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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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 Sarah Baker

Medical Device Categorisation, Classification and Regulation in the United Kingdom

Clinical Trials, Med-Tech & Medical Device
Contributor: Sana Shaikh In this article Overview of medical device categorisations and classifications for regulatory purposes in the United Kingdom Summary of medical devices categorisations based on type, usage and risk potential during use as specified in the MDR and IVDR. The class of medical device and its purpose determines the criteria required to meet regulatory approval. All medical devices…
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By James Des-Rosiers

Regulation of Connected Medical Devices and IOmT

Clinical Trials, Med-Tech & Medical Device
Collection and transmission of personal biologic and health information via IOmT connected medical devices requires regulatory oversight and has cybersecurity implications. Connected medical devices (CMDs) can produce and transmitting patient data, allowing their condition to be monitored by healthcare professionals. They are often used in decentralised clinical trials (DCTs) outside of the clinical trial site, allowing for participants who wouldn’t…
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By Sophia Puliasis

The Role of Precision Medicine in Drug Development and Clinical Trials

Clinical Trials, Pharma & Drug Development
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…
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By Rosetta Aires

Mini Report: Why do clinical trials fail? 

Clinical Trials
Overview Clinical studies are time-consuming, expensive, and frequently pose challenges for participants and sponsors alike. This article explores some of the numerous factors contributing the failure of a clinical study and offers suggestions on how to increase the likelihood of designing and carrying out effective clinical trials.Pharmaceutical and medical device clinical trials present several chances for failure. Failures can occur…
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By Henry Budds

Emerging use-cases for AI in clinical trials

Clinical Trials
Overview Clinical trials are becoming more expensive where, according to a Deloitte’s report1, the average cost to get a drug to market in the USA was $1.188 billion in 2010, and $1.981 billion in 2019. This increase in cost reflects the difficulties that are associated with current linear clinical trial designs. Clinical trials can take a long time due to…
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By Sabine Dreibe

4 common study designs for clinical trials

Clinical Trials
Clinical trial design is an important aspect of interventional trials that serves to optimise, ergonomise and economise the clinical trial conduct. The goals of a clinical trial, whether medtech or pharma, can encompass assessment of safety, dosage optimisation, evaluation of efficacy or accuracy and comparison to existing treatments or diagnostics. This of course varies with the phase of the trial.…
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