prob_lower_site_ae_vs_study_ae

Internal function used by <code>sim_sites()</code>

internal

Monitoring reporting rates of subject-level clinical events (e.g.
adverse events, protocol deviations) reported by clinical trial sites is an
important aspect of risk-based quality monitoring strategy. Sites that are
under-reporting or over-reporting events can be detected using bootstrap
simulations during which patients are redistributed between sites. Site-specific
distributions of event reporting rates are generated that are used to assign
probabilities to the observed reporting rates.
(Koneswarakantha 2024 <doi:10.1007/s43441-024-00631-8>).

Bjoern Koneswarakantha

simaerep

Detect Clinical Trial Sites Over- or Under-Reporting Clinical
Events

F. Hoffmann-La Roche Ltd 

prob_lower_site_ae_vs_study_ae function

<dl><dt>site_ae</dt>
<dd>vector with AE numbers</dd>
<dt>study_ae</dt>
<dd>vector with AE numbers</dd>
<dt>r</dt>
<dd>integer, denotes number of simulations, default = 1000</dd>
<dt>under_only</dt>
<dd>compute under-reporting probabilities only, default = TRUE</dd></dl>

Arguments

Calculate bootstrapped probability for obtaining a lower site mean AE number. — prob_lower_site_ae_vs_study_ae

<dl>

<dt>site_ae</dt>
<dd>vector with AE numbers</dd>


<dt>study_ae</dt>
<dd>vector with AE numbers</dd>


<dt>r</dt>
<dd>integer, denotes number of simulations, default = 1000</dd>


<dt>under_only</dt>
<dd>compute under-reporting probabilities only, default = TRUE</dd>

</dl>

prob_lower_site_ae_vs_study_ae: Calculate bootstrapped probability for obtaining a lower site mean AE number.

Description

Usage

Value

Arguments

Details

See Also

Examples