Methods and apparatus for planning and management of clinical trials
AssigneePAREXEL International Corporation
InventorJoshua Schultz
Life of this patent
Estimating the term…
Abstract
A tool for planning and management of clinical trials. The tool computes a patient enrollment timeline in a clinical trial using multiple factors that bear on the rate of patient enrollment. The factors may be site-dependent factors or may be country-dependent factors. When these factors are applied, different sites may have different rates of enrollment in the same interval. Further, the factors may be time dependent such that even the same sites may have different enrollment rates in different intervals. Once the timeline is created, the tool may use it to calculate a schedule of monitor visits, project trial completion or otherwise generate output used in management of the clinical trial.
Claims28
A tool for clinical trial management, the tool comprising:
- computer storage media encoded with data defining:
- factors affecting patient enrollment rates during a clinical trial, the factors defining:
- non-uniform rates of patient enrollment in different time intervals of a plurality of time intervals at each of a plurality of clinical trial sites;
- and
- different rates of patient enrollment in different clinical trial sites of the plurality of clinical trial sites during the same time interval of the plurality of time intervals;
- and
- computer storage media encoded with computer executable instructions for, when executed on a processor:
- computing a patient enrollment timeline for the clinical trial, the computing comprising, using the factors, including the factors defining non-uniform rates of patient enrollment, projecting a number of patients enrolled at the plurality of sites during each of the plurality of time intervals;
- and
- providing as an output the patient enrollment time line.
A non-transitory computer storage medium encoded with computer executable instructions that, when executed by a computer, control the computer to perform a method comprising:
- computing, for each of a plurality of time intervals, a projection of a number of patients enrolled in a clinical trial, the computing comprising:
- obtaining data identifying a plurality of clinical trial sites;
- obtaining data defining non-linear patient enrollment rates at each of the plurality of clinical trial sites;
- and
- computing, using the data defining non-linear patient enrollment rates, a projected number of patients enrolled for each of the plurality of sites during each of the plurality of time intervals.
A method of operating a computer to produce an enrollment timeline for a clinical trial, the method comprising:
- computing, using a processor of the computer, a recruitment timeline, the computing comprising:
- obtaining data identifying a plurality of clinical trial sites, said data including, for each clinical trial site, a country in which the clinical trial site is located;
- obtaining data defining a plurality of factors relating to patient enrollment rates at each of the plurality of clinical trial sites, the factors comprising a country-dependent factor and a site-dependent factor;
- computing, using the plurality of factors, including the factors relating to patient enrollment rates, a projection of a number of patients enrolled for each of the plurality of sites during each of a plurality of time intervals;
- and
- outputting, as the clinical trial enrollment timeline, a projection of a number of patients enrolled in a clinical trial for each of a plurality of time intervals.
Dependencies are inferred from the claim text.