title: Harnessing technology to improve clinical trials: study of real-time informatics to collect data, toxicities, image response assessments, and patient-reported outcomes in a phase II clinical trial.
abstract: OBJECTIVE
  In clinical trials, traditional monitoring methods, paper documentation, and outdated collection systems lead to inaccuracies of study information and inefficiencies in the process. Integrated electronic systems offer an opportunity to collect data in real time.
  
  
  METHODS
  We created a computer software system to collect 13 patient-reported symptomatic adverse events and patient-reported Karnofsky performance status, semi-automated RECIST measurements, and laboratory data, and we made this information available to investigators in real time at the point of care during a phase II lung cancer trial. We assessed data completeness within 48 hours of each visit. Clinician satisfaction was measured.
  
  
  RESULTS
  Forty-four patients were enrolled, for 721 total visits. At each visit, patient-reported outcomes (PROs) reflecting toxicity and disease-related symptoms were completed using a dedicated wireless laptop. All PROs were distributed in batch throughout the system within 24 hours of the visit, and abnormal laboratory data were available for review within a median of 6 hours from the time of sample collection. Manual attribution of laboratory toxicities took a median of 1 day from the time they were accessible online. Semi-automated RECIST measurements were available to clinicians online within a median of 2 days from the time of imaging. All clinicians and 88% of data managers felt there was greater accuracy using this system.
  
  
  CONCLUSIONS
  Existing data management systems can be harnessed to enable real-time collection and review of clinical information during trials. This approach facilitates reporting of information closer to the time of events, and improves efficiency, and the ability to make earlier clinical decisions.
authors: Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10065, USA. pietanzm@mskcc.org
authors: M Catherine
authors: MC
authors: Pietanza
authors: Ethan M
authors: EM
authors: Basch
authors: Alex
authors: A
authors: Lash
authors: Lawrence H
authors: LH
authors: Schwartz
authors: Michelle S
authors: MS
authors: Ginsberg
authors: Binsheng
authors: B
authors: Zhao
authors: Marwan
authors: M
authors: Shouery
authors: Mary
authors: M
authors: Shaw
authors: Lauren J
authors: LJ
authors: Rogak
authors: Manda
authors: M
authors: Wilson
authors: Aaron
authors: A
authors: Gabow
authors: Marcia
authors: M
authors: Latif
authors: Kai-Hsiung
authors: KH
authors: Lin
authors: Qinfei
authors: Q
authors: Wu
authors: Samantha L
authors: SL
authors: Kass
authors: Claire P
authors: CP
authors: Miller
authors: Leslie
authors: L
authors: Tyson
authors: Dyana K
authors: DK
authors: Sumner
authors: Alison
authors: A
authors: Berkowitz-Hergianto
authors: Camelia S
authors: CS
authors: Sima
authors: Mark G
authors: MG
authors: Kris
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D017322:Clinical Trials, Phase II as Topic / Q000379:methods / Q000639:trends; D006801:Humans; D017567:Karnofsky Performance Status; D008175:Lung Neoplasms; D008490:Medical Informatics / Q000639:trends*; D010361:Patients; D057566:Self Report; D012984:Software; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
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