Randomized Controlled Trials in Environmental Health Research: Unethical or Underutilized? PLoS Med, Jan 2015.
Authors: Ryan W. Allen , Prabjit K. Barn, Bruce P. Lanphear
Randomized controlled trials are standard practice in clinical and pharmaceutical research but have not been embraced by environmental health researchers. Greater use of the RCT design would complement the tremendous contributions made by other methods—including both observational epidemiology and toxicology—to our understanding of environmental risks and the development of environmental health policy.
Researchers, academic institutions, and funding agencies have a role to play in expanding the use of RCTs in environmental health research. Researchers should think creatively about potential interventions and consider the RCT as a possible study design to test their specific research question. Funding agencies should allocate money specifically for randomized studies of environmental interventions.
In addition to its scientific advantages, this would provide the additional benefit of encouraging research that aims not only to identify problems but also to identify possible solutions. Ethical issues must be considered carefully, and while institutional ethics approval is necessary, it is not sufficient to ensure that the research is conducted ethically. The RCT design has important limitations and is not applicable to all research questions, so observational studies will, and should, remain the workhorse in environmental health research.
Nevertheless, RCTs can help advance the field of environmental health by creating new knowledge of exposure–health relationships, providing more definitive evidence of causality, identifying efficacious interventions to reduce or eliminate exposure and health risks, and countering the perception that environmental risks are evaluated with inadequate rigor.