Recently, we received a letter from the principal investigator of a multicenter study, informing us of the withdrawal of their paper from consideration for publication. The study was an industry-sponsored study of a novel therapeutic approach for the treatment of hepatitis C. Receptive to well-performed early studies of new efforts in an area with dire therapeutic needs, HEPATOLOGY received the first version with interest. The reviewers pointed at the need to reach a different conclusion, pointing at the predominance of negative results and alternative explanations for the findings; the investigators thought the requests were reasonable. When the investigators contacted the sponsor, the pharmaceutical company did not accept such changes. Hence, the manuscript was withdrawn.
So, who owns the data? The answer is simple. The law states the database is propriety of the sponsor. But the episode cannot be dismissed. A clash between proprietary and intellectual rights is most unfortunate, a conflict which runs the risk of being improperly resolved. At a time when many new therapeutic approaches are planned for the treatment of liver disease, the events illustrate the casualties of an approach that hurts all parties involved.
The pharmaceutical company has much to lose. The sponsor invested resources and energy to see protocols completed. However, unpublished studies do not advance the cause of a new therapeutic agent. Such decisions risk a loss of credibility within the hepatological community for claims of the drug's effectiveness. Unable to attest to the purported benefits of the drug and having strained its relationship with the investigators, the pharmaceutical company will require renewed efforts and investment in order to establish the benefits of their approach.
The investigators also lose. They invested time and effort to carry out the study, a commitment ultimately rewarded by a solid publication. Obtaining the acceptance of a study in a peer-reviewed journal illustrates a certain quality of work and adds to the credentials of individual investigators. Thus, such publications require researchers to be involved in the planning, performance, interpretation, and submission of the research. Investigators who perform these steps wield intellectual property over the data.1 Commercial ownership of the database, although legally binding, cannot replace the impact of the intellectual analysis.
But the greatest casualties in this event are the patients. When humans volunteer to participate in clinical research, consent forms are signed and copies distributed. Underlying this contract is an altruistic motive that has fueled advances in clinical practice over many decades. The sense of satisfaction gained by participating in research studies is accompanied by a profound trust in the investigators who assume responsibility for the study. I imagine the dismay of patients, who having accepted the unknown risks of a new treatment, witness the shattering of their trust when their efforts are misspent. Nonpublication of data is a betrayal of trust.2
This discussion arises at a time of increasing scrutiny of the fate of nonpublished clinical studies. The International Committee of Medical Journal Editors has mandated registration of clinical trials by July 1, 2005, such that nonregistered studies will not be accepted for publication.3 HEPATOLOGY supports this statement and has agreed to institute such a policy. Its implementation awaits the designation of the registration site. We agree with the goals of full transparency in the publication of clinical research.
At the same time, the situation depicted in today's Corner highlights a limit for such policies. The sponsor has the legal authority to hold on to the data. But results obtained from human subjects cannot be viewed as simple pawns in a competitive environment. In fact, it has been recently proposed that research ethics committees assess public dissemination of results of clinical studies,4 extending their role to protect the rights of research subjects. With ownership comes responsibility. And responsible clinical investigation culminates in the presentation of data in peer-reviewed publications.