Study-class: Class defining the Study

In scientific-computing-solutions/eventPrediction: Event Prediction in Clinical Trials with Time-to-Event Outcomes

Description

Class defining the Study

Slots

HR

Hazard ratio to be detected

alpha

Significance level [0,1] (see also two-sided indicator)

power

Power [0,1]

two.sided

If TRUE, two sided test will be used (i.e. alpha/2).

r

Control:Experimental subject balance (1:r), i.e. nE/nC=r. r=1 corresponds to equally many subjects in both arms. 2 means we have twice the number of subjects in the experimental arm. Specifically floor(r*N/(r+1)) subjects are allocated to the experimental arm and all other subjects are allocated to the control arm.

N

Number of subjects to be recruited (integer)

study.duration

Number of months the study will be going.

ctrlSpec

A CtrlSpec object which calculates the control group median. This object will be created automatically when calling a constructor for the Study class.

dropout

A list of CtrlSpec object which calculates the median drop out rate for the control arm (index 1) and active arm (index 2). This object will be created automatically when calling a constructor for the study class

dropout.shape

The Weibull shape parameter of the dropout hazard function

k

non-uniformity of accrual (integer, 1=uniform). Non-uniform accrual is allowed for using the following distribution for the probability of a patient entering the trial at time b within the accrual period [0,B]: F(b)=b_k/B_k; f(b)=k b_{k-1}/B_k where k is the measure of non-uniformity (k>0). k=1 indicates uniform accrual. This implies that during the first half of the accrual period, 1/2^k of the patients will be recruited. Half of the patients will be recruited by time B/2^{1/k}.

acc.period

Accrual time in months

shape

The Weibull shape parameter

followup

The time a subject is followed after randomization, if Inf then there is no fixed time period

type

Character: The study type, either "Oncology" or "CRGI"

lag.settings

The LaggedEffect object describing any lag effect for the study

scientific-computing-solutions/eventPrediction documentation built on May 29, 2019, 3:44 p.m.