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
Autor: | Binsheng Zhao, Camelia S. Sima, Kai Hsiung Lin, Dyana K. Sumner, Michelle S. Ginsberg, Lauren J. Rogak, M. Catherine Pietanza, Alison Berkowitz-Hergianto, Marwan Shouery, Samantha Lindsay Kass, Mark G. Kris, Ethan Basch, Aaron Gabow, Mary Shaw, Lawrence H. Schwartz, Alex E. Lash, Manda Wilson, Marcia Latif, Leslie B. Tyson, Qinfei Wu, Claire Miller |
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Rok vydání: | 2013 |
Předmět: |
Cancer Research
medicine.medical_specialty Lung Neoplasms Patients MEDLINE Health informatics Phase (combat) Documentation Clinical Trials Phase II as Topic Surveys and Questionnaires Medicine Adverse Drug Reaction Reporting Systems Humans Medical physics Karnofsky Performance Status Adverse effect Point of care business.industry ORIGINAL REPORTS Clinical trial Treatment Outcome Oncology Informatics Self Report business Medical Informatics Software |
Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 31(16) |
ISSN: | 1527-7755 |
Popis: | Purpose In clinical trials, traditional monitoring methods, paper documentation, and outdated collection systems lead to inaccuracies of study information and inefficiencies in the process.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. |
Databáze: | OpenAIRE |
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