Last week we asked the question ‘Does RWE influence clinical practice?’, but a recent study published by JAMA Internal Medicine has taken a different approach to the issue of RWE, clinical trials and their translation to clinical practice. Clinical trials are the foundation of evidence-based medicine – but what if the patients that take part in trials are not representative of the rest of the population?
A group of researchers looked at the characteristics of patients who contributed data to the American College of Cardiology (ACC) ambulatory cardiology practice registry. They compared the characteristics of the registry group with those who enrolled in the IMPROVE-IT trial. The IMPROVE-IT trial demonstrated that adding ezetimibe to simvastatin in patients with acute coronary syndrome reduced cardiac events by 2% over 7 years.
When trial participants were compared with patients on the registry, the registry patients were “significantly older, more likely female, had markedly higher rates of peripheral arterial disease, heart failure, and hypertension, and had lower rates of secondary prevention medication use.”
These findings put the results of the IMPROVE-IT trial in doubt.
Did this happen by chance?
The researchers involved in this comparative study wanted to find out if they were focussing on something that could have happened by chance. For example, it may have been the case that the groups differed so much because people who agree to take part in trials are more likely to be older.
Researchers used data from the registry to determine the proportion of registry patients who would have qualified for the IMPROVE-IT trial.
Only one-third of registry patients with acute coronary syndrome would have been eligible to take part in the trial. The trial called for patients that were older, sicker, and received less optimal secondary prevention therapies.
Does it matter?
The findings presented could have a big impact on the trial results. The critical word there being ‘could’ – we simply do not know for sure. The researchers concluded that it is “unclear if the effect seen with simvastatin/ezetimibe use in the trial translates to current patients with acute coronary syndrome”.
The fact we don’t know means the trial was futile. Trials aren’t cheap either – and this is a textbook example of research waste.
What can we do to avoid this situation in the future?
We need to ensure we’re recruiting participants into trials that are representative of the real-world populations that their results will impact. At Ignite Data we have the capability to do this. Use data from the real-world to perform robust feasibility studies, recruit participants, and ensure the data you collect is of high quality.
We’re unsure how widespread this problem is, but it’s clear that we can help. Get in touch to find out how Ignite Data can strengthen your clinical trials.