The future of drug development: advancing clinical trial design.

Declining pharmaceutical industry productivity is well recognized by drug developers, regulatory authorities and patient groups. A key part of the problem is that clinical studies are increasingly expensive, driven by the rising costs of conducting Phase II and III trials. It is therefore crucial to ensure that these phases of drug development are conducted more efficiently and cost-effectively, and that attrition rates are reduced. In this article, we argue that moving from the traditional clinical development approach based on sequential, distinct phases towards a more integrated view that uses adaptive design tools to increase flexibility and maximize the use of accumulated knowledge could have an important role in achieving these goals. Applications and examples of the use of these tools--such as Bayesian methodologies--in early- and late-stage drug development are discussed, as well as the advantages, challenges and barriers to their more widespread implementation.

The microeconomics of personalized medicine: today's challenge and tomorrow's promise.

'Personalized medicine' promises to increase the quality of clinical care and, in some cases, decrease health-care costs. Despite this, only a handful of diagnostic tests have made it to market, with mixed success. Historically, the challenges in this field were scientific. However, as discussed in this article, with the maturation of the '-omics' sciences, it now seems that the major barriers are increasingly related to economics. Overcoming the poor microeconomic alignment of incentives among key stakeholders is therefore crucial to catalysing the further development and adoption of personalized medicine, and we propose several actions that could help achieve this goal.

What drives success for specialty pharmaceuticals?

Specialty pharmaceuticals have become increasingly important in the global pharmaceutical landscape. Numerous large pharmaceutical companies are moving towards developing therapies for specialty markets, which are attractive owing to factors including the established commercial track record and lower commercial infrastructure costs. In this article, we analyse the key drivers of commercial success and failure for specialty pharmaceuticals.

The "new economics" of clinical quality improvement: the case of community-acquired pneumonia.

Hospitals and health systems have developed substantial infrastructure, at significant expense, to improve care quality and support the collection and distribution of quality metrics. Yet providers often have little understanding of what return, if any, they have earned on the investment because they typically view quality improvement efforts simply as a cost of doing business. After analyzing data from 10,512 patients with community-acquired pneumonia, we found that better performance on two quality measures was associated with shorter length of stay and improved financial performance. For example, a one-day decrease in the time until patients were shifted from intravenous to oral antibiotics was associated with a 0.8-day reduction in length of stay and a nearly 60 percent increase in margins. Providers can adapt the methods we used to derive these findings to identify other quality metrics that simultaneously increase care quality and generate economic value. To derive maximum clinical and financial benefit, however, providers must ensure that clinical quality staff members are adequately supported and skilled to set priorities and to implement effective initiatives.