Contemporary clinical trials
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Contemp Clin Trials · Jan 2008
Optimal and minimax three-stage designs for phase II oncology clinical trials.
The common objective of oncology phase II trials is to evaluate the anti-tumor activity of a new agent and to determine whether the new drug warrants further investigation. For cancer drugs that significantly shrink tumors, response (CR and PR) rate is usually the primary endpoint in cancer phase II trials for testing H(0): P
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Contemp Clin Trials · Jan 2008
Concordance of Medicaid and pharmacy record data in inner-city children with asthma.
Management of asthma involves adherence to medication regimens. Assessing adherence is difficult for health care providers and researchers. Self-reported medication use is subjective, so objective methods of data collection for medication use are frequently used in asthma research. The aim of this project is to examine the concordance between asthma medication pharmacy data culled from Medicaid claims data ("Medicaid pharmacy data") and patient pharmacy record data obtained from individual pharmacies ("pharmacy record data"). ⋯ There was overlap between the pharmacy data captured by the Medicaid pharmacy dataset and pharmacy record dataset, but the overall concordance between the two data collection methods was low. Pharmacy records collected directly from the pharmacy included data on more subjects and pharmacy data culled from Medicaid claims captured more total number of claims. In spite of the differences in the methods used to collect data, pharmacy fill records are a rich source of data with both clinical and research applications. Clinicians and researchers must weigh the benefits and limitations of each method used to collect pharmacy data.
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Contemp Clin Trials · Sep 2007
Patient recruitment into a randomised controlled trial of supervised exercise therapy in sedentary women treated for breast cancer.
The purpose of this study was to determine the effectiveness of different recruitment strategies used to recruit patients into the Sheffield Exercise and Breast Cancer Trial (SHERBERT), which involved exercise as a therapy, in sedentary women treated for breast cancer. We also evaluated whether the routes of recruitment distinguished patients participating in the trial in terms of socio-economic characteristics, lifestyle behaviours, cancer treatment(s), treatment side effects, length of treatment and time since treatment was completed. ⋯ The number of patients randomised was marginally lower than anticipated. We were able to identify and highlight valuable information for planning the recruitment of future trials involving similar populations.
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Contemp Clin Trials · Jul 2007
Randomized Controlled Trial Comparative StudyThe Best Bypass Surgery Trial: rationale and design of a randomized clinical trial with blinded outcome assessment of conventional versus off-pump coronary artery bypass grafting.
Recent trials suggest that off-pump coronary artery bypass grafting (OPCAB) reduces the risk of mortality and morbidity compared with conventional coronary artery bypass grafting (CCAB) using cardiopulmonary bypass. Patients with a moderate- to high-risk of complications after CCAB may have additional benefit from OPCAB. ⋯ The results may have implications on the treatment modality of moderate- to high-risk patients scheduled for coronary artery bypass grafting.