Lean and Six Sigma techniques in Clinical Trials

Process improvement techniques increasingly have been applied outside manufacturing for examples software development and healthcare. I Concerns the potential use of lean and six sigma to improve the process involved in clinical research. Improving quality, avoiding delays and errors and speeding up the time to implementation of biomedical discoveries is primary objective. Reducing the time between biomedical research discoveries and their adoption into clinical practice requires increased co-ordination, systematic planning.

Better co-ordination, timeliness, efficiency and value of clinical research can be achieved by applying the set of principles, practices and method represented by Lean and Six sigma.

Lean thinking involves a set of principles, practices and methods or designing, improving and managing process. Lean process reflects the goal of continually reducing waste and improving work flow to efficiently produce a product or service that is received to be or high value. Lean assessment include “Value stream mapping” which is root for identifying opportunities to reduce waste & more highly integrate process, steps. Thus improving process efficiency. Lean focus on identifying ways to streamline process and reduce waste.

Six Sigma more live business management strategy used to improve the quality and efficiency of operational Process. Six Sigma focus on to make process more uniform and precise through application or statistical methods.

Examples of Lean strategies to the clinical research
•Research grant funding Protocol approval
•Biostatical consultation subject recruitment
•Availability of pilot data
•Informed consent form
•Minimize protocol amendment – Placebo really needed
•Strict subject monitoring consider database recruitment.

Examples of six sigma strategies into clinical research
•Select best endpoints – have qualified research team
•Treatment scheduling- statistical analysis of defects
•Inadequate enrollment
•Reasons for Protocol deviations
•Address of conflict of interest

Analysis start with determining sponsor needs, systematically evaluate each process step in detail and then identifying sources of inefficiency and waste, while also assessing organizational structure, culture and management. Analysis can be determined by on site observation and acquisition of process data for example relating to patient load, nurse staffing needs and protocol requirement. After repeated improvement cycles and field testing incorporates into computer assisted scheduling system. Training and support procedures should be develop to assure staff understands how to use the new system and to address any concerns they might have with the revised process.

These combined approach assert that organizations can benefit from utilizing both the customer orientation and focus on eliminating waste inherent in lean along with statistical tools and systematic defect reduction strategies referred in six sigma.

Approaches are proven the tools are Powerful, DMAIC guided problem solving methodology has improved business process and work process across industry including life sciences where it is now being applied in every stage of drug development and commercialization. It provides rigorous data driven techniques which reduce process variation, identity and eliminate root cause of problems and ensure improvement endure.