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.

TitleHarnessing 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.
Publication TypeJournal Article
Year of Publication2013
AuthorsPietanza CM, Basch EM, Lash A, Schwartz LH, Ginsberg MS, Zhao B, Shouery M, Shaw M, Rogak LJ, Wilson M, Gabow A, Latif M, Lin K-, Wu Q, Kass SL, Miller CP, Tyson L, Sumner DK, Berkowitz-Hergianto A, Sima CS, Kris MG
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume31
Issue16
Pagination2004-9
Date Published2013 Jun 1
ISSN1527-7755
KeywordsAdverse Drug Reaction Reporting Systems; Clinical Trials, Phase II as Topic; Humans; Karnofsky Performance Status; Lung Neoplasms; Medical Informatics; Patients; Questionnaires; Self Report; Software; Treatment Outcome
AbstractPURPOSE: In clinical trials, traditional monitoring methods, paper documentation, and outdated collection systems lead to inaccuracies of study information and inefficiencies in the process.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. PATIENTS AND 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. CONCLUSION: 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.
URLhttp://jco.ascopubs.org/content/31/16/2004.long
DOI10.1200/JCO.2012.45.8117
Alternate JournalJ. Clin. Oncol.