Clinical Trials

OPDIVO: The High Stakes of Comparative Efficacy

The Wall Street Journal recently reported that Bristol-Myers Squibb stock dropped dramatically on August 5th, 2016. This occurred after clinical trial results indicated that BMS’s immunotherapy drug OPDIVO® (nivolumab) failed to demonstrate a clinical improvement compared to chemotherapy in patients with newly-diagnosed lung cancer.

The financial market reaction to the clinical trial results highlights the growing importance of comparative efficacy research, both for obtaining approval and market access and, increasingly, for remaining competitive and driving profits. The impact of this announcement shows that the stakes are higher than just obtaining regulatory approval. Clinical trial results can have immediate and significant consequences before any regulatory decisions are even made. Here we discuss the importance of comparative efficacy research on market access, pricing, profitability, and competition.

Overcoming the Market Access Hurdle through Better Planning of Clinical Trials

The breadth of clinical trial data applicability is expanding, informing an increasing number of decisions along the path to market access. In the past, results from clinical trials were used for one goal: regulatory approval. With regulatory approval came assurance that the drug was deemed safe and efficacious by the governing bodies (FDA, EMA). This approval paved the way for a new market entrant and the concomitant sales and marketing efforts to drive adoption.

The Potential Cost and Implications of Transparency Without Context in Clinical Trial Data

Data transparency continues to be a topic of interest that has been generating a lot of news lately. The European Federation of Pharmaceutical Industries (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have recently pledged to help make clinical trial data more readily available to researchers. Earlier this year, the European Medicines Agency (EMA) proposed a policy that placed fewer restrictions on who can access the data. The idea behind increasing data transparency is admirable, with its promise of making more useful information available to more people. However, increasing transparency without context can have unintended consequences.