Pharma has offered several suggestions for effectively maintaining corporate confidentiality without cost to consumer interests.
The majority of these suggestions involve limiting the information published at trial initiation regarding clinical-trial
design. This would mean delaying the posting of certain pieces of information until the company can reasonably file for intellectual-property
protection or publish an article in a referred journal.
In this scenario, the company's need to protect proprietary information could easily be balanced with the public's desire
for disclosure. Companies could be required to publicly register an outline or overview to be updated as the trial progresses.
In coordination with this effort, the complete protocol could be filed with a disinterested third party. This third party
would maintain confidentiality until the study is completed or terminated. Because the clinical-trial endpoints are defined
up front in the protocol, companies could not selectively disclose trial results. Therefore, the public gets access to the
desired information while the companies maintain the necessary level of confidentiality.
This solution maintains the original intent of trial registries and databases—sharing meaningful trial information with the
public. The desired transparency is created, but at a time that would allow proprietary information to remain just that. This
protection is critical to ensuring continued investment of billions of dollars in R&D by the pharma industry.
Expense The increased availability of information creates the desired transparency, but at a price. Pharma companies must bear registry
and database setup and maintenance costs while finding a way to manage the potential avalanche of questions from healthcare
professionals and consumers. Costs associated with implementation, maintenance, and managing public feedback could be staggering.
However, managing public opinion is increasingly important to pharma companies. After all, it is the public that ultimately
purchases pharmaceutical products.
As with any new endeavor, companies must proceed within well-defined parameters to define what will fit best with their overall
business objectives. Creating a more comprehensive registry should result in increased public trust, greater clinical-trial
participation, and enhanced consumer welfare.
Lisa Grimes is a member of the executive advisory group for Campbell Alliance. She can be reached at email@example.com