Improving Data Accuracy and Reducing Delays in Clinical Trials with Lean Six Sigma
As competition and rising clinical trial costs continue to strain pharmaceutical and life sciences companies, the need to streamline processes, reduce errors, and improve quality and accuracy is greater than ever.
The Data Conundrum
Contract research organizations have adopted the use of eTMF platforms partly because they can provide faster study startup and cost savings.
However, for eTMFs to realize cost savings, the data that trial constituents enter into them must be accurate. This is a monumental challenge. A study on the data-entry errors in clinical trials showed that error rates detected by double-entry method ranged from 2.3 percent to 26.9 percent. In general, the errors were caused by faulty data entry and misinterpretation of the information in the original documents.
Per the study, the reasons for common data entry errors included the following:
- Spatial arrangement of the database fields in the data-entry forms
- Errors on one screen raise the probability of errors in data found in another field on the same screen
- Manual data entry instead of direct data transfers into a research database
- A low number of constraints on data fields
These are just a handful of examples that lead to data entry errors, and they highlight the need for the research organization to have stringent processes and procedures in place to improve inefficiencies in the execution of a clinical trial.
Leveraging the Power of Lean Six Sigma for Clinical Trials
Building better, more streamlined processes is at the core of the Lean Six Sigma methodology, and contract research organizations that adopt this methodology can expect better results because of it.
The Lean Enterprise Institute defines Lean and Six Sigma as follows:
- Lean: Lean focuses on eliminating waste along entire value streams. Lean creates processes that need less time, space, and effort to achieve set project goals at far less cost and with fewer defects. Further, Lean makes information management much simpler and more accurate.
- Six Sigma: Six Sigma uses data to eliminate defects in any process. The Six Sigma framework includes five steps: Define, measure, analyze, improve, and control (DMAIC).
A study by Elliot W. Liu published in JALA found that applying Six Sigma best practices to a phase three clinical trial data-entry process achieved significant savings in financial and human resources and significant time saved overall, with a breakthrough reduction of greater than 70 percent in cycle time and errors.
What a CRO Can Expect from Lean Six Sigma
Contract research organizations, pharmaceutical companies, and medical device companies that employ Lean Six Sigma gain the following insights:
- Clearly identifying the cause of a data entry problem, not just the symptoms
- Process-map analysis that captures the steps of the data management process
- Subprocess mapping allows for deep dives into a process by breaking it down into smaller supporting processes
- Root cause analysis to determine the fundamental reason errors are happening
- Creation of enhanced workflows
- Implement changes using a defined control plan
For contract research organizations, Lean Six Sigma can help continually achieve greater efficiency and effectiveness in phase three and four clinical trials. Need help? Contact Shearwater Health: firstname.lastname@example.org or 615-921-9510.