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 Journal Article


Authors: Pietanza, M. C.; Basch, E. M.; Lash, A.; Schwartz, L. H.; Ginsberg, M. S.; Zhao, B.; Shouery, M.; Shaw, M.; Rogak, L. J.; Wilson, M.; Gabow, A.; Latif, M.; Lin, K. H.; Wu, Q.; Kass, S. L.; Miller, C. P.; Tyson, L.; Sumner, D. K.; Berkowitz-Hergianto, A.; Sima, C. S.; Kris, M. G.
Article 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Abstract: In clinical trials, traditional monitoring methods, paper documentation, and outdated collection systems lead to inaccuracies of study information and inefficiencies in the process.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. 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. 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. 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.
Keywords: treatment outcome; methodology; lung neoplasms; self report; questionnaires; questionnaire; lung tumor; drug surveillance program; adverse drug reaction reporting systems; patients; karnofsky performance status; clinical trials, phase ii as topic; computer program; software; patient; phase 2 clinical trial (topic); medical informatics
Journal Title: Journal of Clinical Oncology
Volume: 31
Issue: 16
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2013-06-01
Start Page: 2004
End Page: 2009
Language: English
DOI: 10.1200/jco.2012.45.8117
PUBMED: 23630218
PROVIDER: scopus
PMCID: PMC4878068
DOI/URL:
Notes: --- - "Export Date: 4 September 2013" - "Source: Scopus"
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MSK Authors
  1. Camelia S Sima
    203 Sima
  2. Michelle S Ginsberg
    154 Ginsberg
  3. Ethan Martin Basch
    150 Basch
  4. Lawrence H Schwartz
    275 Schwartz
  5. Binsheng Zhao
    43 Zhao
  6. Maria C Pietanza
    113 Pietanza
  7. Dyana K Sumner
    4 Sumner
  8. Alex E Lash
    24 Lash
  9. Mark Kris
    581 Kris
  10. Leslie Tyson
    49 Tyson
  11. Lauren Jayne Rogak
    44 Rogak
  12. Samantha Lindsay Kass
    8 Kass
  13. Kai-Hsiung Lin
    4 Lin
  14. Aaron Gabow
    5 Gabow
  15. Manda E Wilson
    5 Wilson
  16. Mary Catherine Shaw
    12 Shaw
  17. Claire Power Miller
    2 Miller