Six Sigma Quality Improvements in Clinical Trials - Essay Example

Six Sigma Quality Improvements in Clinical Trials The aspect Six Sigma refers to a statistical term that concentrates on establishing and delivering near-ideal products, results, or services in a consistent manner (Schweikhart and Dembe 748). As such, the Six Sigma strategy seeks to improve the quality and efficiency of diverse operational processes (Schweikhart and Dembe 748). In this context, Six Sigma seeks to play a significant role in improving the quality and efficiency of diverse clinical trials. Indeed, the Six Sigma strategy focuses on making different processes more homogenous and specific via the structured adoption of statistical methods (Schweikhart and Dembe 748). The Six Sigma refers to a quality level that is prone to minimal operational or experimental errors. In statistical analysis, Six Sigma represents standard deviation that indicates the level of variation in an experiment or operation (Pokharkar et al. 1160). The highly disciplined strategy entails three elements that include process improvement, re-design, and process management (Pokharkar et al. 1161). The Six Sigma strategy was initially dominant in the manufacturing industry where it played a noble role in meeting the client’s needs based on the DMAIC method (Snee 4). However, other industries including the health care industry have since adopted the six-sigma strategy to address the heightened competitive market pressures (Pokharkar et al. 1160-1163). Indeed, Lean and Six Sigma strategies have been fundamental in clinical and translational research where they enhance various processes. The strategy can achieve this by eliminating delays and errors, enhancing quality, and facilitating the timely adoption of biomedical discoveries. The NIH Roadmap for Biomedical Research and the NIH Clinical and Translational Science Award program recognize the potential of the six-sigma quality improvements in clinical trials (Schweikhart and Dembe 748). Various scholars establish that Lean and Six Sigma relate and try to improve total quality management by deriving a more discrete and measurable operation. The strategy also quantifies results and aims at delivering certain quality improvements within a given period. Clinical trials rely on six-sigma quality improvements to concentrate on process management, adopt standardized method for monitoring process improvement, and making sure that the trials address the clients’ needs. In most cases, the six sigma strategy works together with the lean strategy, which aims at improving delivery time, reducing operation costs, minimizing cycle times, and eliminating waste products. As such, a Lean Six Sigma guarantees speedy and consistent clinical trials (Pope 1). Indeed, the Six Sigma quality improvements led to the development of the Lean Six Sigma methodology that is equally applicable in clinical trials. The six-sigma strategy has immense potential in data management and cost reduction in clinical trials. This emanated from the need to stabilize the ever complicated and costly clinical trials conducted by Pharmaceutical and biotech industries (Snee 3). The inefficiencies manifested in clinical trials processes increase the costs of clinical trials since they cause delays and many experimental errors. Indeed, the clinical trials are prone to varied performance processes, human errors, incomprehensive processes, experimental gaps, heterogeneous activities, and varied data updates and reviews (Snee 3). Various studies confirm that adopting DMAIC (Define, Measure, Analyze, Improve, and Control) can help in solving varied problems and processes involved in clinical trials (Pokharkar et al. 1162). The Six Sigma is a potential strategy to address various issues in clinical trials since the Six Sigma quality improvements can establish flawless operational processes. As a result, many organizations involved in health care research have experienced the DMAIC framework by applying the Six Sigma and Lean methodology in their operations with an aim of eliminating data errors and delays (Pope 1). Ideally, clinical trial participants like sponsors, CROs, and IRBs have the capacity to solve delays and data collection errors as well as enhance delivery time and overall accuracy of clinical trials by adopting the Six Sigma strategy (Pope 50). Worth noting is the fact that turnaround time and data accuracy are fundamental in clinical trials and hence the need for all participants of clinical trials to focus on improving efficiency and accuracy for purposes of doing things right in the first attempt (Pope 50). The participants can achieve this by adopting the Six Sigma strategy and focusing on unearthing the real causes of delays and errors in clinical trials. The Six Sigma vein drives decisions based on clinical data thus defining the root of problems in clinical trials (Pope 50). Ideally, the holistic adoption of the Six Sigma strategy will guarantee maximum returns, consistency, and a continuity of the clinical trials. Upon proper deployment, Lean Six Sigma methodology is evidently suitable for different clinical trials. The methodology allows clinical trials participants to get it right in the initial attempt by minimizing study times and error levels during trials. A study on how to improve laboratory data entry established that the Six Sigma Quality Improvement (QI) project team relied on structured clinical steps that entailed describing the project objectives, establishing data entry errors to analyze current performance, and analyzing data and determining data-entry error root causes (Elbireer, Chasseur, and Jackson 496-498). Subsequently, the Six Sigma Quality Improvement (QI) project team adopted the changes and control measures with an aim of addressing the causes and maintaining improved laboratory data entry (Elbireer, Chasseur, and Jackson 501-503). Notably, developing the Six Sigma project requires immense resources and the maintenance of the strategy requires more time and resources (Elbireer, Chasseur, and Jackson 496). Apparently, the Six Sigma initiative led to reduced data entry errors during the experimental period thus confirming the merits of the strategy. The Six Sigma QI project offers a paramount platform for laboratory staff and other clinical participants to enhance a quality clinical environment. The strategy allows clinical staff to offer quality healthcare at reduced cost through Six Sigma Quality Improvement. The Six Sigma Quality Improvement reduces data entry errors in clinical trials, improves the clinical workflow processes, and save costs in the entire health sector (Elbireer, Chasseur, and Jackson 502). The six sigma works because it involves the senior medical personnel, uses sound statistics, and focuses on trials and the target population. The Six Sigma supports clinical operations that relate to the people that may include healthcare givers, patients, health agencies, and CRAs. Apparently, the Lean and Six Sigma strategy enable the achievement of NIH’s objective of establishing a more efficient, quality, and cost-effective clinical trials as seen in biomedical research findings. Works Cited Elbireer, Ali, Julie Le Chasseur, and Brooks Jackson. "Improving Laboratory Data Entry Quality using Six Sigma." International journal of health care quality assurance 26.6 (2013): 496-509. Pokharkar, Deepak, Varsha Jadhav, Sachin Gholve and Vilasrao Kadam. “Six Sigma: Golden Opportunity for Pharmaceutical Industry.” International Journal of PharmTech Research 2.2 (2010): 1160-1164. Print. Pope, Dawn. "Do it Right...the First Time." Applied Clinical Trials 22.3 (2013): 50. Pope, Dawn. “Lean Six Sigma in the Clinical Trial Industry: Two Perspectives.” Applied Clinical Trials, Oct 09, 2012. Web. 17 April 2015. < http://www.appliedclinicaltrialsonline.com/lean-six-sigma-clinical-trial-industry-two-perspectives> Schweikhart, Sharon A, and Allard E Dembe. The Applicability of Lean and Six Sigma Techniques to Clinical and Translational Research. Journal Of Investigative Medicine 57. 7 (2010): 748–755. Snee, Ronald D. “Achieving More Efficient and Effective Clinical Trials How to create and sustain improvements in critical work processes.” Tunnel Consulting. Web. 17 April 2015. Read More