The ethics of reporting all the results of clinical trials

Abstract

There is room for further work on how protocols requiring that data be publicized might be enforced; should it be statutory, or non-statutory? Who should decide what should be made public? There is also room for work on what it is necessary to share, and on whether and how IP law should be reformed.

Lack of clinical trial data transparency and current solutions

“…This leads the public, including health care practitioners, to be misinformed and unintentionally develop a skewed opinion of the treatment [2]. As a result, treatments become overvalued and their harmful effects become underestimated, leading patients to potentially be exposed to toxicities and adverse events in the absence of any clinical benefits [3].…”

“…As a result, treatments become overvalued and their harmful effects become underestimated, leading patients to potentially be exposed to toxicities and adverse events in the absence of any clinical benefits [3]. Moreover, without an in-depth understanding of the treatment in question, it is impossible for physicians to make a proper comparison between various treatments [2]. Consequently, a physician may select a promising drug based on the presented data, as opposed to another drug that would have been a safer choice [2].…”

“…Moreover, without an in-depth understanding of the treatment in question, it is impossible for physicians to make a proper comparison between various treatments [2]. Consequently, a physician may select a promising drug based on the presented data, as opposed to another drug that would have been a safer choice [2]. A well-documented example that highlights the consequences of selective reporting is rofecoxib (Vioxx), a COX-2 inhibitor [3].…”

“…Furthermore, without a clear representation of clinical trial results, selective reporting could lead other investigators to conduct similar trials exposing patients to adverse effects that may have been prevented with clear communication [2]. Not only does this put more patients at harm's risk, it wastes time and money that could have been spent on alternative treatments [2].…”

“…Therefore, it is imperative that these results are accessible to physicians so they may determine the best treatment options for their patients. However, a current issue in clinical research is the absence of data obtained through these trials, thus limiting the basis on which physicians make their decisions [2]. This has caused the safety of patients to be at risk and will continue doing so unless the proper steps and regulations are implemented [2].…”