CRF Design for Clinical Studies: The Distinct Roles of Data Managers vs Biostatisticians
In 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 requires input from two key roles: the data manager and the biostatistician. While their contributions may overlap in some areas, these roles…
Why Biostatistics Qualifications Matter in Med-Tech Industry Clinical Trials.
In the medtech industry, a growing misconception equates proficiency in statistical software with competence in clinical trial design. As data pipelines become more automated, statistical analysis is increasingly delegated to professionals from adjacent fields, such as biomedical engineers, bioinformaticians, or data scientists. While these disciplines possess strong computational skills, they often lack the in-depth biostatistical training required to safeguard a clinical trial. The result is a fundamental misalignment between…
Strategic Biometrics: The Case for Outsourcing in Medical Device Clinical Investigations
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 highly specific regulatory and statistical framework. Building a dedicated…
Stata: Statistical Software for Regulatory Compliance in Clinical Trials
Stata has been widely used for decades in various research domains such as economics, biosciences, health and social sciences, including clinical trials. It is widely referenced in studies published in reputable scientific journals. While SAS has a longer history of being explicitly referenced by regulatory agencies such as the FDA, Stata can still meet regulatory compliance requirements in clinical trials. StataCorp actively engages with researchers, regulatory agencies, and industry…
Sex Differences in Clinical Trial Recruiting
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 cases safety and efficacy outcomes are pooled, rather than…
Estimating the Costs Associated with Novel Pharmaceutical development: Methods and Limitations.
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 trial units and random samples from private databases3,9,10,14,15,16. Other…
How much does developing a novel therapeutic cost? – Factors Affecting Drug Development Costs across the Pharma Industry: A mini-Report
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 studies. The high cost of drug development is not…
The Role of Precision Medicine in Drug Development and Clinical Trials
With the help of precision medicine, or personalised medicine, modern medicine has moved away from a ‘one size fits all’ approach to treating disease and towards therapeutic approaches that are tailored to individuals and subgroups. These treatments are designed to be more efficacious due to targeting population subgroups based on their genetic or molecular nuances, rather than operating on the assumption that all bodies function and respond the same…
Clinical Trial Phases in Drug Development
The development of new drugs starts far before they are even seen in clinical trials. The discovery of multiple candidate drugs occur early on in the development process, often as a result of new information about how a disease functions, large-scale screening of small molecules, or the release of a new technology. After a promising drug has been found, pre-clinical studies can be performed. A pre-clinical study for a…