Methods and apparatus for planning and management of clinical trials

A method of executing a multi-site clinical trial, the method comprising:

• operating at least one computer processor to:
• access information identifying a plurality of trial sites;
• access trial monitoring information identifying a plurality of times when patient data is recorded and an amount of recorded patient data at each of the plurality of times;
• maintain in a computer storage medium during the clinical trial a timeline of patient enrollment in the clinical trial at each of the plurality of trial sites during each of a plurality of time intervals, wherein:
• the timeline comprises, for a first time during the clinical trial, information about actual patient enrollment in the trial in time intervals of the plurality of time intervals before the first time and projected patient enrollment in time intervals of the plurality of time intervals after the first time;
• the maintaining comprises, for a value of the first time that varies during the clinical trial, computing the projected patient enrollment by
• estimating patient enrollment in the clinical trial at each of the plurality of trial sites during each of a plurality of time intervals after the first time based on factors with values that vary among the plurality of trial sites, wherein the factors include at least one country dependent factor and at least one site dependent factor applied to compute patient enrollment at each of the plurality of trial sites during each of the plurality of time intervals, wherein the values are encoded on a non-transitory computer storage medium in a data structure relating the values to the plurality of trial sites and their associated time intervals of the plurality of time intervals;
• receiving, over at least one network from at least a portion of the plurality of trial sites during the clinical trial, information indicating actual patient enrollment during time intervals of the plurality of intervals prior to the first time;
• projecting patient enrollment in time intervals after the first time based on the actual patient enrollment during time intervals of the plurality of time intervals prior to the first time and the estimated patient enrollment at each of the plurality of trial sites in each of the plurality of time intervals after the first time;
• and
• updating, dynamically during the clinical trial, the first time and the projected patient enrollment for time intervals of the plurality of time intervals after the updated first time based, at least in part, on actual patient enrollment received over at least one network from at least a portion of the plurality of trial sites during the clinical trial;
• and
• the maintaining further comprises storing the updated projected patient enrollment in the clinical trial at each of the plurality of trial sites during each of the time intervals;
• maintain in the computer storage medium during the clinical trial a schedule of monitor visits to the plurality of trial sites, wherein:
• the schedule of monitor visits comprises timelines of when individual monitors visit the plurality of trial sites during the plurality of time intervals;
• and
• the maintaining comprises computing updates to the schedule of monitor visits by
• for each of the plurality of trial sites, computing, based on the actual patient enrollment, the updated projected patient enrollment and the trial monitoring information, a projected amount of monitor work, that a monitor will need to perform at the site, generated during second times after the first time;
• computing, based at least in part on the projected amount of monitor work at each of the plurality of sites, a projected schedule of monitor visits to be performed after the first time at each of the plurality of trial sites, wherein the schedule of monitor visits at a trial site is computed based on the projected amount of monitor work generated between monitor visits at the trial site;
• and
• updating, dynamically during the clinical trial, the schedule of monitor visits to include the projected schedule of monitor visits in the timelines of the schedule of monitor visits to reflect the updated projected patient enrollment;
• and
• the maintaining further comprises storing the updated schedule of monitor visits to the plurality of trial sites;
• and
• in response to receiving an indication to generate a report of the schedule of monitor visits, transmit, over a computer network, at least one timeline of the updated schedule of monitor visits to a device associated with a monitor of the clinical trial.

A computer system for executing a clinical trial, the computer system comprising:

• a processor;
• an output device associated with a clinical trial monitor;
• a non-transitory computer storage medium encoded with computer executable instructions, that when executed, perform a method comprising:
• maintaining a timeline of patient enrollment in the clinical trial at each of a plurality of trial sites during each of a plurality of time intervals, wherein:
• the timeline comprises, for a first time during the clinical trial, information about actual patient enrollment in the trial in time intervals of the plurality of time intervals before the first time and projected patient enrollment in time intervals of the plurality of time intervals after the first time;
• and
• the maintaining comprises, for a value of the first time that varies during the clinical trial, computing the projected patient enrollment by:
• estimating patient enrollment at each of the plurality of trial sites in each of the plurality of time intervals after the first time based on enrollment rate data and site-specific factors indicating an initiate-to-screen time and a screen-to-enroll time, wherein values for the site-specific factors are encoded in the non-transitory computer storage medium in a data structure relating the values to the plurality of trial sites and their associated time intervals of the plurality of time intervals;
• receiving, over at least one network from at least a portion of the plurality of trial sites during the clinical trial, information indicating actual patient enrollment during time intervals of the plurality of intervals prior to the first time;
• projecting patient enrollment in time intervals after the first time based on the actual patient enrollment during time intervals of the plurality of time intervals prior to the first time and the estimated patient enrollment at each of the plurality of trial sites in each of the plurality of time intervals after the first time;
• updating, dynamically during the clinical trial, the first time and the projected patient enrollment for time intervals of the plurality of time intervals after the updated first time based, at least in part, on actual patient enrollment data received from the plurality of trial sites;
• and
• the maintaining further comprises storing the updated projected patient enrollment in the clinical trial at each of the plurality of trial sites during each of the time intervals;
• accessing trial monitoring information identifying a plurality of times when patient data is recorded and an amount of recorded patient data at each of the plurality of times;
• maintaining in the computer storage medium during the clinical trial a schedule of monitor visits to the plurality of trial sites, wherein
• the schedule of monitor visits comprises timelines of when individual monitors visit the plurality of trial sites during the plurality of time intervals, wherein the schedule of monitor visits is dependent on an anticipated amount of work generated between monitor visits that monitor will need to perform at a particular trial site;
• and
• the maintaining comprises computing updates to the schedule of monitor visits by
• for each of the plurality of sites, computing, based on the actual patient enrollment, the updated projected patient enrollment and the trial monitoring information, a projected amount of monitor work that a monitor will need to perform at the site during second times after the first time;
• computing, based at least in part on the projected amount of monitor work at each of the plurality of sites, a projected schedule of monitor visits to be performed after the first time at each of the plurality of trial sites, wherein the projected schedule of monitor visits at a trial site is dependent on the projected amount of monitor work generated between monitor visits at the trial site;
• updating, dynamically during the clinical trial, the schedule of monitor visits to include the projected schedule of monitor visits in the timelines of the schedule of monitor visits to reflect the updated projected patient enrollment;
• and
• the maintaining further comprises storing the updated schedule of monitor visits to the plurality of trial sites;
• and
• in response to receiving an indication to generate a report of the schedule of monitor visits, rendering on the output device, at least one timeline of the updated schedule of monitor visits.