> We conducted the PARACHUTE trial to illustrate the perils of interpreting trials outside of context. When strong beliefs about the standard of care exist in the community, often only low risk patients are enrolled in a trial, which can unsalvageably bias the results, akin to jumping from an aircraft without a parachute. Assuming that the findings of such a trial are generalisable to the broader population may produce disastrous consequences.

>Before you jump to the conclusion that we’re suggesting we jettison RCTs from clinical research, let us clarify that that is not our intention. In an ideal world, new interventions would always be carefully evaluated through rigorous RCTs before widespread adoption. But when pre-existing convictions about an untested intervention affect the population enrolled, even a well conducted RCT can provide misleading results. Without careful attention to context, extrapolating findings from such an RCT to the patient in front of us may be, well, a leap too far.