Prediction of accrual closure date in multi-center clinical trials with discrete-time Poisson process models

Gong Tang, Yuan Kong, Chung Chou Ho Chang, Lan Kong, Joseph P. Costantino

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

In a phase III multi-center cancer clinical trial or a large public health study, sample size is predetermined to achieve desired power, and study participants are enrolled from tens or hundreds of participating institutions. As the accrual is closing to the target size, the coordinating data center needs to project the accrual closure date on the basis of the observed accrual pattern and notify the 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. This approach often resulted in excessive accrual size and subsequently unnecessary financial burden on the study sponsors. Here we proposed a discrete-time Poisson process-based method to estimate the accrual rate at time of projection and subsequently the trial closure date. To ensure that target size would be reached with high confidence, we also proposed a conservative method for the closure date projection. The proposed method was illustrated through the analysis of the accrual data of the National Surgical Adjuvant Breast and Bowel Project trial B-38. The results showed that application of the proposed method could help to save considerable amount of expenditure in patient management without compromising the accrual goal in multi-center clinical trials.

Original languageEnglish (US)
Pages (from-to)351-356
Number of pages6
JournalPharmaceutical Statistics
Volume11
Issue number5
DOIs
StatePublished - Sep 1 2012

Fingerprint

Poisson Model
Poisson process
Date
Clinical Trials
Process Model
Closure
Discrete-time
Prediction
Projection
Target
Data Center
Public Health
Health Expenditures
Sample Size
Confidence
Cancer
Breast
Estimate
Neoplasms

All Science Journal Classification (ASJC) codes

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

Cite this

Tang, Gong ; Kong, Yuan ; Chang, Chung Chou Ho ; Kong, Lan ; Costantino, Joseph P. / Prediction of accrual closure date in multi-center clinical trials with discrete-time Poisson process models. In: Pharmaceutical Statistics. 2012 ; Vol. 11, No. 5. pp. 351-356.
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Prediction of accrual closure date in multi-center clinical trials with discrete-time Poisson process models. / Tang, Gong; Kong, Yuan; Chang, Chung Chou Ho; Kong, Lan; Costantino, Joseph P.

In: Pharmaceutical Statistics, Vol. 11, No. 5, 01.09.2012, p. 351-356.

Research output: Contribution to journalArticle

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