title: Project Zero Delay: a process for accelerating the activation of cancer clinical trials.
abstract: Drug development in cancer research is lengthy and expensive. One of the rate-limiting steps is the initiation of first-in-human (phase I) trials. Three to 6 months can elapse between investigational new drug (IND) approval by the US Food and Drug Administration and the entry of a first patient. Issues related to patient participation have been well analyzed, but the administrative processes relevant to implementing clinical trials have received less attention. While industry and academia often partner for the performance of phase I studies, their administrative processes are generally performed independently, and their timelines driven by different priorities: safety reviews, clinical operations, regulatory submissions, and contracting of clinical delivery vendors for industry; contracts, budgets, and institutional review board approval for academia. Both processes converge on US Food and Drug Administration approval of an IND. In the context of a strategic alliance between M. D. Anderson Cancer Center and AstraZeneca Pharmaceuticals LP, a concerted effort has been made to eliminate delays in implementing clinical trials. These efforts focused on close communications, identifying and matching key timelines, alignment of priorities, and tackling administrative processes in parallel, rather than sequentially. In a recent, first-in-human trial, the study was activated and the first patient identified in 46 days from completion of the final study protocol and about 48 hours after final US Food and Drug Administration IND approval, reducing the overall timeline by about 3 months, while meeting all clinical good practice guidelines. Eliminating administrative delays can accelerate the evaluation of new drugs without compromising patient safety or the quality of clinical research.
authors: Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), Division of Cancer Medicine, M. D. Anderson Cancer Center, Unit 455, PO Box 301402 Houston, TX 77030, USA. rkurzroc@mdanderson.org
authors: Razelle
authors: R
authors: Kurzrock
authors: Susan
authors: S
authors: Pilat
authors: Marcel
authors: M
authors: Bartolazzi
authors: Dwana
authors: D
authors: Sanders
authors: Jill
authors: J
authors: Van Wart Hood
authors: Stanley D
authors: SD
authors: Tucker
authors: Kevin
authors: K
authors: Webster
authors: Michael A
authors: MA
authors: Mallamaci
authors: Steven
authors: S
authors: Strand
authors: Eileen
authors: E
authors: Babcock
authors: Robert C
authors: RC
authors: Bast
mesh_terms: D035843:Biomedical Research; D017321:Clinical Trials, Phase I as Topic; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods*; D004345:Drug Industry; D015507:Drugs, Investigational / Q000627:therapeutic use*; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015507:Drugs, Investigational