Research data collection and analysis

Abstract

The invention provides a method and system by which research data can be collected and analyzed during the course of the research testing, and the research testing itself possibly modified to account for conclusions drawn from the research data. In a first aspect of the invention, a research subject can respond to a protocol stored on a server by manipulating input keys on a remotely located client device onto which a research protocol has been installed. The protocol can include questions concerning the subject's physical or mental well being such as whether their symptoms are relieved or not, or even exacerbated. The protocol can also include calling for data obtained by coupling the client device with another medical device such as a glucose monitor. In a preferred embodiment, the subject is presented with narrowly structured questions and suggested answers provided by the protocol. The set of possible answers is restricted. In the event that a suggested answer is ambiguous, inapplicable or raises new questions, a protocol can present a new question to the subject. This elimination of fuzzy answers imposes a logical structure upon the subjects' assessments. In a second aspect of the invention, data entered by the subject is relayed using a communication link to a server device. This incoming data can be aggregated with other incoming data from subjects and their associated client devices. In a preferred embodiment, the data is statistically analyzed according to parameters set by the protocol. In a third aspect of the invention, a remote expert research clinician can review incoming data from either the aggregated population or from individuals as it is being analyzed. Such rapid collection and analysis allows a researcher to change the protocol in response to the trend of the data, correlate different parameters of the data so as to better identify subjects that are responding to treatment and schedule appropriate interventions as needed. The researcher can also identify specific subgroups among the population of subjects, initiate new lines of inquiry and test new sub-hypotheses that may be raised by the incoming data. This includes correlating different drug responses experienced by phenotypically similar subjects with gene expression, and other variables.

1 . A method including steps for 
 collecting data for a plurality of subjects, using at least a portion of a protocol for collecting data, wherein said protocol includes steps for receiving data from an input device;    sending data collected from said input device to a server device relatively remote from said input device;    performing a data manipulation technique on data associated with more than one of said subjects;    presenting a result of said data manipulation technique at a presentation device relatively remote from said input device;    wherein said steps for presenting occur in conjunction with repeated performance of said steps for collecting.    
     
     
         2 . A method as in  claim 1 , including steps for modifying at least a portion of said protocol in response to said result, wherein said steps for collecting are altered for at least some performances thereof.  
     
     
         3 . A method as in  claim 1 , wherein each said subject is associated with an individual input device.  
     
     
         4 . A method as in  claim 1 , wherein said data manipulation technique includes aggregating said data, combining said data, or performing a statistical operation with regard to said data.  
     
     
         5 . A method as in  claim 1 , wherein said data manipulation technique includes 
 storing said data at a device relatively remote from said input device;    receiving a data manipulation inquiry from said presentation device;    performing said data manipulation inquiry; and    presenting a result of said data manipulation inquiry at said presentation device.    
     
     
         6 . A method as in  claim 1 , wherein said data manipulation technique is specified by at least a portion of said protocol.  
     
     
         7 . A method as in  claim 1 , wherein said steps for sending data are performed in response to a time period, an event associated with said presentation device, or an event associated with said subject.  
     
     
         8 . A method as in  claim 1 , wherein at least a portion of said protocol includes presenting instructions to one said subject and receiving data from said input device in response thereto.  
     
     
         9 . A method as in  claim 8 , wherein said input device includes a keyboard, a microphone, a motion sensor, a pointing device, a set of buttons, or a switch.  
     
     
         10 . A method as in  claim 8 , wherein said input device includes a medical device.  
     
     
         11 . A method as in  claim 1 , wherein at least a portion of said protocol includes presenting questions to one said subject and receiving answers from said subject in response thereto.  
     
     
         12 . A method as in  claim 11 , wherein said operation of presenting questions includes presenting structured answers and said operation of receiving answers includes receiving a selection from a set of restricted possible answers.  
     
     
         13 . A method as in  claim 1 , wherein at least a portion of said protocol is performed at a client device located relatively proximate to said input device.  
     
     
         14 . A method as in claim,  13 , wherein said portion is altered at said client device in response to said presentation device.  
     
     
         15 . A method as in  claim 13 , wherein said portion is received by said client device in response to said server device.  
     
     
         16 . A method as in  claim 1 , including steps for 
 providing a second protocol;    selecting a portion of said plurality of subjects in response to said data manipulation technique; and    altering said steps for collecting data to perform said one protocol for unselected ones of said subjects, and to perform said second protocol for selected ones of said subjects;    wherein said steps for collecting are altered for at least some performances thereof.    
     
     
         17 . A method as in  claim 16 , wherein said steps for selecting are performed in response to a genotype, a gene expression, or a phenotype of one or more of said subjects.  
     
     
         18 . Apparatus including 
 an input device disposed for coupling to a subject, said input device including a processor for performing at least a portion of a protocol for receiving data from said subject;    a server device relatively remote from said input device;    a communication link between said input device and said server device;    a processor including software for performing a data manipulation technique on data associated with more than one of said subjects;    a presentation device relatively remote from said input device, coupled to said processor, said presentation device disposed for presenting a result of said data manipulation technique;    wherein said steps for presenting occur in conjunction with repeated performance of said steps for collecting.    
     
     
         19 . Apparatus as in  claim 18 , including a message modifying at least a portion of said protocol in response to said result, wherein said steps for collecting are altered for at least some performances thereof.  
     
     
         20 . Apparatus as in  claim 18 , wherein said input device includes a keyboard, a microphone, a motion sensor, a pointing device, a set of buttons, or a switch.  
     
     
         21 . Apparatus as in  claim 18 , wherein said input device includes a medical device.