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The connection between biostatistics and healthcare is nothing new; in fact it is at the forefront of our industry. Biostatistics is a fundamental discipline in the modern healthcare field, as statistical methods allow us to analyze available data, explain and study diseases, and predict a range of epidemiological events. Indeed, the work done by statisticians is key in helping clinicians make decisions about the best treatment options for their patients. Let’s review the main benefits which this discipline offers for clinical research. 

 Statistical thinking will one day be as necessary a qualification for efficient citizenship as the ability to read and write. 

– H.G. Wells 

The majority of the OCT clinical team, a leading CRO in Eastern Europe, have an academic background in the fields of medicine and science. We also communicate with the researchers on a daily basis, which is why we know that no piece of research can be performed without biostatistics. Researchers and medical doctors not only apply biostatistics to analyze their data and draw conclusions, but also comb through a plethora of published articles daily in search of the latest advances in their field. Having a good understanding of basic statistical concepts such as ‘confidence intervals’, ‘correlations’, or ‘p-values’, often referred to in medical literature, is essential in order to accurately interpret the given information. It is also important to note that the incorrect application of statistical methods and the flawed interpretation of statistical results is par for the course in published medical research, even in prestigious medical journals. Being statistically literate allows readers to independently weigh the evidence, think critically and make use of reported findings with caution. 

 All models are wrong, but some are useful. 

– George Box 

Health data contain valuable insights that can be used for saving lives. That's why biostatistics is essential for data-driven decision-making, especially during large-scale health emergencies. The modern clinical researcher cannot ignore the usefulness of statistics as a critical decision-making tool in clinical research, health management and even cost-effective policy making. Biostatistics has become a cornerstone in the evolution of current evidence-based medicine, as it affects decisions related to the care of individual patients. 

 To call in the statistician after the experiment is done may be no more than asking him to perform a post-mortem examination: he may be able to say what the experiment died of. 

– Sir R.A. Fisher  

Biostatisticians have a lengthy to-do list in clinical trial projects, including planning of the clinical study design and analysis, sample size calculation, randomization schedule generation, plus interim and final statistical report preparation. At OCT, we realize that the expertise offered by our experienced and skilled biostatisticians and statistical programmers is a crucial asset to the clinical study team. Establishing communication with biostatisticians early on in the process and following up with them regularly during the clinical trial life cycle will optimize the how the study is conducted and how data is collected, with the aim being to reliably answer the research question. On the other hand, if clinicians are sufficiently well-versed in the vocabulary and fundamental concepts of statistics, they can improve their clinical judgement and help a fruitful collaboration with biostatistics experts to blossom. 

 The business of the statistician is to catalyze the scientific learning process. 

– George Box 

Biostatistics is a vast resource with endless potential to aid clinical research and drug development. No matter how long professionals have been working in this area, there is always something new to learn. While it is true that it takes a considerable amount of time for novel methods to become accepted by the regulatory authorities, and even more time until they begin to be widely implemented, we feel that there have been a lot of advances in statistical methodology in the last decade. Various types of adaptive designs, Bayesian methods, and sophisticated missing data imputation techniques have already made their way into the modern clinical trials industry. At OCT, we value innovation and are always eager to discuss the most efficient state-of-the art approaches with our clients to help achieve their goals. 

The best thing about being a statistician is that you get to play in everyone's backyard. 

– John Tukey 

When biostatisticians are assigned to a project in a new therapeutic area, they are given a very limited period of time in which to attain expert knowledge in this new field and investigate how applicable data should be correctly analyzed and reported. Depending on the project, this data might include not only different types of clinical data, such as tumor response, MRI findings, various scales and questionnaires, but also measurements related to immunogenicity, pharmacokinetics, and genetics. OCT regularly participates in studies involving the investigation of pharmacokinetics and evaluation of vaccines. Indeed, we have also been involved in exciting projects which involved performing exploratory analyses with the objective of identifying individual genetic variations and biomarkers associated with the response to the study drug in patients with rheumatoid arthritis. 

The field of biostatistics, which involves using statistics to analyze health data, plays a critical role in clinical research and the public healthcare industry. Biostatistics experts can be consulted on a variety of crucial matters and no clinical study can be successful without the proper implementation of biostatistics.  

The OCT Clinical contract research organization is well-versed in clinical study design. Our Biostatistics Department helps Sponsors successfully navigate the issues that are unique to their clinical development projects, and we adapt our CRO services accordingly.

Learn more about our biostatistics services, or contact us.