Post-market surveillance

Ensuring that new medicines, medical devices and procedures are safe for patients should be part of everyday practice. In fact, it is so important that even just understanding the risks of therapeutics is a key discussion point between patient and clinician. Clinical trials are test therapies before they are approved for use in the market, so why are so many safety issues arise after a new therapy is already in use?

Regulators vary in their requirements for approving a new therapy but in all cases, efficacy is the main determinant for approval. However, a new therapy may work better than its predecessor most of the time, but it might also be harmful to some patients. Without using maths and in very broad terms:

• A severe harm for 1 patient in 10,000 is a trigger for re-evaluation of the therapy.
• If a therapy has this kind of risk, then over 50,000 patients would be required to establish the statistical link between the therapy and the harm.
• If such high numbers of patients were required for approval of new therapies, no new therapies would be approved both due to the unreasonable costs of the trial and the unrealistic expectation of recruiting that many patients.

To get this kind of required volume, an effective drug is first introduced to the market and then post-market surveillance is used to monitor its safety. In theory. In reality, post-market surveillance is difficult to fund and conduct and even clinicians may erroneously believe that if a therapy is approved then it is safe. Even when post-market surveillance is conducted, it is that as a single study that quickly becomes out of date.

The silver lining is that with Piano this gets much easier. Adding a post-market surveillance is as easy as copying and pasting a study, modifying the population and intervention and letting Piano automatically run over an entire dataset, automatically updating the result set as new patients are seen and conclusions change at a fraction of the cost and time it would normally be required to conduct a single study.