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Background Under Good Clinical Practice guidelines, patients have the right to withdraw from a trial at any time, for any reason. However, definitions of withdrawal vary from patients ceasing all trial specific activities to stopping the assigned intervention while continuing with follow up. Early withdrawal with no further follow up is problematic and leads to missing data and research waste. Health Research Authority guidance states that Patient Information Sheets (PIS) should clearly inform patients what is expected with regards to subsequent follow up and the use of existing data if they withdraw.

A review of the description of patient withdrawal in trial protocols and patient information sheets (PIS)