Efforts toward qualitative and quantitative improvements of cancer clinical trials at regional designated cancer care hospitals - Through full support for cancer clinical trials by oncology pharmacy specialist and data manager
Morimoto S.,Osakaminami Medical Center |
Inoue R.,Osakaminami Medical Center |
Shono Y.,Osakaminami Medical Center |
Horiuchi T.,Osakaminami Medical Center |
And 5 more authors.
Japanese Journal of Cancer and Chemotherapy | Year: 2011
Cancer clinical trials are performed in a large-scale, controlled, and multicenter fashion to provide the highest level of evidence-based medicine (EBM) possible. As these trials require high-quality execution, the presence of competent support staff is vital. Regional designated cancer care hospitals must develop more solid systems to promote cancer clinical trials and to increase physicians' awareness of those trials. Our center recruited a cancer clinical trial data manager (DM) in addition to an/a oncology pharmacy specialist (s) with the intention to expand cancer clinical trials throughout the center with their full support. The present study examined the resulting changes with respect to trial promptness and accuracy. Oncology pharmacy specialist (s) concentrated on trial content description, informed consent acquisition, and status management. DM initiated tasks focusing on the calendar monitoring of blood and imaging tests for "qualitative improvement." Furthermore, in terms of "quantitative improvement," oncology pharmacy specialist (s) explored cancer clinical trials, while both oncology pharmacy specialist (s) and DM attended conferences to actively screen patients eligible for registration. A system was put in place in which DM prepared materials for the Ethics Committee and completed Case Report Forms (CRFs) for verification by physicians and oncology pharmacy specialist (s). The results showed an increase in the number of contract clinical trials, a shortened first-time patient registration period, increased enrollment, a more accurate protocol implementation, greater adverse reaction monitoring from the pharmacist's perspective, and more accurately filled CRFs as well as their prompt submission. The present study suggested that full support for cancer clinical trials by the cooperative work of oncology pharmacy specialist (s) and DM would help establish a system in which high-level trials-both qualitatively and quantitatively-can be carried out. This approach will prove effective in expanding cancer clinical trials at regional designated cancer care hospitals. Source
Hayashi R.,Osakaminami Medical Center |
Kajimoto T.,Osakaminami Medical Center |
Sawamura M.,Osakaminami Medical Center |
Hirao R.,Osakaminami Medical Center |
And 16 more authors.
Journal of the Japan Diabetes Society | Year: 2014
We invented a collaborative computer system that uses a summary sheet for collecting diabetes care data, including the disease duration, physiological test results, biochemical data, diabetic complications and treatments. This practical system is useful for obtaining an overview of the disease and may be completed in four steps: 1' Developing the basic summary sheet, 2' Entering the data into the electronic medical recording system, 3' Collaborating with other medical staff when making each data sheet and 4' Converting the data sheet to the popular form of diabetic communication notes. The introduction of an automatic downloading system and the capacity for premanipulation by medical staff, including medical assistants, may make each step faster. The shorter the process, the more patients can be assessed. This system is very useful for developing diabetic community medicine via the use of electronic summary sheets adapted to conventional communication notes. Source