The importance and role of biostatistic in clinical Research trials

The Importance and Role of Biostatistic in Clinical Research

Biostatistic In Clinical Research

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 Presentating the Scientific Manuscript with relatively sophisticated statistical analysis of a complex set of medical data in renowned in Scientific Journal

Biostatistic In Clinical Research

Biostatistic In Clinical Research

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.

Biostatistic In Clinical Research

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.

Biostatistic In Clinical Research

Biostatics Application in various fields of Clinical Research: It enables the collection, analyzing, presenting and interpreting data to find application in various field like • Epidemiology • Clinical trials • Population genetics • Systems biology

Biostatistic In Clinical Research

Biostatistics help in Clinical Researches right from its start for: • Designing • Conducting • Analyzing • Reporting • Minimizing biases • Confounding factors

Biostatistic In Clinical Research

Biostatistics help in Clinical Researches right from its start for: • Measuring random errors • Understanding the research • Make suggestions on hypothesis testing & analysis • Calculating the sample size • Determine the power of the study • Ensure continuity throughout the research

Biostatistic In Clinical Research

Biostatistical reasoning is characterized by: • Establishes an objective framework to conduct investigations • Places both data and theory on an equal scientific footing • Data production is designed through experimentation • Quantifies the influence of chance • Estimates systematic and random effects • Combines theory and data by way of formal methods

Biostatistic In Clinical Research

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 ineligible persons to enter the trial

Biostatistic In Clinical Research

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 pvalue which came into existence only 80 years ago has made the scope and use of biostatistics leap in bounds. Pvalue summarizes whether the observed data could have happened by chance and is widely used in clinical research involving

Biostatistic In Clinical Research

• Investigating proposed medical treatments • Assessing the relative benefits of competing therapies • Establishing optimal treatment combinations Roles and Importance of Biostatistics in Clinical Research: 1. Protocol Development In the protocol development in clinical researches, the following are the roles and responsibilities of the biostatistician

Biostatistic In Clinical Research

2. Data Management: 3. CRF management with content and design 4. Dataset specification with annotation of CRFs and record layout 5. Validation with error checking specification and test data 3. Study implementation: It involves sampling selection and implementation of randomizes procedures

Biostatistic In Clinical Research

5. Data Analysis: • A detailed analysis plan writing with all hypotheses to be tested along with the hierarchy of analysis • It helps to prepare for reporting, manuscript writing, along with the validity and creditability of results 6. Reports or Manuscript Writing: • Method section with statistical methodology and description of data with endpoints and design

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