Recruitment and Retention

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Dear friends

I have already discussed regarding importance of recruitment and retention of participants in clinical trials.

As you know the timeline of trials is so stringent that recruitment need to be made faster in order to complete the trial on time. In some cases it is very difficult to meet the recruitment target due to

delay in initiation of clinical trial

delay in screening

withdrawal of participant

increased drop out rate

immature termination of trial

major protocol violation

stringent inclusion/exclusion criteria

Here i would like to add my experience, i was working as CRC in one of the Phase-III clinical trial of septic shock. The inclusion criteria was so stringent that we were not able to fulfill the initial requirements for enrollment of the participants. Majority of the patients did not fit into study inclusion criteria and few patients who met criteria refused to sign informed consent.

You can understand that taking informed consent in such a critical situation is really challenging. In those situations where participant cannot sign informed consent due to severe illness, we need to take informed consent from Legally acceptable guardian (LAR) or impartial witness.

In some situations, we need to redesign the inclusion/exclusion criteria as per feasibility but after formal permission from National regulatory authority by sponsor or IEC.

Thanks and Regards

Tarun Wadhwa

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