IV. Benefits & Costs of Transparency

  1. Overview
  2. Defining Clinical Trial Transparency
  3. Clinical Trial Spin and Suppression
  4. Benefits and Costs of Transparency
  5. Legislative Strategies to Encourage Transparency
  6. Bottom-Up Strategies for Clinical Trial Transparency
  7. Conclusions: Towards Greater Transparency
  8. Clinical Trial Transparency References

As Part II showed, there are frequent deficiencies in the publication of clinical trial results.  Increasing the transparency of trial data brings benefits and risks that must be balanced.  Potential costs of enforcing transparency include the disclosure of valuable, proprietary information that belongs to study sponsors, the possibility that disclosure rules could have a chilling effect on all clinical research by encouraging torts, the risk that trial sponsors would change study locations to evade regulation, and the practical problem that more transparent clinical trial data could be misinterpreted by other researchers or by the public, leading to unjustified fears or confusion.

The first concern about transparency is the need for drug developers to maintain the confidentiality of their products and plans.  Today, this is the major justification for the FDA refusing to release clinical trial data in response to FOIA requests.  However, since the information is not released, it is difficult to assess whether it legitimately has proprietary business value, and the proprietary information label might well be applied liberally to stonewall those seeking information.  We can consider three ways in which trial data might be proprietary, but will find that these arguments are unlikely to be justified.  First, a trial protocol could contain proprietary data about the drug or device under investigation, such as the chemical structure of a new chemical entity, or a diagram of a novel implantable device.  Such information is clearly of proprietary value.   However, by the time that a product is actually in clinical trials, the patents to protect these novel drugs or devices would long since have been applied for.  Only in rare cases would a product contain trade secrets for which the manufacturer was not seeking patent protection.   Since a patent application would have already been submitted, releasing information about new products in documentation about clinical trials would not constitute disclosure or jeopardize issuance of the patent.  It is possible, however, that a provisional patent had been applied for but had not yet made public as a full application.  Given the relatively long time that it takes to plan and execute a clinical trial, this seems unlikely, as a provisional patent would become public within 18 months.  However, if the situation did arise, it would be reasonable to permit non-disclosure of data until either the provisional application became a full application and was published.

One of the most important concerns about research transparency is the risk of creating a disincentive to do any research at all, because having accessible information could create tort liabilities.  A company would prefer not to know about a safety risk at all, than to conduct a study and expose itself to being sued because of what is learned.  [30]  This “transparency paradox” must be addressed if measures to increase transparency are to be effective.   In [30], Cahoy proposes two approaches to neutralize the transparency paradox.  The first approach is to tightly connect information production to limitations on tort liability.  In return for generating and publicizing information about a trial, a company would obtain immunity from tort liability based on the release of that information.  Companies would still be able to keep information secret if they so chose, but their interests would be better aligned with that of the public, because not keeping some damning data secret would have the advantage of reducing their liability, in addition to benefiting the public interest.  One possible way to do this would be, as Cahoy suggests, to create a statutory exception in federal evidentiary law to exclude the results of a controlled clinical trial from cases filed after the disclosure that claim a design defect, failure-to-warn, or negligence.

Another potential risk of enforcing clinical trial transparency is that sponsors might move trials to different locations in which they were not subjected to such rules.  Such a move could again paradoxically reduce transparency, and would also raise the risk that trials might not be adequately supervised in other respects.  For example, the Institutional Review Boards in a developing country might not be as stringent, or research subjects might not be as well informed of trial risks.  Although there are international guidelines governing both trial conduct and publication of results, these guidelines, which written by organizations such as the WHO and UN committees, cannot be easily enforced.   The risk of trials actually moving due to regulation is likely overstated, however.  In order to be considered for US marketing approval by the FDA, trials must be performed to the same standards even if conducted overseas.  Moreover, the US remains one of the largest medical markets, and offers access to more potential research subjects and doctors than most other regions.  Since subject recruitment is often the major bottleneck in conducting clinical trials, it is unlikely that a trial sponsor would give up access to the US patient population, even if new regulations encouraging transparency were to make operating in the US more difficult.

05/18/2010 | Uncategorized | Comments

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