A framework for decision support, capture and re-use

Pharmaceutical Research and Development (R&D) is a 'knowledge intensive' business, requiring frequent and comprehensive knowledge transactions. One necessary class of knowledge transactions concerns the constant evaluation of incoming data from experiments, discussion of the data amongst scientists and physicians and the ability to make informed operational and strategic decisions amidst some uncertainty, particularly in the early phase of development. Because of these uncertainties, it is important to constantly review decisions to verify their validity as a drug development project moves on. As the decision-making is inextricably bound to appropriate risk awareness and risk management, the consideration of options and appropriate scenario planning, the application of past experience to present information should help provide a balanced assessment of risks prior to decision making. Experienced employees often immediately apply what they remember of their past experience to present problems. This past experience, together with the ability to abstract from past solutions in order to be able to apply them to new problems may be the key to robust sustainable decisions. The author's research has used a combination of pilot studies, brainstorming sessions, review meetings and surveys combined with actual working practice in an iterative manner, which has been proven useful to address the specific aims and objectives for the development, implementation and testing of a decision support framework for clinical drug development called EPISTEME. All the aims and objectives set at the outset of this research have been achieved. AstraZeneca top management has also recently used the EPISTEME decision support framework successfully to assess the impact of restructuring scenarios. This and the endorsement and adoption of the final information model and decision support framework by the AstraZeneca company, means that this research project was successful, and can now provide the basis for many further research projects on related topics at AstraZeneca and elsewhere.