Medical Animation and Communication

Clinical trials are studies conducted to test the pharmacokinetics, pharmacodynamics, safety and efficacy of a drug. A lot of resources are utilized to conduct the study across multiple clinical sites. These sites produce the safety and efficacy data which are then submitted to a regulator for getting approval. The regulator reviews this data and awards the sponsor with drug approval if the data are found to be adequate. The data provided to the regulator must be quality data (i.e., consistent, reliable and related to the drug) to achieve drug approval. If inconsistent and incomplete data are submitted to the regulators, the regulators will raise the number of queries and will not provide the approval to the drug. That is why monitoring practices are essential to ensure data quality. Traditionally, source data verification is often used by sponsors to manage the quality of trial data. However, recent studies prove that source data verification cannot ensure the quality of data. An addendum ICH-E6-R2 to this original document ICH-E6-R1 has been published on 1st March 2018 which has implemented a number of changes throughout the document. There is also a new info for the use of a statistical approach which has defined the role of statistics in improving the quality of data in a clinical study. Addendum ICH-E6-R2 favors the Centralized Monitoring that helps in differentiating reliable and potentially unreliable data. To enhance the data quality in clinical trials, there is another combination approach, i.e., Centralized Statistical Monitoring which is a combination of Centralized Monitoring and Statistical Monitoring. . By utilizing Centralized Statistical Monitoring to analyze the clinical trial data, quality data can be generated.