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

New book reveals Charles's seven egg habit

Maev 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?

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.

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.

None of us are Prince Charles

Scottish Medicines Consortium

 Guidance to Manufacturers for completion of

New Product Assessment Form (NPAF)

How hard-boiled do we need to be?

How to make a good clinical submission to SMC

Bigendians vs Littlendians

Summary

• No more than one page.

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.

Pivotal studies

• Recent

• Relevant comparator

• Robust

• Powered

• Placebo-controlled– Only if data from comparative trials are not available.

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.

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.

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.

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.

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

Bigendians Littlendiansvs

War and peace

A slim volume of short stories

Reference 5416:

That thing Joe had published in some journal.

Appendix 541:

Middlendians

Scottish Medicines Consortium

 Guidance to Manufacturers for completion of

New Product Assessment Form (NPAF)