Accrual of patients into a multihospital cancer clinical trial and its implications on planning future studies
| Autor: | James F. Martin, William G. Henderson, Leo R. Zacharski, Frederick R. Rickles, Walter B. Forman, C. J. Cornell, R. Jackson Forcier, R. L. Edwards, Elwood Headley, Sang-Hee Kim, Joseph F. OʼDonnell, Robert OʼDell, Karl Tornyos, Hau C. Kwaan |
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| Rok vydání: | 1984 |
| Předmět: |
Research design
Male Cancer Research medicine.medical_specialty Randomization media_common.quotation_subject Population MEDLINE Neglect Random Allocation Neoplasms Antineoplastic Combined Chemotherapy Protocols medicine Humans education media_common Protocol (science) education.field_of_study Clinical Trials as Topic business.industry Cancer Middle Aged medicine.disease Surgery Clinical trial Oncology Research Design Population Surveillance Emergency medicine Female Warfarin business |
| Zdroj: | American journal of clinical oncology. 7(2) |
| ISSN: | 0277-3732 |
| Popis: | Little information exists on the population of cancer patients from which individual patients are selected for admission to a clinical trial. In fact, most reports of clinical trials of cancer chemotherapeutic agents begin by describing samples of treated patients but neglect to collect data and describe the population from which the samples were taken. In a multi-institutional VA Cooperative Study in which two different cancer treatments were compared, an attempt was made to screen all lung, colorectal, prostate, and head and neck patients seen at participating hospitals prior to randomization to a therapeutic regimen. Of a total of 2687 patients screened, 437 (16.3%) were randomized and 2250 (83.7%) were excluded for 2981 reasons. Protocol reasons were the basis for 68.6% of all exclusions, 21.3% were physician refusals, and 10.1% were patient refusals. The number of patients randomized did not correlate well with number of patients screened across participating centers. Patients admitted to the study tended to be younger and in better health than excluded patients. Overestimates of randomization rates projected initially from published information point to the need for improved screening data in the planning of future studies. Factors such as screening methods, physician acceptance of the experimental approach, number of competing protocols within each center, and cooperation among medical center departments and personnel all are important ingredients in any screening effort. |
| Databáze: | OpenAIRE |
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