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Randomization, blinding and drug supply in interactive voice response trials.
The talk is presented by Damien McEntegart based on
his experience of managing 1500 such trials.
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In the talk, I'll be covering the question of what are
interactive voice response trials which I will refer to as IVR trials.
I will also cover the web equivalent which I term
interactive web response trials or IWR for short.
I'll provide an overview of randomization and supply dispensing in
traditional trials and also in trials managed electronically by IVR/IWR.
I will detail the use of static randomization methods using IVR/IWR.
Similarly, I will discuss the use of
dynamic randomization procedures which have recently been the source of some controversy.
Finally, I will outline blinding and selection bias considerations in IVR/IWR trials.
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What are IVR and IWR systems?
In IVR trials, the user,
who might be an investigator, monitor,
or study team leader,
uses the telephone keypad to enter
information and then receive voice response instructions.
In IWR trials, the user enters data via the web and then receives online instructions.
Behind-the-scenes,
for both IVR and IWR central databases are used to store all important information.
So, that a full audit trail is maintained.
For an industry trial,
system is required to be compliant with
the FDA 21 CRF 11 guidance which covers the security,
validation, and training standards for electronic systems in clinical trials.
The system needs to be available for use 24 hours a day, seven days a week.
Use of IVR and IWR systems is very common in late phase two and phase three trials.
The needed class recruitment is done by conducting multinational studies.
Till date, I estimate that over 10000 trials have been managed using the methodology.
