Friday, October 1, 2010
Patient Recruitment- Clinical Trials
The first step is to define exactly what is meant by patient recruitment. This is not as straightforward as it sounds. There are several steps from the patient being identified and contacted to starting the study treatment. These include screening the patient, obtaining informed consent. randomising the patient, a possible baseline assessment and then initiation of treatment. Exactly when the patient is said to be enrolled in the trial should be
defined in the protocol.The recruitment period, i.e. starting and finishing date of recruitment for the entire study, may also be defined in the protocol.
Intention to Enrol list:For the purpose of this SOP, an ‘Intention to Enroli st’ is a record of all patients who were considered, were eligible for the study, but who, for one reason or another, were not included. This list enables a comparison of the potential patient population with the patient population actually enrolled in the study. It is helpful when questions of bias arise during evaluation of the data.
defined in the protocol.The recruitment period, i.e. starting and finishing date of recruitment for the entire study, may also be defined in the protocol.
Intention to Enrol list:For the purpose of this SOP, an ‘Intention to Enroli st’ is a record of all patients who were considered, were eligible for the study, but who, for one reason or another, were not included. This list enables a comparison of the potential patient population with the patient population actually enrolled in the study. It is helpful when questions of bias arise during evaluation of the data.
Nice blog. Patient recruitment and retention in clinical trials is wide recognized as the leading bottleneck in the new drug development pipeline. Thanks...
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