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May 25, 2022 Regulatory Sciences

How Important is Biostatistics?

The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded in recent years.

Biostatisticians play a key role in the public health landscape, allowing scientists to support decisions made about patient care and better focus medical research, and to make sense of all of that available data.

It is important to understand the science and statistical principles behind the decision-making, and how important biostatistics is to the efficacy and efficiency of healthcare delivery and patient care.

What is Biostatistics?

Biostatistics is a field of study that links statistics and biology, using traditional statistical techniques applied to public health and clinical trials. Biostatisticians are the experts behind the science, making connections – or finding a lack thereof – to determine, for example, whether an identified treatment is safe and effective.

Put simply, biostatisticians turn available public health and clinical trial data into usable knowledge.

What Is the Importance of Biostatistics in Clinical Research?

It is through the use of biostatistics that clinical researchers are able to draw inferences from gathered information. Biostatistics touches clinical research in a number of ways as part of a collaborative process from start to finish, including but not limited to the areas below.

Development and Design of Clinical Research Frameworks

In an ideal scenario, biostatisticians are called into clinical research studies at the very beginning, to support the clinical development team by providing input into study objectives, methods of data analysis, and overall study design to improve study outcomes. A key component of study design, for example, is the study’s sample size, an area of expertise for any biostatistician. A sample size that is too small will result in an underpowered study that can draw no meaningful conclusions, while a sample size that is too large can be wasteful in both cost and time.

Data Monitoring & Management

Biostatisticians support the creation of data management plans and identify areas of potential weakness in data collection. This in turn supports a high level of validity in data collection and analysis.  A clinical study can only be as good as the quality of its data and the biostatistician aids in the collection and cleaning of this data to ensure the highest quality possible.

Data Analysis & Reporting

Biostatisticians design and create a statistical methods plan with a description of the statistical methodology to be used, and which analyses and visual representations of the data (e.g. graphs or tables) will be used. Then the biostatistician oversees the execution of this plan once all the study data has been collected.

Use Cases for Biostatistics

Biostatistics links life sciences data and statistics to inform a number of areas in healthcare and medicine. If there is clinical data or health related data, the biostatistician can help analyze and summarize this data.

Clinical Trials

Clinical trials looking to measure patient outcomes based on new treatments or diagnostic methods are crafted with biostatistics in mind. As described above in relation to clinical research, biostatisticians work behind the scenes to design clinical trials that allow for highly valid data collection, analysis and summarization methods. Clinical trials are behind advances in everything from the efficacy of new drugs on the market to analyses of clinical interventions affecting the public health to vaccines for the prevention of disease.

Epidemiological Studies

Advances in epidemiology, the backbone of preventative care and a key component in public health policies on a broad level, are supported by data analyzed by biostatisticians. It is biostatistics that looks at the links between the cause and effects of diseases, or the factors that contribute to a wider spread of disease. Biostatistics can also point to a lack of a link between hypothetical causes of a disease, allowing researchers to move their focus forward and eliminate risk factors.

Improving Patient Care

Biostatistics on a more local level can also be used to improve patient care. Statistics gleaned from available studies can be analyzed and then used to craft more efficient healthcare systems, or individualized patient plans to improve outcomes for those patients. Data- and evidence-based decisions take bias out of the equation in a healthcare system as well, reducing the risk of ineffective treatments and inefficient patient care.

Trends in Data

Biostatistics does not always mean the scientific analysis of fresh data. It can also mean meta-analysis of the wealth of data that already exists. Examining medical research around a particular disease, for example, can lead to statistical trends around common risk factors, expected lifespans, and the potential for any environmental or genetic factors. This kind of statistical information and trends in data can then be used to point to potential treatment methods to support patient outcomes.

The Future of Biostatistics

The application of biostatistics in healthcare continues to grow, as do innovations in the field. Wherever data-driven decisions can:

  • Lead to improved patient outcomes and healthcare efficiency
  • Boost the efficacy of healthcare programs
  • Support overall public health and related policies

The importance of biostatistics is only more obvious.

ProPharma Group is a leader in clinical research solutions, with services that include biostatistics. Contact us to find out how our experts can help ensure that your statistical analysis is not only valid and complete, but also supported by the data and presented in a way that is easy to understand. Improve your data collection and analysis with ProPharma Group.

Interested in learning more? Contact us today to find out how we can help not only with your EMA/FDA submissions, but all of your global regulatory needs.

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