Kong, Yuan
(2009)
PREDICTION OF ACCRUAL CLOSURE DATE IN MULTI-CENTER CLINICAL TRIALS WITH POISSON PROCESS MODELS.
Doctoral Dissertation, University of Pittsburgh.
(Unpublished)
Abstract
Objective: To develop a systematic statistical approach to estimate accrual closure date in large scale multi-center clinical trials or large public health studies. It is relevant to the research in public health. Background: In a typical multi-center cancer clinical trial or large public health study, sample size is predetermined to achieve desired power and study participants are enrolled from hundreds of satellite sites. As the accrual is closing to the target size, the coordinating data center needs to project an accrual closure date based on observed accrual pattern and notify participating sites several weeks in advance. In the past, projections were simply based on some crude assessment and conservative measures were incorporated in order to achieve the target accrual size. The resulted excessive accrual size usually leads to unnecessary budget increase considering that the coordinating center needs to pay thousands of dollars for each accrued participant.Method: For multi-center clinical trials, there is very small probability for a site to accrue a patient during a short period and mostly the accrual from different sites is mostly independent from each other. Therefore, the overall accrual could be modeled by a Poisson process. Based on accrual data collected up to a time point, a Poisson process-based method was used to analyze the past accrual pattern. Combining with assumption on the future accruing pattern, two methods were proposed here to predict the accrual closure date. The estimates and their confidence intervals were used to guide clinical practice. The proposed methods were illustrated through analysis of accrual data from NSABP trials B-38 and C-08.
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Details
| Item Type: |
University of Pittsburgh ETD
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| Status: |
Unpublished |
| Creators/Authors: |
|
| ETD Committee: |
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| Date: |
29 September 2009 |
| Date Type: |
Completion |
| Defense Date: |
31 July 2009 |
| Approval Date: |
29 September 2009 |
| Submission Date: |
30 June 2009 |
| Access Restriction: |
No restriction; Release the ETD for access worldwide immediately. |
| Institution: |
University of Pittsburgh |
| Schools and Programs: |
School of Public Health > Biostatistics |
| Degree: |
PhD - Doctor of Philosophy |
| Thesis Type: |
Doctoral Dissertation |
| Refereed: |
Yes |
| Uncontrolled Keywords: |
multicenteral clinical trials; Poisson process |
| Other ID: |
http://etd.library.pitt.edu/ETD/available/etd-06302009-223207/, etd-06302009-223207 |
| Date Deposited: |
10 Nov 2011 19:49 |
| Last Modified: |
15 Nov 2016 13:45 |
| URI: |
http://d-scholarship.pitt.edu/id/eprint/8240 |
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