Friday, February 26, 2010

Unnecessary Clinical Trial Data Leads to Extra Time and Cost

Oftentimes, clinical trial teams collect, clean and analyze 5 to 10 or more pages of excess clinical trial data that is never used in the final clinical trial or study reports. Moving too much data through the entire clinical trial process - including collection, data entry, data storage, querying, statistical analysis, report writing and review - leads to extensive increases in clinical trial timelines and increases the probability of data errors. Failing to narrow down the target data for clinical trials early in the study planning phase causes trials to last longer than they would otherwise have to and as well, increases the length of time to clean and quality control and quality audit the clinical trial database. Often, the number of patient visits are too numerous and too long. Thus a poor clinical trial and protocol design, will inevitably lead to more patient dropouts, erroneous data, more patient withdrawals, increased patient non-compliance and failures to follow-up. Quality control and quality audit time increases and leads to unnecessary increases in clinical trial costs, CRO, Investigator, all outsourced and otherwise, not to mention time of employees to monitor clinical trial progress, performance and status. Recent reviewed reports on this subject, estimate the time wasted on the unnecessary data collected and related activities exceeds 2-3 months when all of the additional work and rework, quality control, cleaning and quality audit are combined. As well, may seriously jeopardize the integrity of clinical trial data collected. Solution: Working with biostatisticians early in the clinical trial protocol set up, planning and design to eliminate the collection of extra, unnecessary clinical trial data. Simple. Take the team approach.

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