Clinical Trials Monthly Case Study Analysis


Each month, we take a look at a different Clinical Trial Case Study ? this month it?s a look inside an ALLERGY trial that focused on EXCEPTIONAL RESULTS:

The Scenario: Criterium provided an IVR patient diary solution to collect the pivotal efficacy data for an international clinical trial.

We asked ourselves😕 What if an after-the-fact paper patient diary could have been disastrous and could have necessitated the client repeating the study?

????????????? Because the estimated patient compliance rate was critical for the statistical analysis, Criterium daily monitored the patient diaries.

????????????? Through StudyControl?, Criterium designed reports to evaluate the compliance of each patient during the study. When patient compliance was less than predicted, Criterium informed the client immediately. This critical intervention enabled the sponsor to enroll additional patients into the study.

Additionally, daily management of the site by Criterium?s knowledgeable staff members helped ensure that patient compliance among the additional study participants was at the highest level, thereby meeting the study?s control requirements.

Our Result: The statistical analysis exceeded the client?s expectations.

Creative thinking in designing clinical trials upfront is always the ideal, but it?s important to remember that there are factors and variables that can?t be accounted for during planning.? When we look at trials, we look at all the factors that surround the potential issues facing a trial ? technology can be a great tool to keep trials running smooth, but it’s the human factor that allows the technology to be a reliable component of the work.

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Claire WyntersThu, 14 Mar 2013 16:21:00 GMT

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