Have you thought about researching clinical trial results? 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. But how can you find information on clinical trial results?
Researching clinical trial results 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 often leave out vital information which can complicate your treatment decisions.
Importantly, experts believe the results of “randomized clinical trials might not apply in a straightforward way to individual patients, even those within the trial.” In other words, differences between individuals can significantly affect the “likelihood of benefiting from or being harmed by a therapy”. Meaning, even if a trial proved a treatment is effective, there is no guarantee if will help, and not harm, you or a loved one.
The US government requires researchers to report clinical trial results.
A federal law requires researchers to publish clinical trial results in ClinicalTrials.gov within 1 year of completion of most research projects. The law was created after concerns that pharmaceutical companies hid evidence showing negative, sometimes very serious, side effects and reactions in trials. The law aims to provide accurate information that doctors and patients can use to learn about the safety and effectiveness of new treatments.
Do research institutions follow the reporting guidelines?
The good news is that there has been a significant improvement in reporting. The bad news is that there is still a lot of room for improvement. Unfortunately, many researchers do not report results as required, even after the enactment of a stronger law, effective January 2018. A recent investigation by Science found that many still ignore the requirement. Furthermore, federal officials do little or nothing to enforce compliance.
What did Science find during their investigation?
Science examined thousands of trials whose results should have been posted on the ClinicalTrials.gov website under the new 2017 rule. Although the reporting rates by most large pharmaceutical companies and some universities significantly improved, many other trial sponsors, including the NIH, fell short. The analysis found that 30 companies, universities or medical centers never met a single deadline. Who failed to report findings? Prominent institutions failed, including the Harvard University–affiliated Boston Children’s Hospital, the University of Minnesota, and Baylor College of Medicine. They also found that MD Anderson Cancer Center, the Mayo Clinic and Yale University repeatedly failed to report results on time, or at all. And, since these prominent institutions were among the top 50 recipients of NIH grants in 2019, the public is missing out on what could be important research findings.
Why is this a concern?
Inadequate reporting leaves doctors and patients in the dark, potentially leading to patient harm. For instance, if researchers found dangerous side effects with a medication, shouldn’t patients and doctors have access to that information? Conversely, if a new treatment shows great potential, shouldn’t patients know about it? Additionally, a lack of reporting can slow future research and medical advances.
The government isn’t enforcing the law.
Although the 2017 rule outlined aggressive enforcement and stiff penalties, neither the NIH nor the FDA has taken action on those who don’t comply. The FDA recently stated that it won’t impose penalties until they issue further “guidance” on how the process. To date, they have not imposed any fines. And they haven’t set a date when they’ll start. Furthermore, in 2016 the NIH said it would cut off grants to those ignoring trial reporting requirements, but failed to do so.
According to the Science report, experts estimate the FDA could have collected at least $6 billion in penalties from failure to publish timely results on ClinicalTrials.gov. And the NIH has never withheld a grant due to a failure to publish, even though the results from more than 2600 trials were overdue or filed late.
What’s the difference in reports on ClinicalTrials.gov and in scholarly journals?
ClinicalTrials.gov 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. Finally, thousands of trials are never published in scholarly journals, especially if they find treatments are ineffective.
Published results do not include all side effects.
No matter where you read clinical results, you should realize that some information on side effects might be omitted, even in respected medical journals. Clearly, this poses a problem for doctors and patients. Realize that all medications and treatments have potential side effects, but some are more dangerous than others. To make an educated treatment decision, it’s important to know all the possible side effects.
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 should 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 a few years!
What can you do when researching clinical trial results?
Use ClinicalTrials.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. But, realize the information you find may be incomplete. Keep in mind that even 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. You can ask about 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.
For more helpful information, read these posts:
- Can You Trust Advice from Other Patients?
- Understanding Medical Information Is Harder Than Most Realize.
- 10 Tips for a Better Medical Appointment.
- How Can You Get the Best Healthcare? Actively Participate!
- Can You Trust Medical Information Online?
- Should You Trust Your Doctor’s Recommendations?
- The Dangers of Too Many Tests and Treatments for Patients.
- The Importance of Shared Decision Making.
NOTE: I edited this post on 11-4-20.