Industry Responding as Best It Can
The pharmaceutical industry has made many significant changes to both its public face and its internal business processes
in order to comply with the spirit and the letter of the emerging regulations. In January 2005, in response to the early trial
registration initiatives and perhaps in anticipation of regulation on results, the leading biopharma industry associations
published the "Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases."
This gave rise to
http://csr.org/), a Web portal for results disclosure. The position statement also committed member companies to register all non-exploratory
clinical trials, and to disclose a results summary in ICH-E3 format within one year of study completion for trials of approved
drugs, or within one year of first commercial availability. The only exception would be if such disclosure would compromise
publication in a peer-reviewed journal.
It's also worth noting that seven of the top 10 biopharma companies see public disclosure as important enough to warrant a
link from their corporate home page, and most have placed a public statement of their disclosure practices on their Web site.
Many have also replicated their trial registry and results disclosure information directly on their corporate Web site, thereby
showing a public commitment to the process. (See "Big Pharma's Registry Response")
Big Pharma Registry Response
However, adhering to the process has been a struggle for the industry. Although biopharma companies are now reallocating staff
and funding to manage the process, many are finding it challenging to remain in compliance when it comes to providing data
in the required time frame. This will only worsen as the weight and complexity of the mandate to publish or perish grows.
Other challenges include:
Lack of harmonization Global harmonization of clinical trials registration is a challenge at many levels, particularly when it comes to what data
are to be reported, when, and how sponsors can interact with the Web portals.
The World Health Organization (WHO) hopes to establish a number of harmonization initiatives surrounding the disclosure of
clinical trial results, including norms for data elements and responsible parties, a network of primary trial and results
registers, a one-stop "meta-search engine" that can search across all global registries in the WHO network, and a mechanism
for a single, unique-trial identification number to avoid confusion among site searchers. However, these measures appear to
be moving at a much slower pace than the emergence of new national or regional clinical data disclosure initiatives.
Challenge to peer-reviewed publication process Publication in peer-reviewed biomedical journals remains one of the most respected channels of novel clinical findings from
sponsor to physicians. However, the current requirement to post trial results within 12 months of "last patient, last visit"
has put increasing pressure on the peer-reviewed journal publication processes.
Current data analysis and internal reporting processes, combined with often lengthy peer review and publication lead times,
make it almost impossible to secure primary publication of clinical trial results prior to the obligation to post within the
12-month deadline. If the industry and medical journals want to see clinical trial results first published in peer-reviewed
publications, they need to reduce cycle times so that primary publication might precede registry posting.
Concerns over the "non-promotional" public summaries As early as September 2010, FDAAA will require trial sponsors to post a "non-promotional summary" of each trial and its results
expressed for both technical and lay audiences as part of the disclosure requirements. But compliance is fraught with challenges.
After all, is it considered promotional if a company states that the trial met its endpoint and confirmed that the intervention
exceeded response by the comparator? Most stakeholders would prefer to see the first disclosure of new clinical findings in
a report that has been rigorously peer-reviewed, rather than one that is simply a synopsis of data.