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Decision-enabling studies: How robust are they?

Decision-making is an essential function of any company and determines long-term success. However, what are the key factors that influence decision-enabling in the pharmaceutical industry leading to new products and approved drugs?

To analyze the importance of Good Scientific Practice standards as well as the quality and validity of data for this decision process we have conducted an analysis of 12 drug discovery projects (preclinical up to clinical candidate selection) that were licensed over the past two years by three EU pharma companies. There were a total of 26 studies that were identified as ‘critical’ (consensus decision based on discussions with representatives of the licensee companies).

Post-licensing analysis of these ‘critical’ studies indicated that not every study was designed in a way that is consistent with its role in decision making. Only around one third of all studies were properly blinded (see figure) and only one quarter contained well-defined, pre-specified endpoints, which can significantly reduce bias and false experimental outcomes compared to post-hoc or secondary endpoint analyses.

 

 

Based on this analysis, PAASP estimates that at least 30% of early-stage innovative drug discovery projects critically depend on data that do not meet minimum quality criteria.

It is well possible that decisions to license projects are often based on factors other than the quality of research data, such as time considerations, organizational and cultural influences, subjective and personal considerations or political influences.

However, given the overall decreasing drug R&D productivity (with pre-clinical data quality as a major contributing factor), decisions during drug development as important organizational elements should not neglect the assessment of data quality and integrity. Instead, the question should be addressed whether or not GSP standards were implemented in decision-enabling studies. Structured and informed decisions will help avoiding unnecessary terminations of drugs in Phase II/III development.