ROLE OF BIOSTATISTICS IN CLINICAL TRIALS

 


Role of biostatistics in clinical trials | Cromos Pharma


INTRODUCTION

 Biostatistics is the application of statistical principles to questions and problems in medicine, public health, or biology," says Lisa Sullivan from the Boston University School of Public Health. This definition captures the idea that biostatistics is an interdisciplinary field. Biostatistics is essential to the process of developing new drugs, from trial design to protocol creation. Numerous disciplines, including population genetics, clinical trials, systems biology, and others use biostatistics.

To gather, evaluate, present, and understand data for clinical research, biostatistics is essential. It aids in making decisions about the safety and effectiveness of a medication, course of treatment, or therapy.Every stage of clinical research, including trial design, protocol creation, data management and monitoring, data analysis, and clinical trial reporting, involves the use of biostatistics. In order to achieve successful trial design and analytics, clinical operations staff and statisticians should work well together.Additionally, biostatistics aids in the presentation of the scientific publication in prestigious scientific journals with reasonably advanced statistical analyses of a complex set of medical data.


KEY TERMINOLOGIES OF BIOSTATISTICS:

  • Population: the entire group studied (e.g., every male in Germany)

  • Sample: a subgroup from the population (e.g., 25-45-year-old males in Germany)

  • Sample size: number of participants or objects in a sample

  • Relative risk: ratio of the risk of an event to an exposed group compared to a non-exposed group

  • Hypothesis: a statement that tries to explain the relationship of two or more variables


ROLE OF BIOSTATISTICS IN CLINICAL TRIAL

       The creation of novel pharmaceuticals and medical treatments depends heavily on     biostatistics in clinical trials. Prior to being made available to the general public, clinical trials are the cornerstone for assessing the efficacy and safety of proposed medicines. Biostatisticians are entrusted with a big task in this area. They manage the design, analysis, and interpretation of the trial results, which is a difficult and time-consuming task. Their diligent efforts to prepare the study for submission to regulatory bodies are crucial to the overall study's success.

  • Study Design Development: The techniques and focus of the research to be conducted can be determined by biostatistics.

  • Consolidating the Evidence: Biostatistics techniques can effectively sort a large amount of data.

  • Data Analysis: not only does data need to be organized, but it also needs to be analyzed to draw insights that could prove or disprove a particular hypothesis

  • Interpretation: Because biostatisticians involved in clinical trials possess specialized knowledge, they can assist in offering interpretations of the experiment's findings

KEY RESPONSIBILITIES DURING THE CLINICAL  TRIAL

     Starting with the early planning and design stages, biostatisticians play a crucial role at 

various stages of a clinical study. Significant contributions from biostatisticians are made to the ongoing assessment of the clinical study. 


They take on the important responsibility of delivering safety analyses to the Data and Safety Monitoring Board (DSMB), a governing body in charge of monitoring the safety of the trial.

The biostatistician will undertake quality control checks to detect data outliers and guarantee data accuracy at the conclusion of the study once the data management team has finished collecting the data to ensure that the data is accurate, of high quality, and free of mistakes or inconsistencies.Additionally, throughout the course of the experiment, biostatisticians are actively involved in carrying out interim analyses. These analyses have several functions, including identifying the sample size's suitability, analysing the safety and effectiveness of the treatment, and monitoring the trial's progress. Biostatisticians can discover potential patterns, quantify treatment effect, and decide whether any adjustments or revisions are required by reviewing the accumulating data at interim time points.

1. Planning and design phase

The clinical research team and the team of biostatisticians collaborate closely to develop the goals, measures, and hypotheses of the study. They identify the statistical problems that might have an impact on the study's design and choose the right sample size. Biostatisticians determine the bare minimum of participants required to identify a clinically significant difference between the treatment and control groups using statistical power calculations. A sample size that is too small can lead to an underpowered study, whereas a sample size that is too large can be ineffective and expensive.

2. Randomization and blinding

The crucial task of creating complex randomization and blinding processes for the clinical study falls to biostatisticians. The difficulty is in carefully analyzing each "randomization list" parameter. Randomization ensures an unbiased allocation of participants across treatment and control groups.

Similarly, blinding procedures play a pivotal role in maintaining the integrity of the trial by ensuring that both participants and investigators remain unaware of the treatment assignments. 

This safeguards against potential bias and ensures that the observed outcomes truly reflect the efficacy and safety of the intervention being tested.

PRODUCING CLINICAL STUDY REPORT

       One of the crucial responsibilities of a biostatistician is the production of CSR.They are in charge of performing the proper statistical analysis to assess the trial's results, efficacy, and safety precautions. Biostatisticians are essential to accurately and succinctly evaluating and summarising the statistical results in the CSR. They make sure that the data analysis is sound, the statistical methods are proper, and the results are presented in a way that is clear and intelligible.

The clinical research team and biostatisticians work closely together to ensure that the CSR appropriately reflects the study's design, goals, and results. They offer knowledge in data interpretation and aid in validating the findings to make sure they are in line with the goals and objectives of the study. Biostatisticians are essential to the development of a thorough and well-documented CSR since their work has a big impact on how regulatory agencies assess the effectiveness and safety of the treatment.

 CONCLUSION:

 Biostatistics in clinical trials plays a crucial role in the development of new drugs and

 medical treatments. They engage in complex and time-consuming work, overseeing the

 design, analysis, and interpretation of the trial data. The success of the entire study hinge  

 on their meticulous efforts pave the way for the submission to regulatory bodies.

REFERENCES:


Student Name: A.Sravani

Student ID:160/082023

Qualification: B.Pharmacy

e-Mail ID: sravaniapuri516@gmail.com



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