Biostatistics in Clinical Trials

Crunching numbers might seem like the least fun part of a clinical trial, but it is the most important!

Now, considering the amount of data that is compiled in a clinical trial, analyzing it can be as complicated as the trial process itself. If not tailored according to a precisely defined data range, trial results can be inaccurate or even misleading.

There are many challenges in data analytics. For example, if patients’ responses to treatment significantly diverge from the expected, it can threaten the desirable outcomes. Furthermore, analyzing trial data can be corrupted with bias, confounding factors, and random errors.

Luckily, modern clinical work overcomes these issues with the use of back-end biostatistics.

In contrast to the general opinion, statistical methods are not applied only to the final data analysis. In fact, biostatistics plays a significant role in clinical trials, from the initial study design to the final analysis report.

The Importance of Biostatistics

Biostatistics is an integral part of modern-day medical research. Its methods are applicable to a wide range of study areas, such as epidemiology research, randomized trials, population genetics, and more.

More importantly, statistical methods are vital in all steps of the drug and medical device development process. They are applied in collecting, analyzing, presenting, and interpreting of trial data.

The use of statistics allows the researcher to form rational inferences from the collected data. It facilitates making sound decisions in the presence of uncertainty, while at the same time eliminating data corruption.

When employed early in the process, biostatistics ensures continuity throughout the research and caters to the statistical significance of the results. By improving the final submission quality, it reduces costs and risks while shortening the total trial timeline.

Therefore, it is highly recommended that trial operators include a biostatistician throughout the whole process of a trial.

The Roles of Biostatistics in a Clinical Trial

The best time to include a biostatistician in clinical trials is at the very beginning. This way, he will understand the trial design and could make suggestions early on in the process.

1. Protocol Development and Study Design

In protocol development, biostatisticians provide a precise specification of the hypothesis that is to be tested. That is, they define the test parameters and study endpoints.

Statisticians can be included even in the study design, to define the procedures to minimize the selection bias. For example, in randomized trials, they define the randomization procedures, including sequence generation and frequency of contacts.

One of the most critical roles of a biostatistician is determining the p-value. P-value is a viability factor that summarizes whether the observed data could have happened by chance. It is used for

  • Calculating the effective probability when investigating new medical treatment,
  • Assessing the prime benefits of competing therapy choices, and
  • Establishing optimal treatment combinations.

Biostatisticians could be consulted to create study assumptions based on the available historical data on the topic, and statistically justify it in terms of feasibility. By calculating the sample size, they justify the primary endpoint in terms of precision and study power.

Biostatistics is also used in the analysis plan summary in which the achieving of the trial objectives is assured.

Statistical analysis plan (SAP) defines the statistical methodology for assessing the primary objectives, such as testing procedures and statistical hypotheses.

Biostatisticians can also write and review the protocol while ensuring clarity, consistency, completeness, data quality preferences, and feasibility.

2. Data Management

Biostatistics is used in CRF management to assure dataset specifications and to validate errors.

3. Study Implementation

A biostatistician could be consulted to monitor sampling selection and implementation of randomized procedures.

4. Study Monitoring

Biostatistics is used to monitor quality and the safety of data and efficacy of the process.

5. Data Analysis

A biostatistician assures that all hypotheses are accurately tested along with the hierarchy of the analysis. This way, he vouches for validity, credibility, and statistical significance of the results.

6. Writing of the Final Report

Biostatisticians write the final Statistical Analysis Report – trial document that assures data accuracy and the significance of the results. Biostatisticians are responsible for creating Tables, Lists, and Figures within the final report.

Additionally, biostatistician can be employed in writing final study sections, such as:

  • Method section (statistical methodology and description of data with endpoints and design),
  • Result section (data presented in the form of a graph, tables, and others),
  • Discussion section (the appropriate interpretation of the results).

The Bottom Line

Biostatisticians are integral members of clinical trials, providing valuable insight into the whole trial process. From the development of a trial protocol to the final analysis report, biostatistical calculations lead the way of better understanding causality and optimizing outcomes.

The appropriate use of biostatistics prevents fraud and even unintentional errors in clinical research by postulating conditions of eligibility of patients to enter the trial and meticulously analyzing data on the go.

In the ever-changing clinical trial landscape, saving time and improving trial accuracy is of prime importance. The use of biostatistics expedites the process and assures overall data significance.

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