I recently noticed that for the approval of the new drugs (NDA) and biological products (BLA), the information about the approval process was published on FDA's website and in very timely fashion. Just a year ago, the FDA review/approval process regarding a new product was still not transparent to the public. We may be able to find some information on label, approval letter, and SBA (summary basis of approval); however, there were typically months or years after the approval.
Now, for the new approvals, not only the label, approval letter, and SBA, but also reviews from different perspectives (medical, statistical, pharmacology, enrivomental, CMC,...) as well as the administrative documents and correspondence between the FDA and the sponsor may be posted on FDA's website. Also listed or published is the list of FDA's officers who participated in the review and the decision making. The individuals from the sponsor's side may also be listed in some documents or correpondence.
This is obviously the outcome of FDA's initiative on transparency. "In June 2009, Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg launched FDA's Transparency Initiative and formed an internal task force to develop recommendations for making useful and understandable information about FDA activities and decision-making more readily available to the public, in a timely manner and in a user-friendly format."
To feel these changes, we can just take a look at two products recently approved by FDA: one by CDER and one by CBER. Don't forget to visit "Administrative Document(s) and Correspondence" or "Approval History, Letters, Reviews, and Related Documents".
This is a good sign that FDA's drug approval process is being demystified and moving to the transparency.
3 comments:
Dear Mr. Chunquin, thank you for such an interesting and clear blog, it's pleasure to read it! I am a Spanish Translator specialized in translating Medical Protocols (I will be lecturing in NY on October 2nd) and I would like to know your opinion about the need of the statistics section in the protocols. Is it necessary? Does anyone involved (patient, physician, investigator) understand it? I think that information should remain in the SAP. Regards from Valladolid, Spain
I don't think you can omit the statistics section from the protocol. The protocol is also for regulatory agencies and EC/IRB. They need to assess whether or not the statistical analysis for study endpoints (especially the primary endpoint) is adequate. With the public demanding more transparency in conducting the clinical trials, this is more critical than ever. The statistics section in the protocol defines the pre-specified analyses to prevent the people from doing the analyses purely post-hoc or data driven.
My understanding is the statistics section should be concise in the protocol and the SAP will provide the details.
I would like to add here that Statistics section in NIH funded research protocol is now being summarized in the section called Research Strategy. The role of Statistics and statistician now is more apt to be labelled as that of Research Methodologist- comprising of not just the statistical tools, but also. Design, ethics, and every thing else involved with research coordination. Much of outright dislike for statistics in Biomedical research is a result of a lack of fundamental understanding of what statistics really is as a science as well as an art particularly as it applies to clinical research settings.please Check papers by Steven
Goodman of John Hopkins. Thanks
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