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Unregistered trials are Unethical

Posted by plosmedicine on 30 Mar 2009 at 04:38 GMT

Author: Eswar Krishnan MD MPH
Position: Practising Rheumatologist
Institution: Arthritis & Osteoporosis Center, Reading PA
Submitted Date: December 02, 2004
Published Date: December 7, 2004
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

Current journal requiremens forcing clinical trials to be registered is insufficient and is unlikely to solve the problem of negative trials never even making it to the a journal.

Most of the patients consenting to clinical trial do so out of altruism. It is a great betrayal of their trust to suppress clinical trial data. I suggest that IRBs refuse to allow human experimentation unless the protocol is filed in a central (online)repository.The primary data should also be required to be on public domain (say after 1-2 years after completion).

Data obtained by appealing to altrusitic insticts, similar to money in public charities, are not proprietray 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 were made public as it informs 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), attract more talented workforce and may even help the current efforts to reform the tort law.

Competing interests declared: I continue to work with the Pharmaceutical Industry in developing clinical protocols and enroling patients for clinical trials. I have recieved monetary compensation for consulting for this activity.