Citation: Krishnan E (2005) Unregistered Trials Are Unethical. PLoS Med 2(2): e48. https://doi.org/10.1371/journal.pmed.0020048
Published: February 22, 2005
Copyright: © 2005 Eswar Krishnan. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Competing interests: I continue to work with the pharmaceutical industry in developing clinical protocols and enrolling patients for clinical trials. I have received monetary compensation for consulting for this activity.
Current journal requirements forcing clinical trials to be registered [1] are insufficient and are unlikely to solve the problem of negative trials never even making it to a journal. Most of the patients consenting to clinical trials do so out of altruism. It is a great betrayal of their trust to suppress clinical trial data. I suggest that institutional review boards refuse to allow human experimentation unless the protocol is filed in a central (online) repository. The primary data should also be required to be in the public domain (say, within 1–2 years after completion). Data obtained by appealing to altrusitic instincts, similar to money in public charities, are not proprietary information, nor can physicians cash out the trust of their patients. In reality, it is the pharmaceutical industry that stands to gain the most if data are made public as such data inform future research and help smaller, innovative companies avoid redundancy. Voluntarily sticking to higher standards of ethics will raise societal respect for the industry (currently being battered for greed) and attract a more talented workforce, and may even help the current efforts to reform the tort law.