5th Annual
Clinical Trial Performance Metrics

 Using metrics to improve performance and productivity
 20-21 February 2008...
Objectives of metrics

    "Project Management in Clinical Trials" will provide presentations aimed to help
    you learn ...
Involving metrics early in a new employee’s work:
risks and benefits



     The dual nature of metrics and performance - ...
The scores of “killed”
                                                John Mueller holds the Woody Hayes Chair of
       ...
5   21st February 2008 London
           Diana Taylor
TIME                               QUALITY




             MONEY

6          21st February 2008 London
                  ...
Metrics and performance

    Pennsylvania, Philadelphia, Germantown, 1878              Frederick Winslow Taylor

    Scien...
Frederick Winslow Taylor

    Improvement of efficiency and maximisation of profit

    Ethical behaviour of people toward...
Individual metrics for the individual employee?

    Stahanov




9                  21st February 2008 London
           ...
10   21st February 2008 London
            Diana Taylor
11   21st February 2008 London
            Diana Taylor
Metrics and CRO

     Miriam Shuchman, M.D.
     Commercializing Clinical Trials — Risks and Benefits of the CRO Boom
    ...
Life with metrics for medical writers

     Graduating

     Recruiting

     Training

     Retaining




Karen Wooley, C...
Graduating
     NY Times 7 December 2004 “What corporate America can’t build: a sentence”

“National Commission on Writing...
Graduating
     NY times 21 January 2008 “New York measuring teachers by test scores”

     2,500 teachers in New York Cit...
Graduating



     educators nationwide are struggling to figure out
     how to find, train and measure good teachers –
 ...
How to determine what makes a good medical writer

     Education

     Academic records

     Certification

     “excell...
Requirements for a Medical Writer

     Application documents

         PhD, publications, flawless cover letter and CV, e...
Requirements for a Medical Writer

     Knowledge of Laws and Regulations

         ICH Guidelines
           − ICH E3
   ...
Technical skills – relatively easy, timely feedback

     Writing skills – much harder and very time consuming

     Think...
Diana Andreeva Taylor
Author, Berlin




http://healthywords.edublogs.org




21                           21st February 2...
Thank you
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London Presentation on Metrics, 2008

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Slideshare London Metrix21022008

  1. 1. 5th Annual Clinical Trial Performance Metrics Using metrics to improve performance and productivity 20-21 February 2008, London, UK
  2. 2. 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. … providing essential training in … PRINCE2 project management methodology, this event is vital to project management success. 2 21st February 2008 London Diana Taylor
  3. 3. Involving metrics early in a new employee’s work: risks and benefits The dual nature of metrics and performance - balancing the odds Individual metrics for the individual employee? Life with metrics for medical writers at a CRO: an example 3 21st February 2008 London Diana Taylor
  4. 4. The scores of “killed” John Mueller holds the Woody Hayes Chair of National Security Studies at Ohio State University 250 200 150 100 50 0 Total killed Killed shirt Killed Shirt Good killed Sex Scenes ON OFF by bad Rambo 1 2 3 4 4 21st February 2008 London Diana Taylor
  5. 5. 5 21st February 2008 London Diana Taylor
  6. 6. TIME QUALITY MONEY 6 21st February 2008 London Diana Taylor
  7. 7. Metrics and performance Pennsylvania, Philadelphia, Germantown, 1878 Frederick Winslow Taylor 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 7 21st February 2008 London Diana Taylor
  8. 8. 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 8 21st February 2008 London Diana Taylor
  9. 9. Individual metrics for the individual employee? Stahanov 9 21st February 2008 London Diana Taylor
  10. 10. 10 21st February 2008 London Diana Taylor
  11. 11. 11 21st February 2008 London Diana Taylor
  12. 12. Metrics and CRO Miriam Shuchman, M.D. Commercializing Clinical Trials — Risks and Benefits of the CRO Boom NEJM Volume 357:1365-1368 October 4, 2007, Number 14 12 21st February 2008 London Diana Taylor
  13. 13. Life with metrics for medical writers Graduating Recruiting Training Retaining Karen Wooley, CEO ProScribe Medical Communications Associate Professor, University of Queensland 13 21st February 2008 London Diana Taylor
  14. 14. 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.” 14 21st February 2008 London Diana Taylor
  15. 15. Graduating NY times 21 January 2008 “New York measuring teachers by test scores” 2,500 teachers in New York City are being measured on how much their students improve on annual standardised tests; Objective: to determine how much a teacher has contributed to students’ growth Primary variables: “predicted gain” for a teacher’s class against students’ actual gains Design: parallel groups of teachers in 2 x 140 schools 1) teachers are judged by students’ achievements: how many students in their classes meet basic progress goals how much student performance grows each year how that improvement compares with the performance of similar students with other teachers 2) principles make subjective evaluations Results: teachers ratings will be made public Conduct: teachers have not been told, data have already been collected, no previous announcement on how these results will be used, but eventually for: performance evaluation, bonus allocation, tenure/redundancies Weaknesses: “These tests were never intended and have never been validated for the use of evaluating teachers.” “There is no way that any of this current data could actually, fairly, honestly or with any integrity be used to isolate the contributions of an individual teacher.” “It is going to tell you some things you don’t know, but it will miss the other things that go on …” 15 21st February 2008 London Diana Taylor
  16. 16. Graduating educators nationwide are struggling to figure out how to find, train and measure good teachers – who teach well or who force students to learn well? finding high-quality teachers is crucial to improving student learning 16 21st February 2008 London Diana Taylor
  17. 17. 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. 17 21st February 2008 London Diana Taylor
  18. 18. Requirements for a Medical Writer Application documents PhD, publications, flawless cover letter and CV, evidence of documents written, references from previous employers, web presence Technical skills Reading and understanding listings, tables and figure Summarising data into text Designing tables and figures Designing templates Computer skills 18 21st February 2008 London Diana Taylor
  19. 19. 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 19 21st February 2008 London Diana Taylor
  20. 20. Technical skills – relatively easy, timely feedback Writing skills – much harder and very time consuming Thinking skills Behaviour? 20 21st February 2008 London Diana Taylor
  21. 21. Diana Andreeva Taylor Author, Berlin http://healthywords.edublogs.org 21 21st February 2008 London Diana Taylor
  22. 22. Thank you

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