The Clinical Trial Protocol

Writing a protocol is easy isn’t it? Well it is until you come to write it and then come the questions... Why are we doing this? What’s the background? Who are the stakeholders? Why is the study needed? What shall we measure? How will we analyse the data and present it in the report? How many patients? Then you think where do I start? Don’t worry help is at hand in this monograph. It covers in a common sense practical way how to go about writing a good protocol. It explains how to get the background knowledge, how make the main scientific decisions such as choice of design, endpoints, comparators, patient numbers, statistical analyses etc and all the practical details such as ethical aspects and logistics. This monograph is a ‘must’ for everyone involved in clinical research that uses a protocol whether they are writing, critiquing or reviewing it for feasibility.

Please note: Printing of the book is limited to 2 pages. Copying and pasting of the book is prohibited.

Nyckelord: trial protocol, clinical research, legislation