System and Method for Assessing Data Quality During Clinical Trials

Abstract

The present invention relates to a system and methods for facilitating the improvement of data quality generated during drug and medical device clinical trials. In one embodiment, the invention includes a system and method for generating an ideal subject suitability score for one or more interaction points of a clinical trial. One or more individual subject suitability scores may then be generated from actual subject interaction with the clinical trial for each of the interaction points of the clinical trial. For each interaction point for which an ideal subject suitability score is generated, the one or more individual subject suitability scores may be compared to the ideal subject suitability score to determine the deviation there between. The quality of data collected from actual subject interaction with the clinical trial may be a function of the difference between the individual and ideal subject suitability scores.

1 - 36 . (canceled) 
     
     
         37 . A method for assessing quality of clinical trial data generated during a clinical trial, wherein the clinical trial includes one or more clinical trial subjects that each interact with a plurality of data collection points of the clinical trial, the method comprising:
 generating, by a computer processor, an ideal data quality score for clinical trial data collected at a data collection point, wherein the data collection point comprises a point during the clinical trial at which clinical trial data for the clinical trial is collected, wherein the clinical trial is conducted according to a clinical trial protocol that includes a protocol by which the clinical trial data should be collected at the data collection point, and wherein the ideal data quality score represents a benchmark indicative of the clinical trial data having been collected in adherence to the clinical trial protocol at the data collection point;   receiving, by the computer processor, an indication of an actual procedure by which actual clinical trial data was collected during the data collection point, wherein the actual clinical trial data is associated with a clinical trial subject undergoing the clinical trial;   generating, by the processor, an individual data quality score based on one or more data factors associated with the protocol by which the clinical trial data should be collected, wherein the one or more data factors are different for different protocols by which the clinical trial data should be collected, and wherein the one or more data factors are used to determine a level of compliance with the protocol by which the clinical trial data should be collected such that the individual data quality score represents whether the actual procedure by which the actual clinical trial data was collected from the clinical trial subject at the data collection point is in adherence with the protocol by which the clinical trial data should be collected during the data collection point;   generating, by the processor, a data quality assessment based on a comparison of the individual data quality score and the ideal data quality score, the data quality assessment representative of the degree to which the protocol by which the clinical trial data should be collected was adhered to during the clinical trial; and   providing the data quality assessment to a decision maker so that the decision maker can accept or reject the clinical trial data for the clinical trial based on the data quality assessment.   
     
     
         38 . The method of  claim 37 , wherein the ideal data quality score is based on the one or more data factors. 
     
     
         39 . The method of  claim 38 , wherein the one or more data factors include data factors relevant to subject inclusion data, subject exclusion data, efficacy data, or safety data. 
     
     
         40 . The method of  claim 38 , wherein generating an ideal data quality score further comprises:
 associating a scoring system with each of the one or more data factors;   generating one or more ideal data factor scores by applying the scoring system associated with a data factor to an ideal data value of the data factor; and   determining the ideal data quality score based on the one or more ideal data factor scores.   
     
     
         41 . The method of  claim 38 , wherein generating an ideal data quality score further comprises:
 indexing the one or more data factors according to one or more characteristics;   associating a scoring system with each of the one or more data factors;   generating one or more ideal data factor scores by applying the scoring system of a data factor to an ideal data value of the data factor;   weighting the one or more ideal data factor scores; and   determining the ideal data quality score based on the weighted ideal data factor scores of the one or more data factors, wherein the ideal data quality score is determined by summing the weighted ideal data factor scores of each of the one or more data factors.   
     
     
         42 . The method of  claim 38 , wherein generating an individual data quality score further comprises:
 generating one or more actual data factor scores by applying a scoring system to each of one or more actual data values collected from the interaction of the at least one individual clinical trial subject with the data collection point, wherein the one or more actual data values correspond to actual data collected for each of the one more data factors on which the individual data quality score is based; and   determining the individual data quality score based on the one or more actual data factor scores.   
     
     
         43 . The method of  claim 38 , wherein generating an individual data quality score further comprises:
 indexing one or more actual data values according to one or more characteristics, wherein the one or more actual data values are collected from the interaction of the subject with the data collection point, and wherein the one or more actual data values correspond to actual data collected for each of the one more data factors on which the ideal data quality score is based;   generating one or more actual data factor scores by applying a scoring system to each of one or more actual data values;   weighting the one or more actual data factor scores; and   determining the individual data quality score based on the one or more weighted actual data factor scores, wherein the individual data quality score is determined by summing the one or more weighted actual data factor scores.   
     
     
         44 . The method of  claim 37 , further comprising generating one or more remedial measures to improve the data quality for the data collection point based on the data quality assessment. 
     
