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New book reveals Charles's seven egg habit Maev Kennedy Saturday September 23, 2006 The Guardian

New book reveals Charles's seven egg habit Maev Kennedy Saturday September 23, 2006 The Guardian. With power comes the obligation to reach agonising decisions: completely runny, just set, soft-boiled or as hard-boiled as the rock of ages?.

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New book reveals Charles's seven egg habit Maev Kennedy Saturday September 23, 2006 The Guardian

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  1. New book reveals Charles's seven egg habitMaev KennedySaturday September 23, 2006The Guardian With power comes the obligation to reach agonising decisions: completely runny, just set, soft-boiled or as hard-boiled as the rock of ages?

  2. Faced with the terrifying responsibility of second-guessing Prince Charles, on such an excruciatingly personal matter, it seems his staff chose to play safe and cover all options.

  3. A series of eggs was cooked, and laid out in an ascending row of numbers. If the prince felt that number five was too runny, he could knock the top off number six or seven.

  4. None of us are Prince Charles

  5. Section 1: General guidance for completion Section 2: Economic guidance for completion Scottish Medicines Consortium Guidance to Manufacturers for completion of New Product Assessment Form (NPAF)

  6. How hard-boiled do we need to be?

  7. How to make a good clinical submission to SMC Bigendians vs Littlendians

  8. Summary • No more than one page.

  9. Comparative safety and efficacy • Details of randomised controlled trials, meta-analysis or other studies. • From full published reports and/or clinical study reports. • Core evidence NOT from abstracts or posters unless they provide additional details. • From regulatory documents e.g. EPAR.

  10. Pivotal studies • Recent • Relevant comparator • Robust • Powered • Placebo-controlled • Only if data from comparative trials are not available.

  11. Reported in appropriate detail • It is not sufficient to state that there is a description of the study in an accompanying document or appendix. • Revised guidance (under consultation) gives more specific advice on the level of detail required.

  12. Fully referenced and all references provided • Each point in the submission should be referenced clearly to the source document. • References should be Vancouver style and a clear list of references should be provided. • All references (paper or electronic) should accompany the submission, including data on file. • Avoid ‘padding out’ the submission with papers which are not directly relevant to the submission.

  13. Clinical effectiveness • Help us understand how any benefits shown in trials will translate to patients in routine clinical practice in Scotland. • NOT a ‘cut and paste’ from the Comparative Efficacy and Safety sections.

  14. Clinical effectiveness • a)limitations of the trial methodology and conduct. • b) relevance of the outcomes assessed in clinical trials to clinical benefits and adverse effects expected in practice. • c) factors which may influence the applicability of study results to patients in routine clinical practice in Scotland.

  15. Clinical effectiveness d) balanced account of the advantages and disadvantages of this in the indication under review relative to existing therapy: • Alternative treatments • Relevant guidelines etc • How data from direct comparisons shows direct benefits • Indirect comparisons should only be used where direct comparison is lacking • In this section, provide details of the methodology conduct of any indirect comparisons described in the clinical or economic sections

  16. Bigendians Littlendians vs

  17. War and peace A slim volume of short stories

  18. Reference 5416: That thing Joe had published in some journal.

  19. Appendix 541:

  20. Middlendians

  21. Section 1: General guidance for completion Section 2: Economic guidance for completion Scottish Medicines Consortium Guidance to Manufacturers for completion of New Product Assessment Form (NPAF)

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