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T-14: Quality Management Using Six Sigma Tools For Clinical Research Sites

Poster Presenter

Toshiko Ishibashi

Oncology Medical Science Department, Medical Affairs Division
Daiichi Sankyo Co., Ltd.
Japan

Objectives

The capacity of risk assessment varies among CRCs, and the actual CRC activities also vary. To ensure a constant level of quality which does not vary among individual CRCs, some methods of Six Sigma was adopted for CRC activities at a certain clinical research site to assess its usefulness.

Method

Six Sigma’s a technique, the steps for stabilization, DMAIC Methodology were adopted to improve the process of clinical trial data systematically. The scheme was mainly performed by the person in charge of improvement and all the CRCs at a certain clinical research site.

Results

The result of applying the Six Sigma methodology, the following effects were achieved at the clinical research.1) Missing data and deviation from protocol that had been seen before did not occur. 2) All the missing data and potentially missing data were reported to, and shared by all members. 3) Through the efforts discussed above, the minimum framework was formed so as not to rely on the experience and skills of individual CRCs. Though the number of clinical trials increased 10%, we were able to reduce the number of protocol deviations to 38% in a year, compared to the same period from the previous year. The characteristics of the six-sigma activities carried out in the clinical research site, and related issues It is difficult in terms of time and money for us to assign black-belt staff dedicated to six-sigma work, or to leave tasks such as training green-belts to other people. In a clinical research site (medical workplace), there are many things which require immediate kaizen (things which may lead to medical errors), rather than kaizen as part of a long-term project -> Problems must be removed in a timely manner, or the work is meaningless. At medical institutions, it is difficult to make time where everyone can meet and have discussions. In the medical workplace, people doing work are always busy and in a hurry. ->Keep the time which staff members are obliged to spend as short as possible. Good ideas for carrying out six-sigma plans in the medical workplace use a period of about 30 minutes before morning outpatient visits start. Do the work in a place where staff members have their own desks. So that matters can be considered in a short time, decide on elements of problems in advance, and leave staff members to do preparation such as drawing process maps in their own spare time. ->They have to use a method which places only a light burden on staff and allows small details of problems to be dealt with, otherwise the initiative will not last long.

Conclusion

Through the efforts discussed above, the minimum framework was formed so as not to rely on the experience and skills of individual CRCs. Through discussions of the processes above by all CRCs, less-experienced CRCs were able to learn skills of experienced CRCs, resulting in high educational effect and better communication in the organization.