System and Method for Monitoring Clinical Trial Progress
A method for monitoring clinical trial progress includes calculating progress curves for clinical trial states. Calculating a progress curve includes assigning values to events for a datapoint in the clinical trial, generating or building pairs of values for each consecutive sequence of the events, summing up the values of pairs of events corresponding to a state change, and determining a state for the datapoint based on the sum of the values. Monitoring clinical trial progress then includes calculating a second progress curve for another clinical trial state and comparing the delay between points of the progress curves. A system for monitoring clinical trial progress is also described.
1 . A method for calculating a progress curve for a clinical trial state, comprising:
assigning values to events for a datapoint in the clinical trial;
generating pairs of values for each consecutive sequence of the events;
summing up the values of pairs of events corresponding to a state change; and
determining a state for the datapoint based on the sum of the values.
2 . The method of claim 1 , further comprising determining a state for a plurality of datapoints in a datapage.
3 . The method of claim 2 , further comprising determining a state for the datapage based on the states of the plurality of datapoints in the datapage.
4 . The method of claim 1 , further comprising calculating a first state curve based on the time when the first datapoint reaches said state.
5 . The method of claim 1 , further comprising calculating a current state curve based on the time when the last datapoint reaches said state.
6 . A system for monitoring progress of a clinical trial, comprising:
a data collector including a processor for collecting data from at least one clinical trial database and for producing current statuses of the trial and historical audits;
an historical statuses reconstructer including a processor for converting the current statuses and historical audits to generate aggregated tracking data;
a progress curve generator including a processor for converting the aggregated tracking data to calculate a first progress curve for a first state of the clinical trial over a time period and a second progress curve for a second state of the clinical trial over the same time period; and
a progress tracking service for transmitting first and second progress curves to a user,
wherein the progress curve for a state comprises an amount of datapages within that state.
7 . (canceled)
8 . The system of claim 6 , wherein a datapage is considered within a state when all of the datapoints in the datapage are within that state.
9 . The system of claim 6 , wherein the progress tracking service compares the delay between points of the first progress curve and the second progress curve.
10 . The system of claim 6 , wherein the progress tracking service compares the completion between the first progress curve and the second progress curve.
11 . A method for monitoring progress of a clinical trial, comprising:
calculating a first progress curve for a first state of the clinical trial over a time period;
calculating a second progress curve for a second state of the clinical trial over the same time period; and
comparing the delay between points of the first progress curve and the second progress curve to assess the quality of the clinical trial,
wherein:
the progress curve for a state comprises an amount of datapages within that state; and
a datapage is considered within a state when all of the datapoints in the datapage are within that state.
12 . The method of claim 11 , wherein the first and second states are selected from data entered, verified, and locked.
13 . The method of claim 11 , further comprising comparing the completion between the first progress curve and the second progress curve.
14 . The method of claim 11 , wherein the first progress curve is calculated by:
assigning values to events for a datapoint in the clinical trial;
generating pairs of values for each consecutive sequence of the events;
summing up the values of pairs of events corresponding to a state change;
determining a state for the datapoint based on the sum of the values; and
determining a state for a datapage comprising a plurality of datapoints based on the states of the plurality of datapoints.
15 . A method for monitoring progress of a clinical trial, comprising:
calculating a progress curve for a state of the clinical trial over a time period;
accessing a performance profile for clinical trial progress; and
comparing the progress curve to benchmarks in the performance profile.
16 . The method of claim 15 , wherein the performance profile comprises historical information.
17 . The method of claim 15 , wherein the performance profile comprises a combination of historical information and information from the clinical trial.
18 . The method of claim 15 , wherein the progress curve is calculated by:
assigning values to events for a datapoint in the clinical trial;
generating pairs of values for each consecutive sequence of the events;
summing up the values of pairs of events corresponding to a state change;
determining a state for the datapoint based on the sum of the values; and
determining a state for a datapage comprising a plurality of datapoints based on the states of the plurality of datapoints.