@article{b98e369bf42641908cc4b0c645022c9b,
title = "The importance of greater speed in drug development for advanced malignancies",
abstract = "It takes on average 6–12 years to develop new anticancer drugs from discovery to approval. Effective new agents prolong survival. To demonstrate the importance of rapid drug approval, we calculated life-years potentially saved if selected agents were approved more rapidly. As illustrative examples, we used 27 trials documenting improvements in survival. We multiplied improvement in median survival by numbers of patients dying annually and multiplied this by number of years from drug discovery until approval. For every year by which time to drug approval could have been shortened, there would have been a median number of life-years potentially saved of 79,920 worldwide per drug. Median number of life-years lost between time of drug discovery and approval was 1,020,900 per example. If we were able to use available opportunities to decrease the time required to take a drug from discovery to approval to 5 years, the median number of life-years saved per example would have been 523,890 worldwide. Various publications have identified opportunities to speed drug development without sacrificing patient safety. While many investigational drugs prove to be ineffective, some significantly prolong survival and/or reduce suffering. These illustrative examples suggest that a substantial number of life-years could potentially be saved by increasing the efficiency of development of new drugs for advanced malignancies.",
keywords = "Cancer, drug approval, drug development, life-years saved",
author = "Stewart, {David J.} and Stewart, {Andrew A.} and Paul Wheatley-Price and Gerald Batist and Kantarjian, {Hagop M.} and Joan Schiller and Mark Clemons and Bradford, {John Peter} and Laurel Gillespie and Razelle Kurzrock",
note = "Funding Information: Dr. D. J. Stewart has received advisory board fees from Amgen, Roche Canada, Pfizer Canada, Boehringer Ingleheim Canada, and Novartis Canada, honoraria from Pfizer Canada and from the International Association for the Study of Lung Cancer, research funding from Celgene, Pfizer Canada and Roche Canada, and is Lead Advisor on the Life-Saving Therapies Network. J.-P. Bradford is President of Bradford Bachinski Limited, CEO of the LifeSaving Therapies Network, cochair of the Advocacy Committee of Lung Cancer Canada, a member of the Cancer Care Advisory Committee of the Ottawa Regional Cancer Foundation, and a member of the Research Advisory Committee of the Canadian Partnership Against Cancer. Dr. R. Kurzrock has research funds from Incyte, Genentech, Merck Serono, Foundation Medicine, Guardant, Sequenom and Pfizer, as well as consultant fees from Acutate Therapeutics, XBiotech and Loxo, speaker fees from Roche, and an ownership interest in CureMatch Inc. Dr. J. H. Schiller is President of Free to Breathe, has done consulting and participated in advisory boards for Synta, Vertex, Genentech, Clovis, Biodesix, AVEO, Eisai, AbbVie, Lilly, Merck, and AstraZeneca, and has participated in clinical research with Clovis, AbbVie, Astex, Jannsen, Genentech, Synta, Sorono/EMD, Pfizer, PUMA, and Johnson & Johnson. Dr. G. Batist has received support for research from Pfizer and works in an academic-industry Consortium that includes Merck, Roche, Pfizer, Amgen, Bayer, Novartis. Publisher Copyright: {\textcopyright} 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.",
year = "2018",
month = may,
doi = "10.1002/cam4.1454",
language = "English (US)",
volume = "7",
pages = "1824--1836",
journal = "Cancer medicine",
issn = "2045-7634",
publisher = "John Wiley and Sons Ltd",
number = "5",
}