medical writer  Education  Academic records  Certification  “excellent written communication skills” “right qualification on paper” Cannot assume that someone who writes well will be a great medical writer.

2011 Diana Taylor 19 Requirements for a Medical Writer  Technical skills  Reading and understanding listings, tables and figure  Summarising data into text  Designing tables and figures  Designing templates  Computer skills

2011 Diana Taylor 20 Requirements for a Medical Writer  Knowledge of Laws and Regulations  ICH Guidelines  ICH E3  ICH E6  European and National laws  The Declaration of Helsinki  Language skills  Translations  Editing  Proof reading

2011 Diana Taylor 21  Technical skills – relatively easy, timely feedback  Writing skills – much harder and very time consuming  Thinking skills  Behaviour?

2011 Diana Taylor 22 “The Ethics of Consent: Theory and Practice” Franklin Miller and Alan Wertheimer, editors, 2009, 416 pages, Oxford University Press, $49.95

2011 Diana Taylor 23  healthywords on Google  For a quick glance:  For more details:  For latest news:

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