Clinical Research Paper

(2) What are the characteristics of a well-designed clinical trialprotocol that can measure effectiveness of MT in palliative care and EOL settings and can be used for a future large scale study?Based on best practices from the review, we developed a clinical trial protocol and tested its feasibility. Approximately 25% of eligible participants chose to participate.

Although increase in OS remains the ultimate goal of many clinical trials, the choice of OS benefit as a mandatory requirement to register new compounds can lead to a serious underestimation of a drug's real efficacy.

This study provides a detailed description and characterization of the preparation of individualized lots of autologous heat inactivated HIV-1 virions used as immunogen in a clinical trial designed to test an autologous...

Purpose: Because of the high cost of hepatic Overall Survival Is Not a Realistic End Point for Clinical Trials of New Drugs in Advanced Solid Tumors: A Critical Assessment Based on Recently Reported Phase III Trials in Colorectal and Breast Cancer... Memorial Sloan-Kettering Cancer Center, New York, NY. University of California San Francisco, San Francisco, CA. Four phase III clinical trials comparing a fluorouracil-based regimen with the same regimen plus either CPT-11 or oxaliplatin in advanced colorectal cancer patients were reviewed.

Memorial Sloan-Kettering Cancer Center, New York, NY. University of California San Francisco, San Francisco, CA. Postoperative chemotherapy with fluorouracil and levamisole is the standard of care for patients with stage III colon cancer, and postoperative high-dose pelvic radiation combined with fluorouracil is the standard regimen for patients with stage II and III rectal cancer.

statistical power, cross-over, magnitude of the effect on RR and TTP, non-tumor-related deaths) were systematically reviewed in the trials, and the detectable 1-year OS difference, assuming a statistical power of 80%, was calculated for each.

None of these reasons for the lack of OS advantage in presence of RR and TTP benefits convincingly explained the results of the evaluated trials.Background: Approximately 20% of patients with colorectal cancer die of metastases confined to the liver. Is overall survival a realistic primary end point in advanced colorectal cancer studies?A meta- analysis recently performed by our group confirmed that in these patients hepatic arterial infusion of 5-fluoro-2*-... A critical assessment based on four clinical trials comparing fluorouracil plus leucovorin with the same treatment combined either with oxaliplatin or with CPT-11The adequacy of overall survival (OS) as study end point in phase III trials for advanced solid tumors is questionable. But recent studies demonstrate significant improvement in disease-free survival and overall survival for patients with advanced colon and rectal cancer who receive adjuvant therapy. Surgery alone is inadequate therapy in as many as 50% of patients.The consent rate was 55% with70% of participants completing all MT sessions.All participants completed more than 60% of questionnaires.This article will describe the duties of clinical research coordinators, discuss how to stimulate their performance, and explore the training impact on CRCs.Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia: Comparison of Survival in Patients With an Available Donor Compared to Patients Without a Donor in Patients Up to Age 75Clinical investigation of autologous hematopoietic stem cell transplantation (HSCT) as therapy for multiple sclerosis (MS) has been ongoing for over a decade.Three of the four trials had roughly the same statistical power to detect 1-year OS differences, while the fourth trial was underpowered to detect realistic OS differences.The lack of OS advantage observed in the two oxaliplatin trials is therefore likely fortuitous, and due to lack of statistical power.

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