Introduction to Clinical Trials
UKCCSG Protocols – development and approval process
For UKCCSG protocols there is a two stage process for approval. The day to day development of the protocol will be led by the identified Chief Investigator, in collaboration with colleagues from other disciplines within the particular Tumour Working Group.
Once the clinical ideas have been formulated to a reasonable degree, a ‘concept’ will be produced, using a standard template. The concept contains the basic ideas behind the proposed study, including statistical information to demonstrate that the study is viable, in terms of available patient numbers and statistical power to answer the study questions.
Once the concept has been approved at a national UKCCSG meeting, the Chief Investigator will be required to develop a draft protocol for final approval. Once that final draft has been approved, the protocol is finalised and submitted for ethical approval.
Throughout the protocol development process a number of Data Centre personnel will be involved (Trial Coordinator and Statistician, and Executive Director).
The approval process by UKCCSG involves consideration at one of the two national meetings a year. Prior to discussion at the national meeting, the concept or final draft is circulated to centres for discussion and feedback of comments. The result of that feedback is then disseminated as part of the approval discussions.
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