By Anatomise Biostats

Strategic Biometrics: The Case for Outsourcing in Medical Device Clinical Investigations

Biostatistics, Clinical Trials, Med-Tech & Medical Device, Pharma & Drug Development, Uncategorized
The integrity of a clinical investigation relies entirely on the precision of its data. As trial designs grow more complex, the scope of biometrics expands accordingly. Biometrics spans biostatistics, statistical programming, and data management. Medtech sponsors often build internal data teams, sometimes assuming that general data science or AI expertise translates to sound regulatory biostatistics. Clinical investigations, however, require a…
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By Anatomise Biostats

Fake vs Synthetic Data: What’s the difference?

Biostatistics, Clinical Trials, Uncategorized
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 Anatomise Biostats

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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By Henry Budds

How much does developing a novel therapeutic cost? – Factors Affecting Drug Development Costs across the Pharma Industry: A mini-Report

Clinical Trials, Pharma & Drug Development, Uncategorized
Introduction Data evaluating the costs associated with developing novel therapeutics within the pharmaceutical industry can be used to identify trends over time and can inform more accurate budgeting for future research projects. However, the cost to develop a drug therapeutic is difficult to accurately evaluate, resulting in varying estimates ranging from hundreds of millions to billions of US dollars between…
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By Sabine Dreibe
Bayesian approach for sample size estimation and re-adjustment in clinical trials

Bayesian approach for sample size estimation and re-adjustment in clinical trials

Uncategorized
            Accurate sample size calculation plays an important role in clinical research. Sample size in this context simply refers to the number of human patients, wheather healthy or diseased, taking part in the study. Clinical studies conducted using an insufficient sample size can lack the statistical power to adequately evaluate the treatment of interest, whereas a superfluous sample size can…
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