Which Current Regulatory Issue Keeps You Up At Night?


Applied Clinical Trials

In a recent survey, the results of which I will be presenting at CBI’s Forum on Phase II-III Clinical Study Optimization in Chicago on Thursday and Friday, we asked "Which ONE current regulatory issue keeps you awake at night?" And, as you can see in the chart, the top one, at 33% was making sure that the sponsor's clinical trials is registered in all the countries that is required. And that is no small task. Besides the fact that clinical trials have to be registered multiple times, in multiple systems globally, now some medical journals have published articles and editorials on the missing data that goes unpublished either in these registry web sites, or in general.

And this is interesting also in that CBI has offered a forum on Clinical Trial Registries and Results Databases for the past seven years. And I attended one of them in early 2009, which was soon after the FDA's required deadline for the implementation of clinical trials results requirements on ClinicalTrials.gov. I learned a lot at that conference about the challenges of ClinicalTrials.gov from a sponsor point of view. At that time, Nicholas Ide, the chief architect of ClinicalTrials.gov said of the 250-plus results submitted to the database, only 46 had been published to the web site and the rest had been sent back to sponsors with queries and comments on the data. Which Ide had said at the time "The data we have been getting is difficult to understand and the quality is pretty bad."

Which, personally, I don’t think is a sponsor problem. When taking information from one system/database or platform and inputting into another system/database or platform, and then not knowing exactly what Ide et al., are looking for in the data, well, it's a bunch of people wanting different things and not being able to articulate it. Whatever the word is for that.

Anyway, since that time, three years ago, ClinicalTrials.gov as I mentioned has taken some criticism. The March 3, 2011 issue of the New England Journal of Medicine published "The Clinical Trials.gov Results Database;" "Update and Key Issues;" and one of the authors was Nicholas Ide. In the article, they note that a growing number of researchers were using ClinicalTrials.gov for analyzing trends in globalization of the clinical research enterprise; selective publication of study results and correspondence levels between registered and published outcome measures.
But the authors also caution about the limitations of ClinicalTrials.gov trials that aren't required to be registered; missing records of information based on imprecise entries and human error; and new policies in registry and registration worldwide.

This past August, four members of Congress introduced a bill, the Trial and Experimental Studies Transparency or TEST Act of 2012 to address what they term clinical trial loopholes in ClinicalTrials.gov. And the major issue is the TEST Act updates and expands the clinical trial registry data bank – ClinicalTrials.gov – with stronger reporting requirements, and requires that all foreign clinical studies meet the same requirements as domestic trials if they are used to support an application for marketing in the United States.

We aren’t sure when this Act goes on to the next step, but we are sure that registries and results databases and all the surrounding implications will continue to be in the news.

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