Outcomes of patients who participate in randomised controlled trials compared to similar patients receiving similar interventions who do not participate

The culture of designing hepato-biliary randomised trials

“…Outcomes of patients who participate in randomised trials are just as good as those of similar patients receiving the same treatments outside trials [21]. Interventions tested in trials may harm.…”

Regulation of Therapeutic Research is Compromising the Interests of Patients1

“…(additional investigations, for example), the best evidence sugHowever, as illustrated by the examples given earlier in this paper, gests that participation poses no special risk compared with receivresearch ethics committees sometimes exercise their powers in ing treatment outside a trial: on average, routine care is just as ways that are manifestly not in the interests of patients receiving dangerous/safe as care within trials. [39] Indeed, some people have inadequately evaluated treatments. Regulations and the judgments maintained that the closer attention devoted to the treatment of of committees need to be tailored to reflect the likely risks of participants in controlled trials may confer benefits.…”

Placebo-controlled trials in psychiatry on trial

“…One of the concerns about RCTs is that by randomisation, patients are exposed to risks they would not face if they had not participated in such trials. Systematic reviews of the evidence indicate that participation in RCTs is not associated with greater risks than receiving the same treatment outside RCTs (9) and that participants given the active intervention as well as controls had better outcomes than those who declined participation, even after adjusting for prognostic confounders (10). This suggests a non-specific "Berksonian" effect of better care accruing from trial participation.…”