title: Enrolling Adolescents in Disease/Target-Appropriate Adult Oncology Clinical Trials of Investigational Agents.
abstract: The enrollment of adolescents with cancer in clinical trials is much lower than that of younger pediatric patients. For adolescents with "adult-type" cancers, lack of access to relevant trials is cited as one of the reasons for this discrepancy. Adolescents are generally not eligible for enrollment in adult oncology trials, and initial pediatric trials for many drugs are conducted years later, often after the drug is approved. As a result, accrual of adolescents to these trials may be slow due to off-label use, prospectively collected safety and efficacy data are lacking at the time of initial approval, and, most importantly, these adolescents have delayed access to effective therapies. To facilitate earlier access to investigational and approved drugs for adolescent patients with cancer, and because drug exposure is most often similar in adolescents and adults, we recommend the inclusion of adolescents (ages 12-17) in disease- and target-appropriate adult oncology trials. This approach requires careful monitoring for any differential safety signals, appropriate pharmacokinetic evaluations, and ensuring that ethical requirements are met. Inclusion of adolescents in adult oncology trials will require the cooperation of investigators, cooperative groups, industry, institutional review boards, and regulatory agencies to overcome real and perceived barriers. Clin Cancer Res; 23(1); 9-12. ©2016 AACR.
authors: Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland. Meredith.Chuk@fda.hhs.gov.
authors: Meredith K
authors: MK
authors: Chuk
authors: Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors: Yeruk
authors: Y
authors: Mulugeta
authors: Office of Pediatric Therapeutics, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors: Michelle
authors: M
authors: Roth-Cline
authors: Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors: Nitin
authors: N
authors: Mehrotra
authors: Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors: Gregory H
authors: GH
authors: Reaman
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000970:Antineoplastic Agents / Q000494:pharmacology / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000941:ethics / Q000592:standards; D015507:Drugs, Investigational / Q000494:pharmacology / Q000627:therapeutic use; D006801:Humans; D018579:Patient Selection / Q000941:ethics
chemical_list: D000970:Antineoplastic Agents; D015507:Drugs, Investigational