Accelerating Identification and Regulatory Approval of Investigational Cancer Drugs
Cet article dresse des perspectives pour l'accélération du processus d'autorisation de mise sur le marché de nouveaux médicaments anticancéreux
The development of new drugs is becoming increasingly expensive—and oncology drugs, in particular, have a high clinical failure rate. The current return on capital investment in drug development by US public companies was recently reported as less than 0.3%. The low probability of success, coupled with rapidly accelerating expenses, means that drug development is increasingly the purview of only 2 organization types: a few large companies and myriad small, venture capital–funded start-up firms. At an estimated cost of $1.0 billion to $1.8 billion for developing a successful new drug, funding for such risky ventures, particularly for oncology drugs, may diminish.
The high cost of oncology drug development is not only an issue of finance but also occurs because many cancers are heterogeneous. The inability (or lack of explicit effort) to identify and incorporate specific disease subtypes into trial design inhibits the development of more cost-effective …
JAMA: The Journal of the American Medical Association , commentaire, 2011