It is not much better in clinical studies. Reporting bias leads to over-estimating or under-estimating the effect of a drug intervention, and reduces the confidence with which evaluators can accept a test result or make judgments about the significance of such results. For any medicines or medical devices regulated by the FDA, posting at least basic results to ClinicalTrials.gov is mandatory within one year of study completion, but compliance is low. A 2013 estimate puts the failure to publish or post basic results at over 50%. No study results get reported at all in 78% of 171 unpublished but registered studies completed before 2009.
Reporting bias infects the evidence evaluation process for randomized controlled trials (RCTs), the basic experimental design for testing scientific hypotheses. That RCTs have limits is well-known. Each requires a large number of diverse participants to achieve statistical significance. Often the random assignment of participants or sufficient blinding of subjects and investigators is not feasible, and lots of hypotheses cannot be tested due to ethical concerns. For instance, sham or ineffective treatments given to seriously suffering patients harm those who might otherwise benefit. We also shouldn’t do an antisocial behavior RCT in a simulated prison environment and to get accurate data. When RCTs are ethical and well-designed, the critical opinions of experts is crucial, since a risk of bias is always present.
Peer-review assesses the value of RCTs, but the effectiveness of this process is compromised when relevant data are missing.Without effective peer-review we consumers of science and its applications have no coherent reason to believe what scientists tell us about the value of medical interventions or the danger of environmental hazards.
Not sharing, publishing, or making accessible negative results has numerous bad consequences. Judgments based on incomplete and unreliable evidence harms us. We probably accept many inaccurate scientific conclusions. Ioannidis (2005), for example, contends that reporting bias results in most published research findings being false.
Reporting bias harms participants in studies who are exposed to unnecessary risks. Society fails to benefit from the inclusion of relevant RCTs with negative results in peer-review evaluations. Researchers waste time and money testing hypotheses that have already been shown to be false or dubious. Retesting drug treatments already observed to be ineffective, or no more effective than a placebo squanders resources. Our scientific knowledge base lacks defeaters that would otherwise undercut flawed evidence and false beliefs about the value of a drug. RCTs and the peer-review process are designed to detect these but fail due to selective reporting.
RCT designs are based on prior research findings. When publishers, corporate sponsors, and scientists are unaware of previous negative results and prefer positive to negative results, many hypotheses with questionable results worthy of further testing are overlooked. Since all trials do not have an equal chance of being reported, datasets skew positive (erroneously) and this affects which hypotheses scientists choose to examine, accept, or reject.
Mostly positive results in the public record make the effect of a drug with small or false positive effects appear stronger than it actually is, which in turn misleads stakeholders (patients, physicians, researchers, regulators, sponsors) who must make decisions about resources and treatments on the basis of evidence which is neither the best nor available. Studies of studies (meta-analyses) reveal this phenomenon with popular, widely prescribed antiviral and antidepressant medications. Ben Goldacre tells a disturbing story about the CDC, pharmaceutical companies and antivirals.
A meta-analysis uses statistical methods to summarize the results of multiple independent studies. RCTs must be statistically powerful enough to reject the null hypothesis, i.e., the one researchers try to disprove before accepting an alternative hypothesis. Combining RCTs into a meta-analysis increases the power of a statistical test and resolves controversies arising from conflicting claims about drug effects. In separate meta-analyses from 2008 of antidepressant medications (ADMs) Kirsch,et al., and Turner, et al., find only marginal benefits over placebo treatments. When unpublished trial data get added back to the dataset, the great benefit previously reported in the literature becomes clinically insignificant. This is disturbing news: For all but the most severely depressed patients ADMs don’t work, and they may appear to work in the severely depressed because the placebo stops working, which magnifies the apparent affect of the ADM compared to placebo-controls.
Even when individual scientists behave well, the scientific establishment is guilty of misconduct when it fails to make all findings public. In order for science to be the self-correcting, truth-seeking process it clams to be, we need access to all the data.
Department of Philosophy