What is Clinical Biostatistics?

Mary McMahon
Mary McMahon

Clinical biostatistics is a facet of the sciences which involves the application of biostatistics to clinical trials. Clinical trials are designed to be scientifically rigorous so that the data generated in such trials will be meaningful, useful to other scientists, and accepted by the scientific community at large. A big part of making clinical trials successful is the application of clinical biostatistics, which play a role in everything from the early planning stages of the trial to the analysis of the data.

Clinical biostatistics is an important factor in getting approval for new drugs.
Clinical biostatistics is an important factor in getting approval for new drugs.

Clinical biostatisticians usually hold advanced degrees in biostatistics, and they may have focused specifically on clinical biostatistics in the course of their study. This field blends biology and mathematics, with people using statistical techniques to collect, interpret, and understand scientific data. Several software manufacturers have developed programs used in clinical biostatistics, with features which have been designed to meet the specific needs presented by clinical trials.

Clinical trials are a type of research done by a team of professionals with the purpose of answering a particular medical question.
Clinical trials are a type of research done by a team of professionals with the purpose of answering a particular medical question.

During the planning phases of a clinical trial, clinical biostatistics is used to develop an appropriate pool of study subjects, and to randomize trial participants for the creation of a blind study. Randomization is viewed as an important part of clinical trials because it allows researchers to compare the performance of different groups which have been randomly, rather than deliberately, created. Biostatistics software can be used to collect data once the trial gets going, and during the data analysis phase, clinical biostatistics comes into play when the evidence is interpreted and discussed.

Clinical trials are designed to be scientifically rigorous so that the data generated in such trials will be meaningful.
Clinical trials are designed to be scientifically rigorous so that the data generated in such trials will be meaningful.

Statistical analysis is an important part of clinical trials because it allows researchers to determine whether or not their results were meaningful on a statistical level. For example, anecdotal evidence from a trial with a new antibiotic might seem to suggest that the antibiotic was effective, but a statistical review of trial participants might show that the placebo was just as effective, or that there were severe side effects for so many trial participants that the antibiotic wouldn't be considered a viable treatment by the medical community.

Clinical trials are often conducted at research hospitals.
Clinical trials are often conducted at research hospitals.

Specialist firms offering biostatistics services can be used by labs to interpret their data. The use of third party analysis can validate results by ensuring that the statisticians involved are neutral parties, and it can also allow researchers to explore complex statistical models and other options which might not be available to them otherwise. Researchers can also maintain clinical biostatisticians on staff for the purpose of evaluating ongoing clinical trials. Clinical biostatistics is also sometimes used in the field of epidemiology, where a biostatistician can make sense of data which might otherwise be overwhelming.

Before drugs can be sold and marketed in the U.S., they must undergo several safety and efficacy tests -- typically on animals and humans -- called clinical trials.
Before drugs can be sold and marketed in the U.S., they must undergo several safety and efficacy tests -- typically on animals and humans -- called clinical trials.
Mary McMahon
Mary McMahon

Ever since she began contributing to the site several years ago, Mary has embraced the exciting challenge of being a wiseGEEK researcher and writer. Mary has a liberal arts degree from Goddard College and spends her free time reading, cooking, and exploring the great outdoors.

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