Clinical trial data management : preserving source data
To accelerate clinical processes and information sharing, electronic tools have taken an ever-expanding role in clinical trial management over the past 15 years.These tools offer stunning performances in fulfilling the needs of clinical and data management teams. However, they also raise data validity issues in certain usage situations. The Patient Reported Outcomes (PRO) issue is an interesting illustration of this. All the studies show that PROs conducted using plain paper generate a high ratio of unreliable data (more than 30%). To deal with this point, a number of electronic solutions have been developed to improve data quality and compliance with the protocol. However, the FDA has found (see December 2009 document attached, in particular p. 26) that feedback from strictly electronic data provided directly by patients raises a major issue in that it does not offer matching source data. While electronic data entered by an investigator can be checked against the patient’s file, electronic data collected “via keyboard” by the patient himself cannot be matched against any source data. Kayentis solutions combine reliability (timestamping) and fast transmission of electronic data with the preservation of matching source data (the patient diary that is returned to and kept by the investigator). This makes patient data fully reliable, and it can be consulted by the sponsor or the supervisory authority. |
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