Why is publication of negative clinical trial data important?

Abstract

The pharmaceutical industry is facing troubled times, both in the UK and globally. Revenues are being hit by patent expiries on blockbuster drugs like atorvastatin, salmeterol xinafoate/fluticasone propionate and olanzapine; and development pipelines are insufficiently robust to replace these lost revenues. Drug discovery productivity has failed to improve over the last 15 years, despite the large sums of money that have been spent on research and development (RD Pangalos et al., 2007) although phase III failure rates in CNS are lower than those in oncology (Arrowsmith, 2011a). This has resulted in several large companies scaling down their research operations (GlaxoSmithKline in the UK and Verona, Merck in the UK, Pfizer in the UK at Sandwich, Novartis in Switzerland and AstraZeneca at Loughborough in the UK) in an effort to reduce costs and refocus research on areas seen to be less risky. Such closures can have a direct effect on the regional economy in these areas and also an impact on national academic research as there are fewer opportunities for collaboration and for leveraging industry funding. Various solutions have been implemented with a view to improving productivity: research operations are being split into smaller units in an effort to recapitulate the innovative culture of the small biotechnology companies, such as the GSK CEDDs (Centres of Excellence for Drug Discovery) and DPUs (Discovery Performance Units) and Pfizer's NewMeds business units; pipelines are being replenished from small and larger biotechnology companies through a range of different deal types; and contract research is being sourced in Asia where costs are currently lower. However, there is no clear indication that such changes will increase the probability of success, although they may reduce the cost of failure. Clearly, methods of reducing attrition should be pursued at all points along the drug discovery and development process. However, the impact of reducing failure in clinical trials should be greater than reducing failure in the discovery phase, as this is where the most spend occurs.