The Dutch Central Committee for Medical Research on Human Materials (CCMO) has drawn up a directive on the evaluation of trail clinical agreements. Companies may have to adapt their clinical trial agreements accordingly. This is why the CMO has decided to establish conditions for: (i) provisions in the early termination agreements and (ii) provisions in the agreements to advertise research results. The CCMO wants to prevent the independent publication of negative research results from being blocked by either party, even if delays are still possible. B for patent reasons. In addition, opportunities to end research prematurely are limited and subject to strict rules. Contracts can no longer be terminated prematurely, for example. B because of the sponsor`s purely (commercial) interest in search results. The directive will come into force on 1 January 2009. From that date, ethics committees will verify compliance with the CCMO Directive through clinical trial agreements.
In accordance with the directive, the evaluation of clinical trail agreements between the promoter and the examiner by medical research ethics committees is mandatory. This assessment will be included in the evaluation of the ethics committee`s research file. The Ethics Committee cannot approve a proposed clinical trial if the agreement does not comply with the CCMO Directive. The CCMO found that, in many clinical trial agreements, the provisions relating to premature termination and publication of the results of the study were not in the interests of subjects and/or science. Please fill out this form, we will try to respond as soon as possible. Please copy this integration script and add it where you „I am a regular lexology reader, like some of my colleagues. I find the flow of information via email useful and good quality, and in some cases directly on point with questions that concern the company. It is important to stay abreast of legal developments and the articles are of great help in achieving this goal.
The ability to access items at no cost is essential, and I hope that lexology will continue with the right work. »
Neueste Kommentare