Abstract
BackgroundPharmaceutical companies and regulatory agencies endeavor to relate their decision making with outcomes to improve future decision making and to ensure that gained knowledge is fed back into a learning system. Nevertheless, such a correlation can only be achieved by documenting the expected outcome of a decision at the time it is made, enabling comparison of the expected outcome with the actual result.MethodsParticipants at an international workshop discussed how the documentation of decisions could be evolved as companies and agencies look to improve their knowledge base. Discussions were informed by a pre-workshop survey of pharmaceutical companies and regulatory agencies.ResultsMost survey participants from 12 companies (55% response rate) and 11 agencies (73% response) have a system in place to enable documentation of major decisions, however, systems are used primarily to document outcomes rather than the process, while information from documentation is not always used, and feedback loops are not in place. The majority of participants indicated that their organization currently documents most decision-making practices included in the proposed template. Workshop participants agreed that all major past decisions should be referenceable and suggested incentives to enable decisions to be referenced, and confirmed elements and characteristics of a decision-documentation template.ConclusionsThis survey and workshop identified the current landscape and gaps in the documentation of decision making and suggested revisions for a proposed documentation template. The use of technology to enable information extraction with support from artificial intelligence and future decision making was a recommendation highlighted by participants.
Highlights
Pharmaceutical companies and regulatory agencies continually endeavor to improve their internal decision-making practices in order to ensure that quality is built into the process and to guarantee that accurate information from past decisions is available to inform current and future decisions (Fig. 1)
The outcomes, a correlation that can only be achieved by documenting the expected outcome of a decision at the time when it is made. This timely documentation enables a comparison of the expected outcome of a decision with the actual result and determines the impact without “hindsight bias”; that is, the tendency to rationalize past decision making based on current knowledge [1]
In order to provide a framework for discussions at the workshop, Centre for Innovation in Regulatory Science (CIRS) conducted a focused survey of pharmaceutical companies and regulatory agencies to
Summary
Pharmaceutical companies and regulatory agencies continually endeavor to improve their internal decision-making practices in order to ensure that quality is built into the process and to guarantee that accurate information from past decisions is available to inform current and future decisions (Fig. 1) As part of this continuous improvement process, these organizations seek to relate their decision making to the outcomes, a correlation that can only be achieved by documenting the expected outcome of a decision at the time when it is made. Pharmaceutical companies and regulatory agencies endeavor to relate their decision making with outcomes to improve future decision making and to ensure that gained knowledge is fed back into a learning system Such a correlation can only be achieved by documenting the expected outcome of a decision at the time it is made, enabling comparison of the expected outcome with the actual result. The use of technology to enable information extraction with support from artificial intelligence and future decision making was a recommendation highlighted by participants
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