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| home > epc > winter 2001 > integrative protocol design considerations employing interactive voice response system (ivrs) technology |
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European Pharmaceutical Contractor
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In the advent of information technologies being applied to clinical trial development, technological advances in interactive voice response systems (IVRS) have led to the efficient management of multiple facets of clinical trial research. The implementation of IVRS technology has enabled pharmaceutical and biotechnology companies to expedite clinical trial development on a global scale through advanced randomisation schemes, real-time enrollment data, and efficient clinical drug supply management. As industry continues to aspire to rapid drug and biological device development, integrative protocol design will be essential in the effective competition within the global pharmaceutical and biotechnology industry.
During the protocol design period, a number of key strategic decisions are required by a number of experts to achieve a common goal of efficacy, safety, and tolerability of the investigational drug or device. Some of these decisions include the following:
Determination of primary and secondary objectives for statistical analysis
Enrollment requirements to achieve statistical power in analysing primary
and secondary objectives
Identifying inclusion/exclusion criteria to ensure subject safety and support
efficacy assessment
Outlining a subject visit schedule to collect clinical data to show safety,
tolerability, compliance, and efficacy
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