With the launch of our FDAAA TrialsTracker, applicable trials that have failed to report their results on ClinicalTrials.gov are starting to appear. If you go here on our Tracker (the “All Trials” view, and toggle the “due” filter) you can see all the trials that have not yet reported.
Non-reporting of clinical trial results in an ongoing, global public health issue. We are going to start highlighting some of these unreported trials in blog posts to shine a light on what information is being withheld from the public as a result of non-reporting.
As this is our first trial profile since the launch of the tracker, we’ve also taken a closer look at why, exactly, we think this trial is due to report in another blog post.
Today’s trial is “Comparison of Fentanyl-bupivacaine and Clonidine-bupivacaine for Breakthrough Pain in Advanced Labor in Patients With Continuous Epidural Analgesia” (NCT01846221). It is a Phase 4 study, meaning it is being conducted on drugs already approved for marketing by the FDA. The trial is designed to investigate whether there is any difference between two different strategies for managing severe pain in women during childbirth, specifically late stage “breakthrough” pain as the baby begins to make its way through the pelvis. If you’ve ever had children, you may be familiar with the option for mothers to receive an epidural during labor. This is a continuous infusion of drugs to help manage the pain associated with childbirth. If women further experience “breakthrough” pain, additional treatment beyond the initial epidural may be necessary. In this trial, the investigators are examining two drug combinations, commonly used in their medical center, to see which works best for managing “breakthrough” pain during labor.
This trial enrolled 101 women randomized to receive either Fentanyl-bupivacaine or Clonidine-bupivacaine, two different drug combinations used in anaesthesia to help manage pain. The primary outcome is patient self-assessments regarding their pain levels. Secondary outcomes include measures examining the health of the mother and newborn as well as the ultimate method of delivery (vaginal vs cesarean).
According to ClinicalTrials.gov, this study was sponsored by Columbia University and conducted at their medical center in New York City. The PI is Dr. Allison Lee, who took responsibility for maintaining the study record.
This is an important trial, and the investigators are to be applauded for conducting it: we know from our own team’s work that RCTs are a challenging group activity. However, unfortunately, this trial has not reported its results on ClinicalTrials.gov. As a consequence doctors, expectant mothers, and patients cannot access the results, nor use them to make choices about treatments. The results are similarly inaccessible to commissioners of health services, and policymakers, who might make decisions about hospital resources; and to researchers, who would help to put the findings in the context of other research on the same issues.
In addition, we can find no indication on either Google or Pubmed to show that this trial has been published elsewhere, in the grey literature, or an academic paper. That is unfortunate. This trial is interesting and important work that will be useful for obstetricians, and mothers, worldwide. We hope the results will be reported on ClinicalTrials.gov soon!
We will be doing more spotlights on unreported trials in the future. If there is an unreported trial you have found, that you find particularly interesting, please do get in touch. We’d be happy to put it on our list to write on.
-Ben Goldacre and Nick DeVito