Microcomputer-assisted data management for multiinstitutional pediatric clinical cancer trials. 1987

P S Gaynon, and E S Baum, and C Samsel, and H Sather

Microcomputer assisted data management techniques, utilized in the oversight of two multiinstitutional trials for children with previously untreated acute lymphoblastic leukemia and unfavorable prognostic features, are presented. In the first study, such oversight hastened identification of unexpectedly prolonged delays, so that treatment could be successfully modified. In the second study, inferiority of one therapy was rapidly demonstrated, and after careful review that therapy was halted. Performance monitoring is discussed in terms of consideration of the overall quality of a clinical trial, namely, how complete are the data submitted and how precisely was protocol therapy administered; measurement of the quality of institutional participation, and identification of deficiencies in reporting or performance in the records of individual patients.

UI MeSH Term Description Entries
D007223 Infant A child between 1 and 23 months of age. Infants
D007945 Leukemia, Lymphoid Leukemia associated with HYPERPLASIA of the lymphoid tissues and increased numbers of circulating malignant LYMPHOCYTES and lymphoblasts. Leukemia, Lymphocytic,Lymphocytic Leukemia,Lymphoid Leukemia,Leukemias, Lymphocytic,Leukemias, Lymphoid,Lymphocytic Leukemias,Lymphoid Leukemias
D008297 Male Males
D008838 Microcomputers Small computers using LSI (large-scale integration) microprocessor chips as the CPU (central processing unit) and semiconductor memories for compact, inexpensive storage of program instructions and data. They are smaller and less expensive than minicomputers and are usually built into a dedicated system where they are optimized for a particular application. "Microprocessor" may refer to just the CPU or the entire microcomputer. Computers, Personal,Microprocessors,Computer, Personal,Microcomputer,Microprocessor,Personal Computer,Personal Computers
D009096 Multi-Institutional Systems Institutional systems consisting of more than one health facility which have cooperative administrative arrangements through merger, affiliation, shared services, or other collective ventures. Multi-Hospital Systems,Multi-Institutional System,Multihospital Systems,System, Multi-Hospital,System, Multi-Institutional,Systems, Multi-Institutional,Multi Hospital Systems,Multi Institutional System,Multi Institutional Systems,Multi-Hospital System,Multihospital System,System, Multi Hospital,System, Multi Institutional,System, Multihospital,Systems, Multi Institutional,Systems, Multi-Hospital,Systems, Multihospital
D009369 Neoplasms New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms. Benign Neoplasm,Cancer,Malignant Neoplasm,Tumor,Tumors,Benign Neoplasms,Malignancy,Malignant Neoplasms,Neoplasia,Neoplasm,Neoplasms, Benign,Cancers,Malignancies,Neoplasias,Neoplasm, Benign,Neoplasm, Malignant,Neoplasms, Malignant
D011379 Prognosis A prediction of the probable outcome of a disease based on a individual's condition and the usual course of the disease as seen in similar situations. Prognostic Factor,Prognostic Factors,Factor, Prognostic,Factors, Prognostic,Prognoses
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D002675 Child, Preschool A child between the ages of 2 and 5. Children, Preschool,Preschool Child,Preschool Children
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic

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