Patching Up Europe's Data Deficiencies

"The robustness, rigor and validity of research data can be problematic," concedes the Innovative Medicines Initiative, Europe's $6 billion drug research program run by the European Commission and the European pharmaceutical industry grouping, EFPIA.    It's a pretty damning admission from an organization dedicated to research. It recognizes the concern that the failings engender among agencies funding research, as well as the impact on conclusions about the predictability of preclinical models, or the quality of drug targets for evaluation in clinical proof-of-concept studies. "Higher failure rates due to non-reliable scientific data increase the risks and costs associated with R&D and hamper the successful translation of innovation into novel treatments for patients," it concludes morosely.   At least IMI's latest offer of funding aims to remedy the deficiency, or at least to make a start.   A $160 million tranche of grants that IMI advertised in late April devotes $13 million to projects to boost data quality in preclinical research and development, on the grounds that "for drug development, robust data and scientific rigor are key drivers for decision making, determining patent strength, time-to-market and consequently availability of new treatments to patients." These issues concern all areas of R&D, it adds, and "hamper progression through the drug development pipeline for industry and academics that want to engage in drug development."   So it is inviting bids to run a pilot that will study the situation in neuroscience, where a large amount of data is available both from the public and the private sectors and the impact would be very high. The successful bidders will also have to run a comparison with preclinical safety pharmacology, with the task of identifying the key factors affecting data quality and developing some solutions.   The emphasis is on public-private collaboration involving industry and academia, partly because this is in some respects IMI's stock-in-trade (it is after all the biggest public-private partnership in the world in drug development), and partly because it believes this is a good way to tackle the many factors that can have a negative impact on quality.   While some of these factors are merely technical or methodological, many of them are also cultural (IMI highlights publication pressure, funding requirements and biased reporting) or educational (including issues with the experimental design and quality expectations). IMI also points to differences in how researchers in distinct organizations handle data quality, "consequently hampering successful innovation and rapid R&D progress." A joint collaborative effort can also help take account of different perspectives – and is all the more important in light of the increasing externalization of research activities by the pharmaceutical industry and the rise in industry-academic collaborations, it argues in its invitation to bidders. In addition, working together on solutions is, it suggests, the best way to ensure any recommendations for improvement win wide acceptance.   The out-turn from the selected project should be sufficient evidence and data to make possible the development of quality criteria for new or improved preclinical tests. Based on those data, quality management recommendations for non-regulated R&D should be developed to enhance the quality of decisions made based on experimental, explorative or hypothesis-testing data. Developing an educational course on data quality could also be expected to strengthen the quality culture in preclinical research.   Because this is IMI, and IMI is half-run (it likes to say "jointly run") by industry, there is already a clutch of drug firms attached to the project: Janssen will take the lead, supported  by Abbvie, Boehringer-Ingelheim, Novartis, Orion, Pfizer, Psychogenics, Roche, Servier and UCB. The project is expected to run for 36 months. Anyone wanting to get involved has until July 26 to submit a proposal. Details at