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.

Modern piller of Clinical Trial Industry

                                  Modern Piller of Clinical Trial Industry
Compulsion of Jurisprudence:
Till now there was no act or law to monitor clinical research and drug trials in the country and “Jurisprudence” is the necessity to ensure that people who undergo clinical trials are not exploited and informed about the protocol. It was needed to enhance capacity building handle trial in more scientific and rational way. Awareness amongst patients is certainly increasing. 2012 to 2014 has been crucial for the clinical trial industry as an uncertain regulatory environment, however in recent months clinical trials has been found to be new momentum. Supreme Court laid down various principles of risk versus benefit to patients, need for innovation (existing therapeutic option), and the unmet medical needs in the country. These are the standards but to satisfying these standards there are lots of remains to be done. These standards give force to the clinical trial industry in India. The government is aware and has been making serious efforts to accomplish the same. New enactment of law will bring more professionalism. 


Testimonial and Ethics:
Negative coverage in the media brought bad name to research, certainly there were the reasons to downturn the economic but the media attention over the last couple of years has also played a major role too and guinea pigs word is the vilify and invention of media. Food adulteration in India is common so the common men are called Guinea Pigs? 
Clinical research cannot stop in the country and then why not accreditation? On the other hand if you think of accreditation and ethics i.e. clinical trials in India to be put on firm foundation a structured accreditation process, accrediting investigators, trial sites and ethics committee, making ethics committee function effectively and concerning informed consent from trial subjects. Accreditation will become centerpiece of clinical trial industry. Accreditation does not only mean to registration but the developing such standard operating procedures, conflict of interest is the highlighted question for the ethics committee. And for that ethics committee members need to go under training and then it gears towards safe and effective trials where all ethical norms are followed.


And now the accreditation is the key positive spin off to prevent the conflict of interest such as malpractice, unscrupulous decisions in clinical trials. A key offset of accreditation would be a strict adherence to finding independent persons to serve on ethics committee, and these could be achieved by randomized allocation of experts to particular ethics committee together with a supplementary check by accrediting body. Now we can imagine independence of the ethics committee and change the viewpoint of trial subjects too.

Welcome move:
CDSCO issued draft guidelines this year on audio visual recording of informed consent process in clinical trial. It is mandatory to take audio visual recording and safe storage for taking of informed consent from trial subjects.


But the question stands for the privacy of patients who might not wish to be recorded however it is recommended such recording should be mandatory subject only to waiver by the trial patient or ethics committee. The industry is taking very as difficult task, and in present scenario where video recording are possible with smart phones and the second matter is confidentiality of the patients would be lost however it can only take as excuses, maximum numbers of patients don’t hide themselves while undergoing trials. Why the industry is not accepting the change and ready to compromise in Ethics very easily? 


Stand-alone set of rules governing clinical trials promotes transparency. CDSCO proposed changes and brought together under consolidated umbrella of rules governing clinical trials. Nobody blames the US FDA because its decisions on science and Indian government tried to bring out based on science. And this is going to give you necessary certainty to undertake trials in India. And the later on benefits for India if you take for the development of new drugs, employment generation in clinical trial industry and would be safe environment for every citizen desirous of participating in clinical trials and that would be tremendous. With the growing number of diseases around the world, there is always need of well-structured policy which helps in saving life and will give impetus to grow medical and Para medical industry.