From Pediatric Trials found on ClinicalTrials.gov

From Pediatric Trials found on ClinicalTrials.gov

There was an article recently published in Outsource-Pharma by Melissa Fassbender titled Study: Pediatric Clinical Trials Are Failing to Inform Science. The article describes a study that exposed how 30% of the 599 pediatric trials at Boston Children’s Hospital remain unpublished in medical literature. As someone who is consistently diving into clinical trial data, I wanted to take a further look into the issue. What I found is that Fassbender exposes an issue much bigger than the article implies. When I looked at a sample of over 30,000 pediatric trials, the rate of failing to publish results was 87.5%! Here’s more on how I got to this number, and why it’s a problem.

About The 87.5%

The 30,000 trials I mentioned before were found on ClinicalTrials.gov (CT.g), the NIH’s online registry for clinical trials. The exact number of pediatric trials I found by using the advanced search tool was 33,637. Of these, 29,474 have no published results.

To get a better understanding of these trials I looked at their funder type, and found that 31% are industry funded. The rate of failing to publish results in these 10,574 trials is the lowest of any funding type, at 75%. Look at the breakdown below to see the rate for each funding type and keep in mind that “Other” is mostly medical and academic centers.

Click to Enlarge

Also, a quick note about the metric I used to get to 87.5%. Fassbender’s article looks at the number of trials that “remain unpublished in medical literature”. The number I used in my analysis looks at closed trials without published results. These are comparable because in order for an investigator to publish something about a trial in medical literature, they must have results about the trial on records with CT.g. Whether or not this is enforced is a different question, as is the case for other data-sharing regulations around clinical trials.

The Implications

The results of the above Boston Children’s Hospital study found more than 69,000 children that participated in the trials that were completed but were never published in scientific literature.  “As a result, these trials fail to contribute to our scientific knowledge and to inform the clinical care we can provide to children”.

I believe that incomplete, inaccurate, misleading, or delayed reporting of medical research may result in poorly informed decision making and reduce the efficiency and quality of health care. Therefore, scientific and clinical research should be reported in a complete, accurate, and timely manner.  The problem is exacerbated in pediatric trials as children may respond differently to new drugs on the market. The overall process in pediatric trials is more delicate. Research has to be conducted differently and drugs have to be tailored for their unique physiology.

Today there are 4,173 pediatric trials with posted results. The investigators involved did their part by completing the trial process and sharing what they learned with the medical community. Because of this, future pediatric trial coordinators can learn from work that has already been produced, and the advancement of health care has accelerated, even if slightly. But almost 41,000 pediatric trials haven’t completed the final step of the process; posting their results on CT.g. For those keeping score at home that’s over 10x the current amount.

If clinical data sharing was widely practiced, we could be informing present and future clinical trial teams with a volume of data over 10x of what we have today. We should be making greater developments in pediatric healthcare through proper data-sharing practices. 

2 Comments