The Dutch Central Committee on Medical Research Involving Human Subjects (CCMO) has drawn up a Directive on the Assessment of Clinical Trail Agreements. Companies may need to adjust their (template) clinical trial agreements accordingly.
Pursuant to the Directive the assessment of clinical trail agreements between sponsor and investigator by medical research ethics committees is obligatory. This assessment will be included in the ethics committee's over all assessment of the research dossier. The ethics committee may not approve a proposed clinical trial if the agreement does not comply with the CCMO Directive. The CCMO noted that in many clinical trial agreements, the provisions on early termination and on publication of study results were not in the interest of the trial subjects and/or science.
Therefore the CCMO decided to set out conditions with regard to: (i) provisions in agreements concerning premature termination of the research and (ii) provisions in agreements concerning the public disclosure of research results. The CCMO wants to prevent that independent publication of negative research results is blocked by one of the two parties involved, although delay e.g. for patent reasons remain possible. Furthermore the possibilities for premature termination of the research are limited and subjected to strict rules. Agreements may no longer be terminated prematurely because of e.g. mere diminished (commercial) interest of the sponsor for the results of the research.
The Directive comes into force on the 1st of January 2009. From that date onwards, ethics committees will review compliance of clinical trial agreements with the CCMO Directive.