Clinical studies

Expertise in Clinical Trials

At Epistat, we specialize in providing expert statistical consulting services for clinical trials. With many years of experience in the field, our mission is to support researchers and pharmaceutical companies in designing, analyzing, and interpreting clinical data to advance medical research and improve patient outcomes.

Our Services Include:

Study Design: Tailoring clinical trial designs to meet regulatory requirements and scientific objectives.
Data Analysis: Employing advanced statistical methods to ensure robust and reliable results.
Regulatory Submission: Preparing statistical sections for regulatory submissions to ensure compliance with guidelines.
Interim Analysis: Conducting interim analyses to assess trial progress and make informed decisions.
Reporting: Providing comprehensive reports and visualizations to clearly communicate findings.

Why Choose Us?

Expertise: Extensive experience in various phases of clinical trials, from early-phase studies to late-phase trials and programs.
Quality: Commitment to delivering high-quality, accurate, and timely results.
Collaboration: Working closely with clients to understand their unique needs and challenges.
Innovation: Utilizing the latest statistical techniques and software to stay at the forefront of the field.

About Us

Epistat is led by Anders Berglund, a seasoned statistical consultant with a proven track record in the field of clinical trials. Our dedicated team brings a wealth of knowledge and a passion for excellence, ensuring that your clinical trial data is expertly handled and interpreted.

Contact us today to discover how we can support your clinical trials and help you achieve your research objectives with confidence.

Biostatistics in clinical trials

Biostatistics plays a crucial role in clinical studies by providing the tools and methods necessary to design, analyze, and interpret data. Here's why biostatistics is indispensable in clinical research:

1. Study Design and Planning
Biostatistics helps in designing robust and efficient clinical studies. This includes determining the sample size, selecting appropriate study designs (e.g., randomized controlled trials, cohort studies), and defining endpoints. A well-designed study increases the likelihood of obtaining valid and reliable results.

Example: Determining the sample size ensures that the study has enough power to detect a clinically significant effect, thereby avoiding both underpowered studies that cannot detect differences and overpowered studies that waste resources.

2. Data Analysis and Interpretation
Biostatistics provides the methods to analyze complex data sets, allowing researchers to make sense of the data collected. This includes choosing the right statistical tests, managing data variability, and accounting for confounding factors.

Example: In a clinical trial comparing two treatments, biostatistics is used to determine whether observed differences in outcomes are statistically significant or could have occurred by chance.

3. Ensuring Validity and Reliability
Biostatistical methods help ensure the validity (accuracy) and reliability (consistency) of study results. This involves controlling for biases, handling missing data appropriately, and using correct methods to analyze longitudinal data.

Example: Using techniques like randomization and blinding helps reduce selection and information bias, thereby increasing the validity of the study conclusions.

4. Handling Data Complexity
Clinical studies often involve complex and large datasets. Biostatistics provides tools for managing and analyzing this complexity, including multivariate analysis, survival analysis, and Bayesian methods.

Example: Survival analysis techniques, such as Kaplan-Meier curves and Cox proportional hazards models, are essential for studying time-to-event data, such as the time until disease progression or death.

5. Interpreting Clinical Significance
Biostatistics helps distinguish between statistical significance and clinical significance. This ensures that the findings are not only statistically sound but also meaningful and relevant for patient care.

Example: A statistically significant difference in blood pressure reduction might not be clinically significant if the reduction is too small to impact patient outcomes.

6. Regulatory Compliance and Reporting
Regulatory bodies like the FDA and EMA require rigorous statistical analysis for approving new drugs and treatments. Biostatistics ensures that studies meet these regulatory standards and that the results are reported transparently.

Example: Clinical trial protocols must include detailed statistical analysis plans (SAPs) that outline the pre-specified methods for analyzing data, which are critical for regulatory submissions.

7. Risk Assessment and Safety Monitoring
Biostatistics is used in ongoing monitoring of clinical trials to assess risk and ensure patient safety. This includes interim analyses, data monitoring, and adaptive trial designs.

Example: Interim analyses can help identify safety concerns early, allowing for timely modifications to the study or even stopping the trial if necessary.

8. Generalizing Findings
Biostatistical methods ensure that the results of a clinical study can be generalized to a broader population. This involves addressing issues related to external validity and ensuring that the study sample is representative of the target population.

Example: Techniques such as stratified sampling and weighting help ensure that study results are applicable to the broader population beyond the study sample.

Biostatistics is essential in clinical studies to ensure that the research is methodologically sound, the data is appropriately analyzed, and the conclusions drawn are valid and reliable. It provides the foundation for making evidence-based decisions that improve patient care and advance medical knowledge.