The Life of a Drug After Clinical Trials
During the development of a new drug, the primary focus is on assessing whether it’s safe (i.e., the benefit to the patient outweighs the impact of the side effects) and whether it works (Ref – Explanatory Trial/ Study). In order to answer these questions, it’s important to remove as many variables as possible, which means testing on patients who have as few as possible medical conditions, other than the one being investigated, and who are taking a minimal number of other drugs (i.e., concomitant medications).
However, the drug will be used on ‘real people’, which usually means we have a multitude of medical conditions (that seem to grow exponentially as we grow older) and we are taking a variety of drugs in order to combat these conditions and the side effects of the drugs. There are also the over the counter (OTC) drugs that we use when needed, such as painkillers, anti-histamines, hang-over cures etc.
The drug wasn’t tested in all these ‘real world’ scenarios, to do so would be impractical.
The Need for ‘Real World Evidence’
There is a significant knowledge gap regarding the benefit of these drugs once they have been approved.
We need to know whether these drugs work as well in the real world as they did in clinical trials and whether there are new side effects/ adverse reactions that were not seen previously. We also need to know whether the new drug is better/ more beneficial than drugs already on the market, whether it’s used properly by the prescribing doctors and the patients (i.e. as per the instructions provided in the drug label). Obviously, I’m over-simplifying things here, but you get the message.
So how do we get this information/ fill this knowledge gap?
We assess the use of these drugs in situations identical to, or close to, routine clinical practice. These assessments can either be interventional (e.g., we dictate which patients receive which drug in a research protocol, but the drug is still used according to it’s authorized purpose) or non-interventional (i.e., the patient is already receiving the drug and we collect information on how it’s being used, how well it’s working, and what side effects/ adverse reactions the patient experiences).