THE INFORMATION TECHNOLOGY ADVANTAGE
A clinical trial is largely dependent on the data provided by the subjects enrolled into the trial, who consume the drug under question. A drug for it to be launched in the market after extensive research takes anywhere around 15 to 20 years. Also millions of dollars are spent each year by Sponsors on clinical trials. With such a lot of effort, time and money going into trials, the success of the trial becomes very essential. This success can largely be achieved by the right data reported within the right frame of time by the patient.
Till date most trials have this data (PRO) captured by using the paper based system wherein all the questionnaires are administered by means of paper. With the modernization of the world and tremendous development of technology, time has come where all the players of the clinical research industry should use the features of information technology for improved results.
The ePRO(Electronic patient reported outcomes) and mPRO(Mobile Based Patient Reported Outcomes) provide an edge over the traditional paper based system allowing:
· Rapid data capture,
· Avoidance of data entry errors,
· Ability to trigger alerts/notifications for specific responses of concern
· Elimination of double data entry processes
· Real-time tracking of survey and compliance
· Reduction in missing information as compared to with paper administration
· Increase in patients’ willingness to report sensitive information
· Secure data storage in a compliant environment
· Easy access and storage of data -it omits the problem of data archival which is a huge problem with data storage as the regulations require the data to be stored for a minimum of 15 years after the start of the trial and 3-5 years after the drug has obtained marketing approval.
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