Are you trying to find information on new treatments?
When you, or a loved one, have a serious medical condition, it is natural, and important, to want to learn as much as you can about the condition and potential treatments. When traditional, often-used treatments are not promising, or not working for you or your loved one, it can be helpful to research new treatments that have recently been evaluated in clinical trials.
Researching clinical trial findings can be tricky.
Clinical trial reports can help you learn about new treatments that could be worth discussing with your doctor. However, it is important to realize that research do not always publish results as quickly as required. Also, the published results leave out vital information which can complicate your treatment decisions.
Legal reporting requirements are set by the US government.
A federal law requires clinical trial results to be published in ClinicalTrials.gov (a government database) within one year of completion of the research. You can use CinicalTrials.gov, to research the effectiveness of approved and experimental drugs and devices. You can also learn about side effects, including some that may be life-threatening.
Why is this reporting required?
The US government adopted this rule in 2008 after learning of many cases in which companies allegedly hid evidence showing negative, sometimes very serious, side effects and reactions in trials.
What are the benefits of ClinicalTrials.gov?
This site is a universal, free, and open repository for all human studies. In comparison, scholarly journals only publish a select group of results and charge subscription fees that many patients find too expensive. Additionally, scholarly journals do not have easy-to-compare formats, making it harder for patients and doctors to compare studies.
How often do research institutions report clinical trial results to ClinicalTrials.gov?
The good news is that there has been a significant improvement in reporting in the past 2 years. The bad news is that there is still a lot of room for improvement.
A 2015 STAT investigation found that although reporting issues are decreasing, many leading research institutions fell far short of the requirements:
- Overall, researchers reported required results 72% of the time in 2017, compared to 58% in 2015.
- Research institutions cited for bad reporting two years ago made many of the biggest improvements. This includes Memorial Sloan Kettering Cancer Center, the University of Pittsburgh, and Stanford University.
- Reporting by major research universities jumped significantly, from 58% to 77% of trials. Reporting by drug and device companies improved more modestly.
- 40% of trials reported results after the legal deadline of 1 year following the completion of the trial.
This inadequate reporting can lead to patient harm and can slow future research and medical advances.
Published results do not include all side effects.
Although all medications and treatments have potential side effects, some are more dangerous than others. To make an educated treatment decision, it’s important to know all the possible side effects. This can be difficult because clinical trial reports don’t always accurately report side effects, even when published in respected medical journals.
The authors of a 2016 report about clinical trial reporting stated that “there is strong evidence that much of the information on adverse events remains unpublished and that the number and range of adverse events is higher in unpublished than in published versions of the same study.” Their analysis found that on average, 64% of side effects were not included in published articles. This includes the omission of serious side effects such as death, suicide, and/or dangerous respiratory problems.
This report worry doctors and patients. The authors state they “identified serious concerns about the substantial amount of unpublished adverse events data that may be difficult to access or ‘hidden’ from health care workers and members of the public.”
Hopefully the number of unreported side effects has decreased since this 2016 report. However, it is hard to imagine the research community eliminating this problem in such a short time!
What can you do?
Use ClinicalTrials.gov as a resource but realize that the information you find may be incomplete. Keep in mind that your doctor might not have complete information on new treatments, including all potential side effects.
It may be helpful to reach out to groups of patients with similar conditions to learn of their experiences with particular treatments but realize this is hearsay and not medical opinion. If interested, you can find support groups and group chats by searching online.