Clinical trials due an overhaul to conquer the Pharma "Valley of Death"

Costs associated with drug development have risen from around $138 million in 1975 to over $1 billion in 2005, with clinical trials representing a key factor in this increasing expenditure, according to a new report by health care industry experts GBI Research. The new research looks at why researchers in the pharma industry now refer to the clinical development process as the “valley of death,” which must be crossed to attain drug approval.

Clinical trials have grown longer and more complex, while volunteer enrolment and retention rates have fallen. More than 30% of experimental drugs that reach Phase III fail at this point. Late stage failures are costly to the industry - Pfizer’s torcetrapib, which failed its Phase III trial in 2006, led to the value of Pfizer dropping by $21 billion overnight, and 10,000 job losses being announced the following year.

Recent analyses show that this problem has grown in recent years. Overall, clinical approval success rates have fallen to approximately 16%, though this figure varies widely by therapeutic area. Pivotal trial and regulatory failures were recorded for 31 drugs in 2011, with Eli Lilly, Bristol-Myers Squibb, AstraZeneca, Merck & Co, Sanofi, Novartis and GlaxoSmithKline all suffering at least one setback.