Transparency of Research Methods: Proud to be a Naked Emperor

Publication Bias, Politics, and Clouded Publication Processes 

Publication bias (ie, studies with positive results are more likely to be published or given priority in publication) may result in misleading conclusions.2, 3, 4 If only selected articles are published, such as those reporting positive results, then essential articles are left out of the literature.4, 5 In addition, if articles about one treatment are published, but articles about potentially better, safer, or more cost-effective treatment are not, the missing information could have a considerable impact on health policy decisions and the application of care to patients. In a time when we call for evidence-based practice methods, we are at risk for causing harm if all information is not provided in order for stakeholders to make informed decisions.2

Although considered inappropriate, there are reasons not to disclose or publish studies. The author of a study with negative or inconclusive findings may not complete the project, for fear it would not be accepted by a journal or that the author would not receive continued funding from a funding source.2 As well, a researcher may terminate a study because the findings do not align with or prove his own point of view.

A political group, funding body, or those with commercial interests, may put pressure on a researcher to abandon a study if the results do not support the organization's financial or political gain. If this occurs, the results of such a study would be unknown and inaccessible.6 Alternatively, a researcher may be pressured into modifying study results so that the results appear positive, when in reality, they are not (eg, through data alteration, changing the research hypothesis, including only subsets of data, etc).

A decision not to publish may also occur after a manuscript has been submitted to a journal. A study with negative (ie, acceptance of the null hypothesis) or inconclusive findings may not receive high priority from some editors or may receive reviews that are based on the outcome instead of the merit and scientific integrity of the study.4, 7 The International Committee of Medical Journal Editors' guidelines suggest that there is an obligation for editors to seriously consider the publication of negative studies.8

Clinical Trial Registries 

Efforts should be made to reduce, prevent, or avoid reasons for clouding publication processes, and one of these actions is the promotion and use of clinical trial registries.2, 9 The concept of clinical trial registries is not new; they were described in the 1970s during the creation of registers intended to assist patients in entering a trial, to help physicians know what was available, and to provide scientists a source of human subjects for their trials.2 To promote these same efforts 30 years later, the International Committee of Medical Journal Editors' guidelines state that clinical trials should be included in a clinical trial registry to be considered for publication in a biomedical journal (for trials recruiting patients on or after July 1, 2005).8, 10 This stance promotes the development of a comprehensive, publicly accessible clinical trials database.

The benefits of having clinical trials registered include the following: trials will be accounted for; prevention of duplication of research efforts; increased access and human participation in trials; treatment decisions based potentially on all available evidence; ethical obligation to participants, patients, researchers, and funding bodies will be fulfilled; facilitation of collaboration of research efforts; and transparency of the research process.2, 6 Some may argue that chiropractic or alternative health care research does not belong in clinical trial registries; however, the arguments for inclusion of these studies, as stated above, are compelling. Web sites relating to clinical trial registries are listed in Table 1.

Table 1. A list of Web sites containing clinical trial registry information

	http://www.controlled-trials.com/
	http://www.clinicaltrials.gov/
	http://www.nhmrc.gov.au/research/general/clincreg.htm
	http://www.clinicaltrials.com/
	http://www.trialscentral.org/
	http://www.centerwatch.com/
	http://www.update-software.com/National/

Fear of Being Naked 

Some may be fearful of research transparency and the use of clinical trial registries. Certainly, there are many arguments surrounding these issues, but one subversive motivator for some stakeholders is secrecy. In disclosing information about research, there may be a fear of “big brother” knowing what is occurring with a research agenda or a fear of funding termination. Being included in a clinical trial registry may create fear of other scientists “stealing” ideas and research plans or that another company may steal trade secrets. However, we must ask if the benefits of secrecy outweigh the risks to public health.

If one agrees that decisions in patient care and health care policy should be made using all available quality evidence, then transparency seems to be a logical solution. Clinicians, policy makers, scientists, and patients may make better informed decisions knowing if a procedure or technique has no advantage over another, if it is not as good as another, or if it is harmful.2, 6

Whittington et al11 showed the potentially devastating results of not publishing research findings. Their investigation compared published and unpublished data of pediatric antidepressant selective serotonin reuptake inhibitors clinical trial data. When looking at the published data alone, the benefits of taking these medications outweighed the risks. However, when the unpublished data were included in weighing the evidence, the findings showed the risks outweighed the benefits. This study showed that not having all information might lead to errors in patient management for this group of patients who were at risk for suicide. This is one example that supports why some consider it unethical not to publish findings from scientific investigations.

Conclusion 

The publication world is becoming more complex, and there are no simple solutions. Being aware of potential pitfalls, setting clear policy about publication guidelines, encouraging clinical trials to be recognized through registration/publication, and promoting honest reporting in the health care literature may help to improve transparency.2, 4, 6 In spite of the risks that are inherent to transparency, we need to consider what might happen if we do not take this risk. Ultimately, we should consider being honored to be a naked emperor by encouraging transparency of publication. We owe this action to those who access health care information and to those it ultimately affects, our patients.