Clinical Data Management and Biostatisticians

In clinical research, a tool called clinical data management system (CDMS) is used to handle the data of a clinical trial. The data will be gathered from the investigator in case report form, which are then stored in the CDMS. Proper storage and good management of these data are vital in the pharmaceutical industry in order to provide high quality and reliability of the data results. The reason why quality is of essence in this industry is because poor quality will mean a postponement in the development of drug and introduction to the market, which will eventually bring about huge loss to the pharmaceutical companies.

For these reasons, the fifth session introduced us to clinical data management. Although I could not attend the session because I need to attend research field trip briefing at university, I took the initiative to study this topic by myself and obtained information online.

I learned that to produce quality clinical data management and to ensure process improvements, ongoing quality checks which draw attention to the probability of error estimation and error minimization should be carried out. Full commitment should be made by institutions and organizations when handling clinical data to ensure data are stored appropriately and suitably for later use. Nevertheless, this is not always the case as it could be relatively costly to do systematic curation as it not only involves carrying out good and reproducible science, but also about integrating the data from various sources and applying them in novel ways.

When reaches the end of the clinical trial, data collected in the CDMS has to be sent to the statisticians to analyze the data before sending to the regulatory authorities for approval. This is when biostatisticians come into the picture of clinical research. Biostatisticians play a significant role in phase I trial to permit clinical researchers to produce accurate inferences from acquired data and to deduce sound decisions when uncertainty is present. Statistical planning as well as analysis which are done with high accuracy will ensure that the reporting and documentations are delivered with high-quality. Because of the importance of biostatisticians in clinical research, guidelines by the Royal Statistical Society have been set up.

In a nutshell, the field of clinical research require cooperation from many parties and organizations to ensure a high-quality finishing result. I really glad I am part of this BeST programme which covers not only biotechnology field but clinical research field to provide insight in this rapidly expanding field, which will generate plenty of exciting opportunities for the trained professionals.