A Call To Rein In Phase III Trials

Here's a very nice perspective on what gets funded in drug research and why. Robert Kocher and Bryan Roberts bring their venture-capital viewpoint (Venrock) to the readers of the NEJM: It is not mysterious why projects get funded. As venture-capital investors, we evaluate projects along four primary dimensions: development costs, selling costs, differentiation of the drug relative to current treatments, and incidence and prevalence of the targeted disease (see table). For a project to be attractive, it needs to be favorably reviewed on at least two of these dimensions. Many drugs designed for orphan diseases and cancers are good investments of scarce capital, since they tend to have relatively low development costs and selling costs and to be strongly differentiated from the current treatment options. Conversely, investors are less likely to fund drugs with much higher development and selling costs (e.g., drugs for type 2 diabetes or psychiatric disorders) and drugs that cannot be strongly differentiated from current treatment options — often because low-cost generics are available to treat the targeted condition — despite the condition's high incidence and prevalence (e.g., drugs for hypertension or hypercholesterolemia). Since improving the rate of discovery is a rather knotty, multivariate problem, the authors turn to the economic back end of the process. They make the case for the FDA to move more towards conditional approvals, since no Phase III trial can be large...
Source: In the Pipeline - Category: Chemists Tags: Clinical Trials Source Type: blogs