Costs Associated with Drug Development Grew due to Changes in Clinical Trials, According to GBI Research10 Oct 2012 • by Natalie Aster
Costs associated with drug development have risen from around $138m in 1975 to over $1 billion in 2005, with clinical trials representing a key factor in this increasing expenditure, according to a new report by healthcare industry experts GBI Research.
The new research, "Pathways to Efficient Drug Development - Advances in Modeling and Simulation Outcomes to Fuel Pipeline Productivity", looks at why researchers in the pharma industry now refer to the clinical development process as the ‘valley of death’, which must be crossed to attain drug approval.
Pathways to Efficient Drug Development - Advances in Modeling and Simulation Outcomes to Fuel Pipeline Productivity
Published: September, 2012
Price: US$ 3.500,00
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 over night, 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, Sanofi, Novartis and GlaxoSmithKline all suffering at least one setback.
Others have argued that the majority of failures in clinical trials are due to the inadequacy of animal models to predict success in humans, implying a fundamental flaw in drug development processes which use animal testing methods.
It is essential that R&D productivity is improved, and the ‘quick win, fast fail’ model is being touted as a possible way to achieve this. This model argues that investments made early in the process increase the information available on which to base key decisions, enabling the earlier termination of projects prior to huge investments being made for the Phase III program.
More information can be found in the report “Pathways to Efficient Drug Development - Advances in Modeling and Simulation Outcomes to Fuel Pipeline Productivity” by GBI Research.
To order the report or ask for sample pages contact firstname.lastname@example.org