9th August 2013

The College of Psychiatric and Neurologic Pharmacists supports the AllTrials proposal to require universal clinical trial registration. The following are the organization’s primary concerns about the lack of universal clinical trial registration:

1.      Selective reporting of trials can result in misleading interpretation of the safety and efficacy of treatments.  This can compromise patient safety and lead to the use of ineffective interventions, which may in turn compromise patient health and result in wasting of limited healthcare resources.

2.      Selective reporting of trials can result in additional trials of treatments that have already been found to be ineffective or unsafe in prior trials, resulting in wasted resources and compromised research participant safety and outcomes.  Similarly, additional trials of safe and effective treatments may also subject participants to undue risk because participants may be randomized to less safe or less effective comparison interventions, placebo or otherwise.  Full knowledge of the results of prior trials is necessary to evaluate clinical equipoise of comparison treatments, which is necessary for randomized controlled trials to be ethical.

3.      Individuals participate in research with the expectation that their participation will lead to generalizable knowledge that will benefit others, if not themselves.  Researchers have a responsibility to study participants to use their data to contribute generalizable knowledge for the benefit of others