A key decision in the planning of a clinical trial is that of the sample size. As we’ve discussed previously, the number of participants in a trial is key to whether it will provide useful results – specifically whether the trial will have enough statistical power. Simultaneously, the cost and complexity of a trial can…
One common use for bioassays is to test manufactured biologic products before they are released to the wider consumer market. While all bioassays used for this purpose will have undergone stringent testing and validation, it is vital that their ongoing performance is closely monitored to ensure that any changes in the assay system do not…
The earliest stages of the development of any vaccine involve laying out the roadmap for its design and testing. A vast network of interlinked paths from a new idea to a needle in a patient’s arm stretch ahead into the future, each with unique regulatory and ethical implications. Should the vaccine target a certain strain…
If you’ve ever taken a rapid test for COVID-19, then you’ve used an in vitro diagnostic device (IVD). At the start of the pandemic, the only reliable method for determining whether a patient was currently infected with COVID was a slow PCR test which required processing in a lab to return a result. By contrast,…
The idiom “to pull oneself up by their bootstraps” originated in the late 19th century. At first, it implied impossibility, but has since shifted to mean advances achieved through grit, determination, and hard work, often in business or in one’s career. Thankfully, the statistical method – bootstrapping – named for the idiom rarely requires such…
The Organisation for Economic Co-operation and Development (OECD) is an inter-governmental organisation which aims to facilitate global trade and economic development. A key area is the development of global standards. The OECD’s Good Laboratory Practice (GLP) scheme is an example of such standards: It provides guidance on all aspects related to non-clinical health and environmental…
Statistics is divided between two camps: the frequentists and the Bayesians. The latter of these has begun to attract more popular attention in recent years with the rise of AI and other similar technologies. This has extended to the life sciences, in which there are several fields where Bayesian approaches are taking centre stage. So,…
This blog introduces the concept of multiplicity, why it is important and offers some techniques for dealing with the issue. When planning a clinical study, lots of thought is put into what to measure – i.e., which data needs to be collected, how it should be analysed. This leads to the definition of so-called endpoints….