title: Precision medicine clinical trials: defining new treatment strategies.
abstract: OBJECTIVE
  To discuss the role of clinical trials in the changing landscape of cancer care resulting in individualized cancer treatment plans including a discussion of several innovative randomized studies designed to evaluate multiple targeted therapies in molecularly defined subsets of individuals.
  
  
  METHODS
  Medical and nursing literature, research articles, and clinicaltrials.gov.
  
  
  CONCLUSIONS
  Recent advancements in cancer biomarkers and biomedical technology have begun to transform fundamentals of cancer therapeutics and clinical trials through innovative adaptive trial designs. The goal of these studies is to learn not only if a drug is safe and effective but also how it is best delivered and who will derive the most benefit.
  
  
  CONCLUSIONS
  Implementation of clinical trials in the cancer biomarker era requires knowledge, skills, and expertise related to the use of biomarkers and molecularly defined processes underlying a malignancy, as well as an understanding of associated ethical, legal, and social issues to provide competent, safe, and effective health care and patient communication.
authors.forename: Brandy M
authors.initials: BM
authors.lastname: Heckman-Stoddard
authors.forename: Judith J
authors.initials: JJ
authors.lastname: Smith
mesh_terms: D000912:Antibodies, Neoplasm / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D006801:Humans; D058990:Molecular Targeted Therapy / Q000379:methods* / Q000451:nursing; D009369:Neoplasms / Q000188:drug therapy* / Q000451:nursing; D009859:Oncology Nursing / Q000379:methods*; D018802:Patient-Centered Care / Q000379:methods; D057285:Precision Medicine / Q000379:methods* / Q000451:nursing; D016896:Treatment Outcome
chemical_list: D000912:Antibodies, Neoplasm; D000970:Antineoplastic Agents
keywords: Precision medicine; adaptive design; biomarker; clinical trial; molecular targets; research ethics