title: PhRMA survey on the conduct of first-in-human clinical trials under exploratory investigational new drug applications.
abstract: The FDA guidance on exploratory IND studies is intended to enable sponsors to move ahead more efficiently with the development of promising candidates. A survey of PhRMA member companies was conducted in 2007 to obtain a cross-sectional industry perspective on the current and future utility of exploratory IND studies. About 56% of survey responders (9 companies of 16 survey responders) conducted or were planning to conduct clinical studies under exploratory INDs. The majority of microdosing studies are performed to characterize human pharmacokinetics or to examine target organ pharmacokinetics using PET imaging techniques. On the other hand, the majority of pharmacological end point studies conducted under exploratory IND are performed to determine whether the compound modulated its pharmacological target or to evaluate the degree of saturation of a target receptor. The present survey suggests that although the merits of exploratory INDs are still being debated, the diversity in the applications cited, the potential for early clinical guidance in decision making and the increasing pressure on containing drug development costs, suggest that the exploratory IND/CTA will be a valuable option with evolving and possibly more specific applications for the future.
authors.affiliation: Hoffmann-La Roche, Clinical Research and Exploratory Development, Clinical Pharmacology, 340 Kingsland Street, Nutley NJ 07110-1199, USA.
authors.forename: Adel H
authors.initials: AH
authors.lastname: Karara
authors.forename: Timi
authors.initials: T
authors.lastname: Edeki
authors.forename: James
authors.initials: J
authors.lastname: McLeod
authors.forename: Alfred P
authors.initials: AP
authors.lastname: Tonelli
authors.forename: John A
authors.initials: JA
authors.lastname: Wagner
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003430:Cross-Sectional Studies; D055808:Drug Discovery / Q000379:methods; D004345:Drug Industry / Q000379:methods*; D015507:Drugs, Investigational / Q000493:pharmacokinetics / Q000627:therapeutic use; D006801:Humans; D017387:Investigational New Drug Application; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015507:Drugs, Investigational