Clinical trial data: Potential ethics violations

Abstract

Biomedical ethics is a vital component of clinical research whose application must be extended to all stages of a clinical trial including data processing and publication. The concept of biomedical ethics rests on principles of autonomy, beneficence, non-maleficence, and justice.¹ These ethical principles are framed to protect the rights of the participants during the clinical trial. Similarly, it is also vital to protect the clinical trial data from potential ethics violations. Clinical trial data violations include P hacking and the failure to register and/or publish clinical trials.

P-hacking: As a desperate measure to obtain statistically significant results, the researchers may resort to P-hacking. P-hacking represents a form of data manipulation, wherein the non-favorable or non-significant results are excluded to increase the chance of obtaining a statistically significant result.^2,3

Clinical trial registration: Researchers often fail to register their clinical trials, especially when the results are not favorable or have no statistical significance. Thus, data extracted from clinical trial registries are significantly biased due to the under-representation of insignificant or negative data.^4,5

Publication: Like clinical trial registration, researchers have been inclined to publish clinical trials with statistically significant results than those with unfavorable or insignificant results. This, in turn, results in severe bias in the systematic reviews and meta-analyses based on clinical trial publications.²

Thus, although strict ethical principles may have been followed during the clinical trial, the resulting data may be either manipulated to generate favorable results or remain unpublished and/or not registered due to negative results. Systematic reviews and meta-analyses based on these biased and P-hacked data are used to formulate treatment protocol, thus posing significant health risks to the patients. Thus, we propose that the institutional ethics committee (IEC), in addition to supervision during the clinical trial must also confirm the registration of the trial with the appropriate registry and monitor the processing of the clinical trial data including data analysis and publication. Further, all journals must mandate the authors to provide the register number of their clinical trials during submission. The journals must validate the registration number with the respective registries to confirm the authenticity of the clinical trial. Thus, to conclude, in addition to ensuring the rights, safety, and well-being of the research participants during the trial, the IEC would also aid in preventing any potential ethics violation during clinical trial registration, data processing, and publication of the clinical trial.

Footnotes

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

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