The data bank, managed by the National Institutes of Health (NIH)/National Library of Medicine, requires trial sponsors to register applicable clinical trials within 21 days after the first human subject is enrolled and submit certain summary results information for those trials, generally no later than one year after the study’s completion date unless a deadline extension is obtained.

That's really not a high bar to jump but the goal is simply to provide greater transparency regarding clinical trials, ultimately allowing the broader scientific community to build on the information submitted. Participants are volunteers who participate in research to advance medical science and enhances public trust - posting trial criteria and results creates a transparent and robust public record of clinical trials and information about their results.

Yet not all organizations follow through and FDA has sent over 40 Pre-Notices of Noncompliance to encourage voluntary compliance with the requirements.

Only one has refused.

That is why Acceleron Pharma has made history as the first company unwilling to honor even the most basic requirement of a clinical trial.  They said they wanted to evaluate the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma.  Instead they evaluated the force of the federal government.

Because they won't even do the minimum, FDA issued its first Notice of Noncompliance to them. Congratulations to the Acceleron government relations group for doing something no other company has done in the past.

Now they have 30 days to submit the required summary results information. If not, FDA will hit them where it really matters: money.