title: Characteristics and temporal trends in patient registries: focus on the life sciences industry, 1981-2012.
abstract: OBJECTIVE
  Patient registries are used to monitor safety, examine real-world effectiveness, and may potentially contribute to comparative effectiveness research. To our knowledge, life sciences industry (LSI)-sponsored registries have not been systematically categorized. This study represents a first step toward understanding such registries over time.
  
  
  METHODS
  Studies described as registries were identified in the ClinicalTrials.gov database. Characteristics from these registry records were abstracted and analyzed.
  
  
  RESULTS
  Of 1202 registries identified, approximately 47% reported LSI sponsorship. These 562 LSI registries varied in focus: medical devices (n = 193, 34%), specific drugs (n = 173, 31%), procedures (n = 29, 5%), or particular diseases (n = 139, 25%). Thirty-three registries (<6%) evaluated pregnancy outcomes. The most common therapeutic area was cardiovascular (n = 234, 42%); others included endocrinology, immunology, oncology, musculoskeletal disorders, and neurology. The two most often measured outcomes were clinical effectiveness and safety, each of which appeared in 363/562 (65%) of LSI registries. Other outcomes included real-world clinical practice patterns (n = 122, 22%), patient-reported outcomes (n = 106, 19%), disease epidemiology/natural history (n = 69, 12%), and economic outcomes (n = 30, 5%). The number of LSI registries and their geographic diversity has increased over time.
  
  
  CONCLUSIONS
  The LSI registries represent a substantial proportion of all patient registries documented in ClinicalTrials.gov. These prospective studies are growing in number and encompass diverse therapeutic areas and geographic regions. Most registries measure multiple outcomes and capture real-world data that may be unavailable through other study designs. This classification of LSI registries documents their use for studying heterogeneity of diseases, examining treatment patterns, measuring patient-reported outcomes, examining economic outcomes, and performing comparative effectiveness research.
authors: Evidera, Lexington, MA, USA.
authors: Karin
authors: K
authors: Travers
authors: Rachel H
authors: RH
authors: Sallum
authors: Meghan D
authors: MD
authors: Burns
authors: Charles E
authors: CE
authors: Barr
authors: Mary S
authors: MS
authors: Beattie
authors: Chris L
authors: CL
authors: Pashos
authors: Bryan R
authors: BR
authors: Luce
mesh_terms: D000014:Abnormalities, Drug-Induced; D001690:Biological Science Disciplines; D016208:Databases, Factual / Q000639:trends*; D005260:Female; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D011247:Pregnancy; D011256:Pregnancy Outcome; D012042:Registries / Q000706:statistics & numerical data*
keywords: ClinicalTrials.gov; industry; pharmacoepidemiology; registry; sponsor