¶ … Quality Standards
Data Quality Standards
This paper examines the different ways of assessing the quality of clinical trial data submitted for regulatory purposes compared to data submitted for academic publication.
Researchers and pharmaceutical firms do clinical trials for the purposes of collecting data and sharing with industry, scholars and regulators to help make policies and decisions about the efficacy/safety of illness, disease or preventative drugs being studied. To make sure that researchers are adhering to protocol and best practices in their investigations, sponsors of such studies often monitor these trials in one way or the other (Quality Management in Clinical Trials, n.d). The main objectives of monitoring are to guarantee patient safety and the integrity of the collected data. Monitoring could entail spontaneous visits during the study so as to check on the progress.
One of the most important documents in clinical trials is the CSR (Clinical Study Report). This document contains a summary of all important information related to the study. The CSR contains: researcher information, the research design, sample case report forms, statistical analyses, tables, publications and other data related to the issue being investigated. The CSR is presented to regulators...
Any questionable data is often removed from the efficacy part of the examination; to increase the reliability of the analysis, the investigators must, however, explain why the data was removed (Quality Management in Clinical Trials, n.d). The removed information may still be utilized in calculating the safety of the product. In several cases, study analyses are done with the questionable data and without it, so as to offer regulators with both analyses for deliberations. The processes used for gathering the data should be clear so as to provide regulators with insight into the ethical aspect of the study. A good quality assurance program can help ensure that risks are prevented. The Shewhart model is one of the best quality assurance guides in the market. The model's effectiveness is evident in the fact that it has been adopted by several pharmaceutical giants, including Pfizer. All across the globe, the key steps of quality assurance in clinical trials are: plan, do, check and act. This is the approach I would take to assess the quality of clinical trial data submitted for regulatory approval.
Clinical Trial Data Submitted for Academic Publications
Many firms in the pharmaceutical industry prefer restricted and voluntary clinical trials and reporting. Many drug giants…
