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Information about ongoing health services research and public health projects
| Toxicity burden summary from chemotherapy in cancer trials | |
|---|---|
| Investigator (PI): | Lee, Shing |
| Performing Organization (PO): |
(Current): Columbia University, Mailman School of Public Health, Department of Biostatistics / (212) 305-9398 |
| Supporting Agency (SA): | American Cancer Society |
| Initial Year: | 2013 |
| Final Year: | 2017 |
| Record Source/Award ID: | ACS/MRSG-13-146-01 |
| Funding: | Total Award Amount: $582,000 |
| Award Type: | Grant |
| Abstract: | In cancer clinical trials, a large amount of adverse event data are collected. For each adverse event, the National Cancer Institute Common Terminology Criteria for Adverse Events is used to quantify its severity. These data are then summarized across a wide range of adverse events into a single outcome called dose-limiting toxicity. This summary measure does not take into account the entire adverse event gradation or differentiate among the various adverse event types. Thus, it does not adequately quantify the toxicity burden experienced by patients. A poorly defined summary of toxicity may contribute to the high attrition rate in clinical trials during drug development because of higher than expected toxicity burden and poor adherence to treatment. This project will develop a novel approach to summarize the large amount of adverse event data collected and evaluate the differences among toxicity burden assessments obtained from clinicians versus patients themselves. We will evaluate the feasibility of obtaining toxicity burden assessments directly from physicians, nurses, and patients themselves by developing a scale for overall toxicity burden and eliciting their respective toxicity burden scores. Using the scale and adverse event data from patients previously enrolled in a randomized clinical trial, we will obtain toxicity burden assessment from physicians and nurses and evaluate several regression approaches to estimate the severity weights to be used to summarize the toxicities via a weighted sum of grades and types of toxicities. The method improves upon the current summary practices and research methods by using clinician input to obtain the weights and taking into account the toxicity severity gradation. In addition, we will compare the overall toxicity burden assessments by physicians, nurses, and patients against clinical outcomes and with each other. This project extends our previous work which demonstrated the feasibility of using a regression approach for a single small clinical trial with the participation of three physicians. This grant will allow us to evaluate and validate the method in a larger data set, explore models that can be generalized to various types of cancers and treatments, and compare the toxicity burden assessments among physicians, nurses, and patients. A method that adequately summarizes toxicities will have an impact in all phases of drug development and cancer care. It will provide a more sensitive toxicity outcome in early phase clinical trials and allow for adverse event comparison of treatments and patient populations. As a result, investigators will have a better understanding of the toxicity burden of therapies which may increase the efficiency of the clinical trial enterprise by decreasing the attrition rate in clinical trials due to toxicity. |
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| Country: | United States |
| State: | New York |
| Zip Code: | 10032 |
| UI: | 20163122 |
| Project Status: | Completed |