The document summarizes key topics from a conference on clinical trial performance metrics. It discusses using metrics to improve employee performance and productivity, providing essential training in project management methodology. It also addresses involving metrics early in a new employee's work and balancing individual metrics for employees. An example is given of life with metrics for medical writers at a clinical research organization.

1. 5th Annual
Clinical Trial Performance Metrics
Using metrics to improve performance and productivity
20-21 February 2008, London, UK

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
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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
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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
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5. 5 21st February 2008 London
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6. TIME QUALITY
MONEY
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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
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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
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9. Individual metrics for the individual employee?
Stahanov
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10. 10 21st February 2008 London
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11. 11 21st February 2008 London
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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
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13. Life with metrics for medical writers
Graduating
Recruiting
Training
Retaining
Karen Wooley, CEO ProScribe Medical Communications
Associate Professor, University of Queensland
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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.”
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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 …”
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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
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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.
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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
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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
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20. Technical skills – relatively easy, timely feedback
Writing skills – much harder and very time consuming
Thinking skills
Behaviour?
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21. Diana Andreeva Taylor
Author, Berlin
http://healthywords.edublogs.org
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22. Thank you