Practicing What We Preach: The Application of Continuous Improvement in a Preclinical Statistics Department at a Pharmaceutical Company

V. Bill Pikounis, Joseph M. Antonello, Danielle Moore, Edith T. Senderak and Keith A. Soper

Abstract:
The Biometrics Research Department at Merck Research Labs supports preclinical and „nonclinical phases of drug research and development. Our clients expect us to provide written reports that fully document our statistical evaluations of their data. Studies include toxicity, efficacy, and validation of vaccines and pharmaceuticals. While our primary clients are scientists, the needs of regulatory affairs and quality assurance personnel are also frequently prominent. Principles of Total Quality have been practiced in collecting data for accurate evaluation of the effectiveness of our written reports, and in the implementation of improvements. For the sample of scientists (N=24) surveyed, formal statistical analysis revealed an’improvement in clarity at follow-up (P=0.008), even though baseline results for report clarity averaged at or slightly above expectation. Scientists also reported improvement in communications as part of overall service (P=0.003). Response time for producing written reports essentially remained the same, and clients now have raised expectations for timeliness in that regard. The concern for turnaround time points to a closing discussion of long-term prospects for permanent integration of a continuous improvement philosophy into the department.

Keywords:
Total quality; Merck; written reports.