Development and Implementation of Biostatistical Collaboration in the Clinical Research Field 


Biostatistics Definition 

When we talk about statistics, data analysis, averages, population and like words come to our mind. Morphing biology into the equation, biostatistics will emerge as the birthchild of those two fields. 

Accordingly, biostatistics is the application of statistical principles to questions and problems in medicine, public health or biology. This is a definition encapsulating the idea of biostatistics being a field that overlaps with other fields. 


Biostatistics for Clinical trials 

Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. This is accomplished through clinical trials. 

There are several methods of utilizing the knowledge of biostatistics in research, but one of the most interesting use cases is medicine. A particular medical application of biostatistics is in clinical trials. 


Role of Biostatistics in Clinical Research Stages 

The biostatistical analysis key to conduct new clinical research. It evaluates and applies prior research findings precisely for the new researches. Accordingly, it helps biotechnology and pharmaceutical companies designing and analyzing clinical trials.  

Biostatisticians play an important role to support the researchers at any stage of their clinical research whether it was in the protocol development, data management, data analysis, reporting or manuscript writing.  



The protocol development stage 

In this stage, Biostatisticians determine the power/precision of the primary endpoint, calculate the appropriate sample size, define randomization procedures for treatment/group allocation if applicable, specify clearly the tested hypotheses/parameters as well as the analysis strategy (FAS, per-protocol, intention-to-treat, ...).

Moreover, they describe statistical tests and methods alongside their justification and their thresholds of significance, as well as the imputation methods for missing data. They also specify the statistical software(s) with the number and time of planned interim analyses. 


The data management stage 

In the data management activities, biostatisticians support the design of case report form to facilitate and ensure an appropriate data collection answering the research questions. In addition, they provide database structure input to avoid complexity, and limit inconsistencies. They participate in database structure testing to check the accuracy and validity of database. 

Before database lock, they can review the database to detect any remaining inconsistencies before data analysis to ensure the highest quality of data. 


The data analysis stage 

In this stage, biostatisticians follow the statistical analysis plan (SAP) that was created and approved during the early stage of clinical research. Statistical analysis plan includes a detailed description of statistical methods and statistical software to be used, as well as analyses and graphs of the data. 

After completion of all required analyses, they prepare the statistical analysis report including all results with interpretation in different formats like tables, graphs and other visualizations.