title: Applying the best of oncology drug development paradigms to the non-malignant space.
abstract: With 80-90% of drugs entering the clinic not meeting regulatory approval (a high cost of failure), there is a major need for innovation in the clinical development space. Features of the new era of practice-changing innovation in oncology have included novel clinical trial designs incorporating multiple new molecular entities and/or multiple patient types, patient selection strategies (which allow detection of early signs of efficacy), and use of surrogate endpoints to achieve speedy regulatory approval. Disease areas beyond oncology could benefit from the application of specific aspects of these approaches. Here, we describe several such potential adaptations of the approaches, with scenarios and prerequisites, which could help reduce the costs of, and accelerate, clinical drug development with confidence.
authors.affiliation: Quantitative Clinical Sciences, Pharmatherapeutics, Pfizer Inc., 300 Technology Square, Cambridge, MA 02139, USA. Electronic address: Neil.bhattacharya@pfizer.com.
authors.forename: Indranil
authors.initials: I
authors.lastname: Bhattacharya
authors.affiliation: Quantitative Clinical Sciences, Pharmatherapeutics, Pfizer Inc., 300 Technology Square, Cambridge, MA 02139, USA.
authors.forename: Anne
authors.initials: A
authors.lastname: Heatherington
authors.affiliation: Oncology Clinical Development, ORRD, Pfizer Inc., 10777 Science Center Drive (CB1), San Diego, CA 92121, USA.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Barton
mesh_terms: D000970:Antineoplastic Agents; D055808:Drug Discovery / Q000379:methods*; D006801:Humans; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents