Protocol deviations: did the trial go according to plan?

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  • What does it mean?

Protocols are plans that set out how a trial will be delivered. However, unexpected events may happen, or mistakes can be made which lead to what is called a "protocol deviation".

In our toothbrush trial, imagine that by mistake a patient allocated to toothpaste A is given toothpaste B. Or that we should only include patients that have no history of toothache, but a patient fails to recall this until after entering the trial. Those can be considered protocol deviations.

  • An example
Emma joined the toothpaste trial and was randomised to receive toothpaste A. Emma takes her toothpaste prescription to the pharmacy and takes her toothpaste A home. However, Emma lives with Jess and they usually share their toothpaste. A few times Emma, by mistake, uses Jess toothpaste. When she realises this, she reports it to the trial team. The trial team decide this is a protocol deviation.
  • How can patients get involved?
Patients can be involved, along with the research team, in defining what should count as a protocol deviation. This definition will have to follow certain rules related to treatment's risks and available regulation, but there is room for discussion. Patients can also be involved in what is reported in the trial's final report and how. 


Comments

  1. Unknown11 March 2022 at 07:45

    Patients can also be involved in discussions to aid learning about how protocol deviation's have happened - e.g. did the participant info make it clear to Emma, in an accessible way, that she should be careful to only use toothpaste A.

    ReplyDelete

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