McCulleyCuppan ExLPharma presentation on agile review

1. The Concept of Agile Review Agile methodologies mostly applied to software development Practices extended by Nokia to the authoring/reviewing of technical documentation 1

2. The Approach Nokia recognized traditional document approaches primarily rely on inspection not review to verify the quality of the documentation Approach—get people involved in the documentation process earlier to ensure communication quality calendar time efficiency commitment 2

3. Agile Review Agile review concentrates only on the critical document content that fulfills a narrowly defined purpose Review focus at the exclusion of the rest of the document content 3

4. Agile Review Driven by extension of Pareto’s 80/20 rule 80% of meaning derived from 20% of document content 4

5. Vilfredo Pareto Applying Pareto’s 80/20 Rule: 80 percent of the critical information/key messages comes from only 20 percent of the volume of information submitted in any individual report or set of reports Information in reports is often “noise” that can keep the reader from finding the “signal” 5

6. Agile Review Driven by extension of Pareto’s 80/20 rule 80% of meaning derived from 20% of document content Centered on satisficing document user 6

7. In CSRs and summary-level submission documents the majority of “words” are merely descriptive text that obscure meaning 7

8. In protocols the majority of “words” are merely descriptive text that obscure instruction regarding agency and actor 8

9. Apply Agile Review Method toClinical Documentation Limited time applied to the task of review Peel document like an onion (review in layers of detail) Non-linear reading of the document Involves task of skim and scan to review the document 9

10. 10 Review Focus: Architecture of the Argument

11. 11 Review Focus: Logic Trail Clarity Goal (Purpose/Hypothesis) Objectives Variables / Standards Results Conclusions (Discussion) Significance (The so what we learned )

12. Review Focus: Usability Reduce ambiguity Increase brevity Improve reader acquisition time Comprehension Recall 12

13. Review Focus: Quality of Argument Claim:The key message or conclusion drawn from the data Data:Does the document draw a red line to supporting data? Warrant: Does document define principle that justifies stated interpretation of the data to support the claim we are making? 13

14. Review Focus: Topic Sentence Review Read only the first sentence of every paragraph Confirm first sentence is topic sentence Test “flow” 14

15. Review Focus: Key Term/Word Search In a CSR Key assessment terms for primary and secondary endpoints Key safety terms 15

16. Review Focus: Summary Document Quality to Synthesize Messages/Argument What efficacy and safety information contributes to the assessment of clinical pharmacology and biopharm data? How does the PK of XXX in healthy volunteers compare to that in patients? How do PK parameters change with time following chronic dosing? What intrinsic factors influence exposure and/or response and what is impact of any difference in exposure on PD? 16

17. Review Focus: Key Term/Word Search In a Protocol Key concepts Modal verbs 17

18. Modal Verbs The word must is used to indicate mandatory requirements The word should is used to indicate that among several possibilities one is recommended The word may is used to indicate a course of action permissible within the limits of a standard The use of the word will is used when making statements of fact. The word shall is used to indicate mandatory requirements strictly to be followed in order to conform to the standard 18

19. Concept of Agile Review Agile review grew out of the pain inflicted by real-life project experiences Address the challenges and limitations of traditional document reviews—both in terms of overall philosophy as well as specific practices 19

20. Benefits of Agile Review Economy Investment of reviewer time on task Reduction of reviewers Communication quality Centered on what counts— “meaning” “usability” 20

21. “The reasonable man adapts himself to the world; the unreasonable one persists in trying to adapt the world to himself. Therefore all progress depends on the unreasonable man.”---- George Bernard Shaw 21