Abnormal Psychology. William J. Ray

      Why do so many clinical studies go unpublished?

      © iStockphoto.com/triloks

      Imagine that you have just set up a new program for treating an eating disorder. How do you know the new treatment you developed works? The gold standard is to perform a randomized control trial involving the treatment. In this case, you would randomly select individuals with a particular eating disorder who would either receive your treatment or an alternative, usually a placebo. Once the study is complete and your treatment works, what do you do next?

      If you are like most scientists, you write up the results and publish them. However, if your treatment did not show a significant difference in comparison to the alternative, what do you do then? The ideal response is to publish the results so that the world knows not only what works, but also what does not work. However, publication of negative results does not always happen. Sometimes, scientists move on to more productive projects. This failure to publish negative results has come to be called the file drawer problem. This phenomenon is a significant complication if you do a literature search. Typically, your literature search shows you the treatment studies in which the treatment made changes in the disorder. However, what you do not see are those studies that did not find a significant change, as they remain unpublished in the researcher’s file drawer or computer.

      Why would so many studies go unpublished? Researchers, based on their own treatment preferences, might not like the results of a study that didn’t verify certain treatment effectiveness. Large drug companies encourage the publication of studies whose results supported their own interests. Journals choose to publish research articles that found positive results. All of these factors contributed to the so-called file drawer problem.

      To help deal with this problem, in 2007 the U.S. government passed an amendment to the Food and Drug Administration Act. This requires clinical trials of drugs, medical devices, or biologics to be registered at the website ClinicalTrials.gov. Further, a basic summary of the results is required to be submitted through the website within 1 year following the completion of the data collection. This was considered to be an ethical obligation to human participants to present results in an understandable fashion.

      In order to determine the rate of compliance with the law, Monique Anderson and her colleagues (2015) examined 13,327 studies that ended during the period from 2008 to 2012. Of these, over 77% were drug trials. Of all the trials, only 13.4% reported summary results within 1 year of completing the research. When using a 5-year time frame, 38.9% reported summary results.

      A British physician, Ben Goldarce, is part of an international campaign called ALLTrials, which seeks to require researchers worldwide to publish their results. He noted that an antidepressant he had prescribed for his patients showed positive results in the published literature. Whereas the published literature showed this antidepressant to be as effective as any other antidepressant drug, unpublished data involving 3 times as many people as the published data did not find the same results. A similar situation happened for another type of antidepressant drug, referred to as SSRIs (selective serotonin reuptake inhibitors). Prozac is one example of this class of drugs. Although these were introduced in the 1980s, it was not until 2006 that data submitted to the FDA showed a relationship between the drug and suicidal ideation in adolescents. Further, only 51% of the studies submitted to the FDA showed that use of SSRIs led to a positive result, whereas 94% of published studies showed positive results.

      Thought Question: What role should the U.S. federal government play in ensuring treatment data from all clinical trials are available to the public?

      (Based on “Failure to Publish the Results of All Clinical Trials Is Skewing Medical Science,” The Economist, July 25, 2015)

      Concept Check

      Ethics and the Scientific Experiment

      Ethics is the study of proper action. Ethics examines relationships between human beings and provides principles regarding how we should treat each other. The ultimate decision in ethical questions resides in judgments of value. Ethical considerations of psychological experimentation have at their heart the idea that people participating in research should not be harmed (see Ray, 2012). Specifically, at the end of an experiment, participants should not be affected in a way that would result in a lower level of human functioning. This includes emotional distress.

      ethics: the study of proper action

      In most cases, the scientist has a question that he or she wants to ask and that the participant is willing to help answer. In some cases, the participants learn something about themselves from the experience and they are glad to have participated. In brain imaging studies, for example, participants often report that they enjoy seeing their brain activity (e.g., functional magnetic resonance imaging [fMRI], electroencephalography [EEG]) displayed. Thus, they are willing to participate in research in exchange for these types of experiences.

      If these experiences were always pleasant and any changes in the participant always positive, participants would participate gladly in experiments, and scientists would face few ethical questions. However, at times the scientist may want to answer a question that requires that the participant experience psychological or physiological discomfort. In terms of psychopathology, we need to be especially certain that the individual with a particular disorder understands what is being asked of her and can freely respond. These situations raise a number of questions:

      Since the 1950s, the American Psychological Association (APA) has published a set of guidelines. This is available online at www.apa.org/ethics/. In 1974, the National Research Act was signed into law in the United States. This law sought to protect human research participants. In response to the law, the Department of Health, Education, and Welfare held a conference in 1976 and produced a report. This is referred to as the Belmont Report (http://ohsr.od.nih.gov/guidelines/belmont.html). The Belmont Report identifies three basic ethical principles—respect for persons, beneficence, and justice.