     
         45 . A method for assessing quality of clinical trial data generated during a clinical trial, wherein the clinical trial includes one or more clinical trial subjects that each interact with a plurality of data collection points of the clinical trial, the method comprising:
 generating, by a computer processor, an ideal data quality score for clinical trial data collected at a data collection point, wherein the data collection point comprises a point during the clinical trial at which the clinical trial data for the clinical trial is collected, wherein the clinical trial is conducted according to a clinical trial protocol that includes a protocol by which the clinical trial data should be collected at the data collection point, and wherein the ideal data quality score represents a benchmark indicative of the clinical trial data having been collected in adherence to the clinical trial protocol at the data collection point, and wherein the ideal data quality score for the data collection point is generated by:   indexing, by the processor, one or more data factors that are relevant to the data collection point, wherein the one or more data factors are different for different protocols by which the clinical trial data should be collected at the data collection point,   associating, by the processor, a scoring system with each of the one or more data factors,   generating, by the processor, one or more ideal data factor scores by applying the scoring system associated with a data factor to an ideal data value of the data factor,   weighting, by the processor, the one or more ideal data factor scores, and   determining, by the processor, the ideal data quality score based on the weighted ideal data factor scores, wherein the ideal data quality score is determined by summing the weighted ideal data factor scores of each of the one or more data factors;   generating, by the processor, an individual data quality score based on one or more data factors associated with the protocol by which the clinical trial data should be collected, wherein the one or more data factors are different for different protocols by which the clinical trial data should be collected, and wherein the one or more data factors are used to determine a level of compliance with the protocol by which the clinical trial data should be collected such that the individual data quality score represents whether the actual procedure by which the actual clinical trial data was collected from the clinical trial subject at the data collection point is in adherence with the protocol by which the clinical trial data should be collected during the data collection point, wherein the individual data quality score is generated by:   indexing, by the processor, one or more actual data values that are collected from an interaction of the clinical trial subject with the data collection point, and wherein the one or more actual data values correspond to actual data collected for each of the one or more data factors on which the ideal data quality score is based,   generating, by the processor, one or more actual data factor scores by applying the scoring system associated with each individual data factor to an actual data value of the data factor,   weighting, by the processor, the actual data factor scores according to the weighted value of their corresponding ideal data factor scores, and   determining, by the processor, the individual data quality score based on the one or more weighted actual data factor scores, wherein the individual data quality score is determined by summing the one or more weighted actual data factor scores and wherein the one or more actual data factor scores are used to determine a level of compliance with the clinical trial protocol such that the individual data quality score represents whether an actual procedure by which the clinical trial data was collected from the clinical trial subject at the data collection point is in adherence to the clinical trial protocol; and   generating, by the processor, a data quality assessment based on a comparison of the individual data quality score and the ideal data quality score, wherein the data quality assessment is representative of the degree to which the protocol by which the clinical trial data should be collected was adhered to during the clinical trial.   
     
     
         46 . A computer-implemented system that assesses quality of clinical trial data generated during a clinical trial, wherein the clinical trial includes one or more clinical trial subjects that each interact with a plurality of data collection point of the clinical trial, the system comprising:
 one or more computer processors configured to:   generate an ideal data quality score for clinical trial data collected at a data collection point, wherein the data collection point comprises a point during the clinical trial at which clinical trial data for the clinical trial is collected, wherein the clinical trial is conducted according to a clinical trial protocol that includes a protocol by which the clinical trial data should be collected at the data collection point, and wherein the ideal data quality score represents a benchmark indicative of the clinical trial data having been collected in adherence to the clinical trial protocol at the data collection point;   receive an indication of an actual procedure by which actual clinical trial data was collected during the data collection point, wherein the actual clinical trial data is associated with a clinical trial subject undergoing the clinical trial;   generate an individual data quality score based on one or more data factors associated with the protocol by which the clinical trial data should be collected, wherein the one or more data factors are different for different protocols by which the clinical trial data should be collected, and wherein the one or more data factors are used to determine a level of compliance with the protocol by which the clinical trial data should be collected such that the individual data quality score represents whether the actual procedure by which the actual clinical trial data was collected from the clinical trial subject at the data collection point is in adherence with the protocol by which the clinical trial data should be collected during the data collection point;   generate a data quality assessment based on a comparison of the individual data quality score and the ideal data quality score, the data quality assessment representative of the degree to which the protocol by which the clinical trial data should be collected was adhered to during the clinical trial; and   provide the data quality assessment to a decision maker so that the decision maker can decide whether to accept or reject the clinical trial data for the clinical trial based on the data quality assessment.   
     
     
         47 . The system of  claim 46 , wherein the ideal data quality score is based on the one or more data factors. 
     
     
         48 . The system of  claim 47 , wherein the one or more data factors include data factors relevant to subject inclusion data, subject exclusion data, efficacy data, or safety data. 
     
     
         49 . The system of  claim 47 , wherein generate an ideal data quality score comprises:
 associate a scoring system with each of the one or more data factors;   generate one or more ideal data factor scores by applying the scoring system associated with a data factor to an ideal data value of the data factor; and   determine the ideal data quality score based on the one or more ideal data factor scores.   
     
     
         50 . The system of  claim 47 , wherein generate an ideal data quality score comprises:
 index the one or more data factors according to one or more characteristics;   associate a scoring system with each of the one or more data factors;   generate one or more ideal data factor scores by applying the scoring system of a data factor to an ideal data value of the data factor;   weight the one or more ideal data factor scores; and   determine the ideal data quality score based on the weighted ideal data factor scores of the one or more data factors, wherein the ideal data quality score is determined by summing the weighted ideal data factor scores of each of the one or more data factors.   
     
     
         51 . The system of  claim 47 , wherein generate an individual data quality score comprises:
 generate one or more actual data factor scores by applying a scoring system to each of one or more actual data values collected from the interaction of the at least one individual clinical trial subject with the data collection point, wherein the one or more actual data values correspond to actual data collected for each of the one more data factors on which the individual data quality score is based; and   determine the individual data quality score based on the one or more actual data factor scores.   
     
     
         52 . The system of  claim 47 , wherein generate an individual data quality score comprises:
 index one or more actual data values according to one or more characteristics, wherein the one or more actual data values are collected from the interaction of the subject with the data collection point, and wherein the one or more actual data values correspond to actual data collected for each of the one more data factors on which the ideal data quality score is based;   generate one or more actual data factor scores by applying a scoring system to each of one or more actual data values;   weight the one or more actual data factor scores; and   
       determine the individual data quality score based on the one or more weighted actual data factor scores, wherein the individual data quality score is determined by summing the one or more weighted actual data factor scores. 
     
     
         53 . The system of  claim 46 , wherein the one or more computer processors are further configured to generate one or more remedial measures to improve the data quality for the data collection point based on the data quality assessment.