Statistics is the grammar of science – Karl Pearson
Biostatistics role and importance in clinical research started way back in the 17th century and continues to grow stronger. After helping in the work of scientific greats like Charles Darwin, Karl Parson, and others, it is now helping the budding researchers in clinical research. Biostatistics also helps in presenting the scientific manuscript with relatively sophisticated statistical analyses of a complex set of medical data in renowned scientific journals.
Biostatics in Evidence-Based Clinical Practice and Drug Development:
The biostatistical analysis is key to conduct new clinical research and one of the foundations of evidence-based clinical practice. It evaluates and applies prior research findings precisely for the new researches. With less than 10 per cent of the new compounds reaching the market, the need for advanced biostatistics is increasing every day. It is because it shortens timelines, reduces costs and risks by improving the submission quality. State of the art statistical methods now plays a key role in all the steps of the drug development process.
Biostatics Application in various fields of Clinical Research:
Clinical researches utilize biostatistics methods to provide formal accounting for sources of variability in patients’ response to treatment. Also, it allows researchers to draw reasonable and precise inferences from the gathered information to make outstanding decisions in times of uncertainty. It enables the collection, analyzing, presenting and interpreting data to find application in various field like
Biostatistics help in Clinical Researches right from its start for:
Biostatistical reasoning is characterized by:
Biostatistics prevent fraud in Clinical Research:
In recent times there have been many reports in the media glare about the frauds in the clinical trials. Biostatistics also prevents fraud or unintentional errors during clinical research. The fraud happens due to data fabrication or making up data values or falsification, which is changing data values. As per the reported cases, it involves cheating on the inclusion criteria for the ineligible persons to enter the trial. Also, by fabricating the data, the necessary data for such wrong inclusions are made not missing.
Biostatics have come on leaps and bounds with P-value:
With the continuous evolution of the biostatistical methods for the past few centuries, now they can help in experimental design with a prospective approach. The p-value which came into existence only 80 years ago has made the scope and use of biostatistics leap in bounds. P-value summarizes whether the observed data could have happened by chance and is widely used in clinical research involving:
Roles and Importance of Biostatistics in Clinical Research:
In the protocol development in clinical researches, the following are the roles and responsibilities of the biostatistician
Based on the objective of the scientific manuscript, biostatisticians have to provide a clear specification of the hypothesis to be tested. In other words, they have to provide the parameters to be tested. Also, they are responsible for selecting and defining endpoints in clinical research.
The study design of the biostatistician should provide the data needed to answer the objectives like:
It is pertinent for the LSB or the lead study biostatistician to review the full protocol for checking the following
To write randomization procedures, sample size, and analysis plan with the inputs from objectives, endpoints study design, and allocation concealment.
2. Data Management:
3. Study Implementation
It involves sampling selection and implementation of randomizes procedures
4. Study Monitoring
It involves monitoring of quality and for safety and efficacy
5. Data Analysis:
6. Reports or Manuscript writing: