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Standardize formats and procedures, where possible, to increase efficiency.
Simplify the experimental design because complex studies have the potential to yield more errors.
Plan ahead by defining the proper data set needed and specifying requirements for data quality (e.g., error rates of 1 to 5 per 1,000 for primary end-points, but 2 or even 5 errors per 100 for secondary endpoints).
Clarify expectations by discussing with regulators the types and amount of data collected, the extent of monitoring, and the methods for data analysis.
A major theme that emerged from the workshop was that of partnerships. It was proposed that industry sponsors work with FDA before a clinical trial to define a coherent set of data that will demonstrate safety and efficacy and to set up an appropriate monitoring plan to ensure the quality of those data. Although FDA has been open to such efforts and considerable progress has been made in several areas, there is room for continued improvement. Other points emerged during the workshop and are described below.
During the past 20 years the relationship between FDA and the pharmaceutical industry has evolved from an adversarial one to a more collaborative interaction. This strengthened relationship now provides an opportunity for FDA and industry to move forward on the issues of hierarchy in data quality assessment, early planning to build quality into the process, and improved communication.
Education and Training
Education of the public on the FDA review process and on the technical obstacles that industry must face when it develops even a single drug and brings it to market is important for enlisting consumer confidence. However, an even greater need is education of investigators, Institutional Review Boards, industry sponsors, and even regulators. They need to be educated that the goal is not merely passage of an inspection, but rather the generation of quality data that will support the inferences drawn from a study. There may also be a need for more specific training (and possibly credentialing) of clinical investigators, as well as clinical research associates and clinical research coordinators.
The pharmaceutical industry spends substantial amounts of money on monitoring activities not required by FDA. Consequently, industry needs to be