FDA Posts Full Clinical Study Report for NDA for Novel Products 
​​[Posted on: Thursday, March 22, 2018]

This week FDA posted a full clinical study report (CSR) included in an NDA approved last month for prostate cancer drug ERLEADA. In this new pilot transparency program FDA plans to similarly publish CSRs for eight more newly approved drugs aiming to provide more usable information about clinical trial design, statistical analysis, and other operational aspects of successful clinical trials to other companies developing similar drugs. The portions of the CSR that was posted include information from the CSR body, the protocol and amendments, and the statistical analysis plan (SAP) for the study. FDA redacted trade secret and other proprietary information but these disclosures are remarkable in the significant details that are available to the public. Traditionally, when FDA approves any new drug, it posts on its website the review summaries from the various sections of the NDA which help other developers understand the data submitted in support of the application. These review summaries contain a wealth of information on the overall design of the program, the questions asked by the reviewers and the strategies adopted by the applicant. With this new transparency initiative, FDA plans to go further and publish the full clinical trial protocols and the results submitted in the CSR, along with the associated SAP. FDA will not publish the raw data and additional information will be posted only for the pivotal studies. For example, for ERLEADA, the sponsor conducted three clinical trials (one proof of concept, one QT/QTc, and one pivotal) but the CSR, protocol and SAP were only posted for the pivotal study. This was a 505(b)(2) drug. Based on the announcement, all 9 applications selected for the pilot program will be for drugs, not biologics. The additional information is posted on the same page as the page containing the other review summaries. FDA also identified the clinicaltrials.gov registration number. A review of the clinicaltrials.gov page for the trial whose CSR was posted can be used as a textbook example of the errors on clinicaltrials.gov postings. The same trial was listed as “Active” on its clinicaltrials.gov page as of 8th Feb 2018, six days before the approval of the NDA; according the CSR, the study was completed on 19th May 2017. Clearly the sponsor did not update the clinicaltrials.gov information for the trial and the accuracy of clinicaltrials.gov posting was not verified by FDA. This transparency initiative is first of its kind in the World. FDA would seek permission from the sponsors whose applications are selected for disclosure; FDA’s announcement indicates that the sponsors “wish to participate in the pilot”. After completing the pilot program, FDA will seek public comments before making it permanent. Similar program is being considered by European Medicines Agency as well.