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PREDICTION OF ACCRUAL CLOSURE DATE IN MULTI-CENTER CLINICAL TRIALS WITH POISSON PROCESS MODELS

Kong, Yuan (2009) PREDICTION OF ACCRUAL CLOSURE DATE IN MULTI-CENTER CLINICAL TRIALS WITH POISSON PROCESS MODELS. Doctoral Dissertation, University of Pittsburgh. (Unpublished)

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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
Status: Unpublished
Creators/Authors:
CreatorsEmailPitt UsernameORCID
Kong, Yuankongyuan99@yahoo.com
ETD Committee:
TitleMemberEmail AddressPitt UsernameORCID
Committee ChairTang, Gonggot1@pitt.eduGOT1
Committee MemberChang, Chung-Chou Hochangjh@upmc.edu
Committee MemberCostantino, Joseph P.costan@nsabp.pitt.eduCOSTAN
Committee MemberKong, Lanlkong@pitt.eduLKONG
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: Graduate 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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