In public program evaluation, Randomized
Control Trials (RCT) are exulted, commonly referred to as the “Gold Standard.” However,
when applied to the field of Public Health, not all that is gold is good. Just
ask King Midas, a King found in Greek mythology who was gifted with golden
touch and then nearly starved himself and almost killed his daughter. The Gold
Standard can lead to ethical concerns and troubling outcomes.
As the name suggests, RCTs involve
randomly allocating participants into the treatment and control groups. The
treatment group undergoes the program that is being tested and their outcomes
are compared with the control group, who did not undergo the change. By
randomly assigning groups we achieve statistical independence, a person’s
decision to be treated verse not being treated has no effect on their outcome. RCTs
allow for researchers to eliminate selection bias to see the treatment effects,
the effects of the program that is being tested.
However, by making people’s decision
to be treated verse not being treated not affect the outcome, researchers can take
away individual’s ability to choose to be treated. A 2009 Bulletin of
the World Health Organization highlights some of these ethical concerns, which
they note are even more troubling when opting out of participating is
difficult. This is particularly an issue in Group Randomized Control Trials,
where documenting group consent is fraught with difficulty. The author’s outline
steps that can be taken by researchers to combat these ethical concerns, such
as not sacrificing individual consent for group consent.
Yet, focusing on individual consent
has the potential to invalidate results. Ideally, participants should reflect
the population the program is to target. However, if certain members of that targeted
population are unwilling to participate, the effects of that population is
unable to be fully analyzed. For instance, participants in a drug trial are
more likely to have undergone all other known treatments. Therefore the
treatment effects shown from a RCT may only be valid for the most extreme
cases. External validity, or the generalizability of results, is therefore
compromised.
Another concern with RCTs in health
policy is that just as there are concerns with the effects of a new treatments,
there also are concerns with denying treatments. To address this with drug
trials, just as there are protocols for stopping drug trials as a result of
negative outcomes, there are protocols for stopping trials as a result of
positive results. For instance, in the case of vaccines, when a vaccine shows
incredibly promising results, trails will be sped up or even cancelled in order
to give the public access more quickly.
Despite RCTs being called the “Gold
Standard” they are not without problems. In addition to difficulty conducting
RCTs, ethically concerns are particularly concerning in health related RCTs.
However, with this in mind, and proper protocols in place, RCTs do have their
role in health policy program evaluation.
