Developing Protocols and Procedures for Clinical Trial Data Integrity
Bhaswat Chakraborty,
Senior Vice President & Chairman,
Cadila Pharmaceuticals
Outcome and interpretation of clinical trials, whether for regulatory or non-regulatory purposes, are as good as the accuracy and quality of their data. Thus a proper planning and protocol for collecting “true data” must be developed for all clinical trials. Three distinct areas of data integrity processes and protocols ensure collecting and analyzing true data: data collection protocols, monitoring protocols and data integrity protocols. Remote data capture is one example of improving the integrity of collected data. Monitoring would cover plans designed by the PI or the CRO to ensure adherence to data collection protocols or a database management system for data integrity of small- to medium-size, low risk trials. Approaches like interim analyses (IA) for assessing integrity and possible final outcome can be implemented by the directives of an established DSMB for a complex and/or high risk, large Phase III, multicenter, clinical trial. In all these areas, proper training is necessary to achieve the data integrity goals. The speaker will elaborate these data integrity approaches with fitting examples.
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