To perform any experiment, it is vital to ensure that enough data is collected. Too little data can not only mean imprecise results, but also makes distinguishing between reality and statistical fluke difficult. This concept of statistical power – and, inherent within, sample size – is a key component of trial design: consideration must be…
One key challenge when developing vaccines for human use is that it is often infeasible or unethical to assess the efficacy of the candidate vaccine directly in humans. As we’ve discussed previously, diseases which are severe, rare, or both are difficult to accommodate in human testing. This poses a quandary: these diseases are often the…
When we discuss the performance of a vaccine, properties such as its immunogenicity, adverse event frequency, and any correlates of protection are usually among the first to be mentioned. A property which is considered less often is when a patient can expect to be protected after they have received the vaccine. This is known as…
When scientific a study is evaluated, the sample size is often among the first issues brought up. Whether it’s the number of participants in a study, the number of times an experiment is run, or even the number of people asked to complete an electoral poll, it is well-known that – in general – a…
A concept we’ve discussed several times over the years is that of homogeneity of variance. We highlight it so regularly as it’s among the most critical properties that relative potency data must have before valid statistical inference can take place, and often requires careful consideration to realise. We’ve previously covered one common way to ensure…
In our blog introducing bioequivalence, we described how studies establishing bioequivalence can be a way to avoid expensive clinical trials without compromising on the safety or efficacy of a drug product. In particular, this applies for generic versions of already approved drugs, or for different dosage routes for those drugs. In these cases, bioequivalence studies…
One of the greatest challenges in the development of new drugs and therapeutics is that it’s just plain expensive. The average spend on a drug which passes clinical trial is on the order of billions of dollars – and don’t forget that more than 90% of drug candidates don’t make it to market – meaning…
There are essentially two types of allocation we can make when forming clinical trial groups. The first is a random allocation, which, as you would expect, is unpredictable: the study group to which the subject is assigned is unknown before the process takes place. The second is formally known as deterministic, but we’re going to…