A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.
Interventions include but are not restricted to biomarkers, drugs, cells and other biological products, radiological procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc.1.
Clear and succinct patient outcomes.
Ultimately clinical trials are aimed to seperate the 'wheat from the chaff'. So many diseases/conditions come with a barrage of symptoms that are very similar to other diseases. Beyond physical symptoms and the psychology of both patient and practitioner, the aim of clinical trials to to quantify the disease, to put a number on it's presence and then to use this number to track changes around treatments, be they rest, diet, lifestyle or indeed drugs.
Class 1, week 1 of any science course will teach that observation of any experiment or system will introduce error. Error will produce skewed observations and thence incorrect conclusions. How do you overcome this error? Blind the data, observe from multiple angles, include multiple measures and ultimately listen to yours and the patient's gut feeling. The latter is a topic on it's own; placebo, etc.
The picture above perfectly illustrates what 'individual' observation means. If a practitioner follows only one observation and hence path, the patient may remain ill and potentially become worse. The counter to this, too much observation can muddy the waters even further. (? the current state of play in TBI/concussion research).The fine line; sensitive and specific measurements that diagnose and prognose the disease and minimise the need for human 'logic' to be used, but still require thorough observation from the treating physician.
The power of numbers imparts power to the physician and more importantly the patient as it demystifies their condition, quantities it and helps set up up goalposts to aim for.