We’ve mentioned before about the COMET initiative, that was born from lots of work in rheumatology, and seeks to standardise a core set of outcomes collected in clinical trials so that the trial
- Measures things of importance to patients, clinicians and researchers and
- Provides a degree of homogeneity that makes systematic reviews more powerful
Well, those clever rheumatologists have done it again, conceptualising the whole of it into two major areas, and breaking them up into manageable parts.
The paper, open access and relatively readable, is here but the key importance comes from
The bubbling down of it is how does the condition affect the life of the patient; mortality, morbidity in its broadest sense, and the resources required in each arm of the trial. And then beyond that, how does the disease present itself to the world – in surrogates, biomarkers, organ changes and measurable abnormalities.
By setting a cornerstone on each of these elements, we can then make sure any trial helps patients understand the impact of the treatment upon them, clinicians appreciate what might be improved and the costs to be expended, and researchers look to see how the presumed pathology works in the reality of real people free living in the world.
This won’t be retroactive, but like the CONSORT statement and the requirement for trial registration, it’s a step towards improving all trials in humans. Now if only someone would start a campaign to get AllTrials reported too …