What are the roles of biostatistics in clinical research?
Many students studying medicine find it unnecessary in their initial years of study to learn statistics. But the reality is many profound doctors feel the need biostatistics since in the time of their study it was not in the medical study curriculum. The doctors need to study biostatistics not only for researchers but also to enhance their reading capability of medical literature. Only with the introduction of evidence-based medicines as a cornerstone for medical management, biostatistics came into vital prevalence.
What is clinical research?
All systematic researches carried out on human beings to generate data for discovering or verifying the pharmacological, clinical or adverse effects with the objective of determining efficacy and safety of the new drug are called clinical researches. They bring in the following benefits to humankind:
- Assess the relative benefits of competing therapies
- Investigating proposed medical treatments
- Establishing optimal treatment combinations
- Improving knowledge of disease
- Developing diagnostic methods
- New treatments & medical devices
The role of biostatistics in clinical research methodology:
Guidelines of evidence-based medicine are squarely depended on meta-analysis. It is, in turn, is based on many randomized controlled clinical types of research. Only this will provide rock-solid evidence to help doctors in making decisions on the best management options for patients. A firm understanding of statistical methods only will facilitate the understanding of the randomized clinical research methods and results. Hence biostatistics plays an important role in evidence-based medicine, which is the base for doctors to recommend treatments for patients now.
The other roles of biostatistics in clinical research:
- It is crucial for any clinical research from design, conduct, analysis, and reporting in terms of controlling and minimizing biases, confounding factors, and measuring random errors.
- They provide formal accounting for sources of variability n patients’ response to treatment.
- It helps the clinical researcher to form reasonable and precise inferences from all collected information to make the correct decisions during the presence of uncertainty.
- Since clinical research is critical for a new drug for its efficacy, it is helped by biostatistics in drug development. It helps in the following areas:
- Protocol & study design (e.g. randomized trials)
- Data management
- Sample size calculation for dose response studies, microarray studies and Bayesian approaches
- Misclassification
- Effect modification
- confounding
- Study implementation
- Study monitoring for safety and efficacy
- Data analysis
- Data reporting
Biostatistician support is essential for the hypothesis of clinical researches based on the observed data and the theoretical statistical model for evidence-based medicine and treatments.