By Anatomise Biostats

Strategic Sample Size Solutions for MedTech Startups: Navigating Software vs. Expert Support

Uncategorized
A comprehensive guide for medtech sponsors and clinical teams on optimising sample size calculations for clinical trial success The Critical Crossroads Every MedTech Sponsor Faces As a sponsor or member of a clinical team in the MedTech industry, you're tasked with making critical decisions that impact the success of clinical trials. One of the most pivotal choices you'll face is…
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By Sarah Baker

Treatment-Adaptive vs Response-Adaptive Randomisation: A Practical Guide for Medtech Trials

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Medical device trials increasingly incorporate adaptive randomisation to improve efficiency and patient outcomes. Two main approaches have emerged: treatment-adaptive randomisation (TAR), which modifies allocation probabilities at pre-planned interim analyses, and response-adaptive randomisation (RAR), which updates allocations continuously based on patient outcomes. The choice between these methods depends on trial characteristics including endpoint timing, data infrastructure, regulatory requirements, and scientific objectives.…
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By Anatomise Biostats
Biostatistics, Clinical Trials, Med-Tech & Medical Device, Pharma & Drug Development, Uncategorized
CRF Design for Clinical Studies: The Distinct Roles of Data Managers vs Biostatisticians In medtech clinical trials, the Case Report Form (CRF) is more than a tool for collecting data—it’s the backbone of the study. From capturing critical safety outcomes to evaluating device performance, a well-designed CRF ensures that the study’s goals are met efficiently and reliably. Achieving this balance…
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By Sarah Baker

Expert Opinion: Why Biostatistics Qualifications Matter in Med-Tech Industry Clinical Trials.

Biostatistics, Clinical Trials, Med-Tech & Medical Device, Pharma & Drug Development, Uncategorized
Consider the consequences if a medical doctor, without a formal medical education or licensing, were to diagnose and treat patients. Such a doctor might misunderstand symptoms, choose the wrong treatments, or even harm patients due to lack of understanding and experience. Similarly, an unqualified biostatistician might incorrectly analyse data, misinterpret statistical significance, or fail to recognise biases and patterns essential…
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By Anatomise Biostats

Biometrics & Clinical Trials Success:

Biostatistics, Clinical Trials, Med-Tech & Medical Device, Pharma & Drug Development, Uncategorized
Why Outsourcing a Biostatistics Team is Pivotal to the Success of your Clinical Trial Clinical trials are among the most critical phases in bringing a medical device or pharmaceutical product to market, and ensuring the accuracy and integrity of the data generated is essential for success. While some companies may feel confident relying on their internal teams, especially if they…
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By Anatomise Biostats

Fake vs Synthetic Data: What’s the difference?

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The ethical and accurate handling of data is paramount in the domain of clinical research. As the demand for data-driven clinical insights continues to grow, researchers face challenges in balancing the need for accuracy with the availability of data and the imperative to protect sensitive information. In situations where quality real patient data is not available, synthetic data can be…
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By Sarah Baker

The role of Biostatisticians, Bioinformaticians & other Data Experts in Clinical Research

Biostatistics, Clinical Trials, Uncategorized
As a medical researcher or a small enterprise in the life sciences industry, you are likely to encounter many experts using statistical and computational techniques to study biological, clinical and other health data. These experts can come from a variety of fields such as biostatistics, bioinformatics, biometrics, clinical data science and epidemiology. Although these fields do overlap in certain ways…
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By Sophia Puliasis

Sex Differences in Clinical Trial Recruiting

Biostatistics, Clinical Trials, Med-Tech & Medical Device, Pharma & Drug Development, Uncategorized
The following article investigates several systematic reviews into sex and gender representation in individual clinical trial patient populations. In these studies sex ratios are assessed and evaluated by various factors such as clinical trial phase, disease type under investigation and disease burden in the population. Sex differences in the reporting of safety and efficacy outcomes are also investigated. In many…
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By Henry Budds

Estimating the Costs Associated with Novel Pharmaceutical development: Methods and Limitations.

Clinical Trials, Pharma & Drug Development, Uncategorized
Data sources for cost analysis of drug development R&D and clinical trials Cost estimates for pre-clinical and clinical development across the pharmaceutical industry differ based on several factors. One of these is the source of data used by each costing study to inform these estimates. Several studies use private data, which can include confidential surveys filled out by pharmaceutical firms/clinical…
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