Wasted research: Why are there so many unpublished clinical trials?

Waste is never good, but we don’t live in a perfect world. People make mistakes, items are not always utilized to their utmost extent, food spoils before it is eaten and things get thrown away. Just like in the rest of the world, a certain amount of waste is considered acceptable in the sciences. It’s not uncommon that experimental reagents can expire before they are fully utilized. Experiments can go awry, and will need to be repeated. It’s life. When waste reaches a high level in a lab or in society, however, people begin to wonder. What is going on? Is this a sign of negligence or perhaps something worse?  High levels of waste are always unacceptable, especially when it comes to clinical trials.

In a recent British Medical Journal article, “Publication of NIH funded trials registered in ClinicalTrials.gov: Cross sectional analysis,” Dr. Joseph Ross, an Assistant Professor of Medicine at Yale, along with several colleagues, found that only 46 percent of 695 clinical trials that were registered after September 30, 2005, and completed by December 31, 2008, were published within thirty months following the completion of the clinical trial. Within 51 months, one-third of the trials still remained unpublished. A similar trend was also observed with clinical trials funded by pharmaceutical companies and non-profit organizations.

It is not entirely clear why much of this research has yet to be published after four years. Were there mistakes in some of these clinical trials? Was the science flawed? Or perhaps the data wasn’t good enough to warrant publication. There is a historical precedent (a wrong precedent, I might add) that scientists and journals should only publish data that is largely positive, while ignoring data that is considered negative. Positive data implies, for example, that a tested drug compound acted better than a placebo in a clinical trial. Negative data implies that the tested drug did not act better than a placebo. In reality, data is data. Whether a drug compound showed an effect or not, the research is important. While journals and researchers are beginning to see the importance of negative data, the influence of previously conceived notions is still detrimentally affecting research. According to Ross, if clinical trial managers viewed the publication process with as much importance as the actual trial itself, no matter the data outcome, the level of unpublished research would likely diminish greatly.

To be honest, the publication process itself can take some time. Perfecting a manuscript for publication can take several weeks to several months before it is ready to be submitted to a journal. A journal itself can take several weeks before it decides to accept a manuscript for publication and the article often will not be published for several more months after that. This time frame may be extended if the manuscript is not accepted for publication, requiring the scientists to make minor tweaks to an article before it is submitted to a different journal.

Any which way you swing it, from delays in publication to outdated concepts of “good data,” delaying the release of clinical trials diminishes the impact of this research and causes its validity to be questioned. Not releasing this data can waste time and money, while also delaying further scientific innovation. More importantly, it is a direct insult to the human volunteers that may have put their health on the line for this research to succeed. Human clinical trial participants should never be wasted.

By understanding the underlying cause for the delay in clinical research, improved methods for rapid full disclosure can be adopted. Remember, communication is a cornerstone of scientific innovation.

Related Articles: Many NIH-funded clinical trials go unpublished over 2 years after completion