title: Planning and core analyses for periodic aggregate safety data reviews.
abstract: BACKGROUND
  In 2009, the Safety Planning, Evaluation and Reporting Team gave detailed recommendations for a well-planned and systematic approach for safety data collection and analysis. Important aspects of this approach included regular reviews of aggregate data by a multidisciplinary team focusing on safety.
  
  
  OBJECTIVE
  This article provides information to facilitate the planning and implementation of aggregate data reviews.
  
  
  METHODS
  Our recommendations are based on experience of the authors and review of relevant literature.
  
  
  RESULTS
  We present information regarding the planning of aggregate data reviews as well as examples of data displays that are useful for many different compounds. A subset of these data displays could form a set of 'core' analyses to be generated for aggregate data reviews.
authors.affiliation: Amgen, Inc., Thousand Oaks, CA, USA.
authors.forename: H Amy
authors.initials: HA
authors.lastname: Xia
authors.forename: Brenda J
authors.initials: BJ
authors.lastname: Crowe
authors.forename: Robert C
authors.initials: RC
authors.lastname: Schriver
authors.forename: Manfred
authors.initials: M
authors.lastname: Oster
authors.forename: David B
authors.initials: DB
authors.lastname: Hall
mesh_terms: D026661:Clinical Trials Data Monitoring Committees / Q000458:organization & administration*; D002986:Clinical Trials as Topic / Q000379:methods*; D003625:Data Collection / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control; D006801:Humans; D017751:Safety Management / Q000458:organization & administration*