Tuesday, 11 November 2014
Corruption crackdown targets doctors running clinical trials
by Michael Woodhead
Senior doctors who accept drug company money to run clinical trials are to be reined in by new health ministry regulations that aim to clean up the potentially unethical and corrupt practices and make clinical research more ordered and accountable.
The National Health and Family Planning Commission has released a new position statement entitled "Administrative Measures for the Clinical Study Projects of Medical Institutions" which will force clinical trials to be run under the auspices of hospital research committees rather than individual doctors or their departments.
The new rules stipulate that to clinical trials will be co-ordinated by a Clinical Study Administration Committee in hospitals, and funding for trials from industry will be channelled through hospitals rather than a particular department or individual doctor.
The study committee will have to set standards and procedures for administering clinical trials and maintain constant supervision of studies. Each trial will need to have a full record and documentation of its aims, protocols and the researchers involved. There will also be strict rules about the financing of trials and bans on having industry paying for or accepting "expenses".