In September of last year a new set of rules related to the registration of clinical trial protocols and results on ClinicalTrials.gov, known as the 21st Century Cures Law, were passed by the US government. These laws came into effect on January 18 2017 with a 90 day grace period.
This update expands requirements for the submission of clinical trial registration and results information to the ClinicalTrials.gov, the NIH’s online trial registry. Specifically “this final rule… specifies how data that were collected and analyzed in accordance with a clinical trial's protocol are submitted to ClinicalTrials.gov”.
After reading through the official documents, two points stuck out to me as interesting discussion pieces for the industry. One is on the language around levying penalties for uncompliant sponsors – this I will cover in my next blog post. The second point I’ll discuss below is the language around a “responsible party” which delineates a concept that has been a longstanding gray area in the trial investigation process.
“Responsible party” is a special phrase reserved for use by parents of teenagers and US legislators. In both scenarios it’s going to be followed by someone needing to watch their behavior. In this case, it’s clinical trial sponsors.
The new laws states “there must be one (and only one) responsible party for purposes of submitting information about an applicable clinical trial. The sponsor of an applicable clinical trial will be considered the responsible party, unless and until the sponsor designates a qualified principal investigator as the responsible party. This final rule specifies the approach for determining who will be considered the sponsor of an applicable clinical trial under various conditions”.
This means we now have a clearer definition of who the sponsor of the trial should be. The reason this was a gray area before is because if an industry sponsor provided a grant to a Principal Investigator at a clinic or academic site, the study was codified as an academic study. Moving forward the sole sponsor is the company that provides the funding, given they have applied for the IND or IDE. However if the IND/IDE has been handled by the PI, the PI will remain as the sponsoring party. Follow this link to the section of the documentation that describes the matter in detail.
A Shift Is Coming
Of the near 240,000 trials now registered in ClinicalTrials.Gov, about two-thirds are registered with academic sponsors, and one-quarter (28% to be exact) are initiated by industry as shown below in adjacent graph. This is a phenomenon we’ve documented before in our post Is Academia Beating the Industry in Number of New Trials Per Year.
With the new legislation almost out of its grace period, we anticipate to see a shift towards more industry sponsored studies since the industry can’t “hide” behind a principal investigator sponsored trial. We will track how the sponsor-type composition of new trials changes in the coming year.
Subscribe to our blog to get more posts about industry news trends insight. In the coming weeks we will be sharing information about the penalties clause discussed in the new Cures Law. Coming up, we will also discuss a new ClinicalTrials.gov interface the NIH has released into beta.