2.01 Trials must be registred and results published
The research results of clinical trials and tests of the effect and action on the human body of medicinal products (pharmacodynamic trials) must be made public, irrespective of whether they show positive or negative results.
However, the results of trials to describe how a medicinal product is absorbed and excreted by the body (pharmacokinetic trials) is a part of the confidential material the firms make available to the authorities in connection with marketing authorisations and safety reporting.
Since 1 July 2005, the pharmaceutical industry has registered trials when they are initiated and, together with the results from the completed trials, the information will be published in electronic databases open to the public. The electronic databases are a supplement to the requirements laid down by law. The statutory requirements entail that irrespective of the nature of the clinical trial it must be approved by a scientific ethical committee as well as the Danish Medicines Agency.
Besides, Lif prepares and publishes a list of databases used by Lif members for registration of trials and publication of trial results. Click here to see the list
The principle of the Declaration of Helsinki to the effect that both positive and negative results must be published is now enshrined in the Danish Act on a Scientific Ethical Committee System since the scientific ethical committee may only grant permission if the results of the trial are published. The same provision is included in the cooperation agreement which the Danish Medical Association (DADL) and the Danish Association of the Pharmaceutical Industry (Lif) have signed concerning the conduct of clinical trials.
Lif sees it as crucial that the aim of the DADL-Lif cooperation agreement to ensure that there is no conceivable doubt as to the independence of the parties and the quality of the experimental work, is respected and sustained. Thus, it is important that there is a clear task and role sharing between companies, researchers and authorities. This task sharing will not be changed by the decision concerning public access to trial results.
Companies and researchers must submit all knowledge gathered in clinical trials to the Danish Medicines Agency which together with the scientific ethical committee have authorised the conduct of the trial. The reason for this is to protect patients and the general public from any knowledge being kept secret – with or without intention – and, at the same time, the authorities may stop trials or ask for supplementary information or investigations.
Lif supports the work of the scientific ethical committees because they ensure that the trials are meaningful before patients are subjected to new treatments or new trials.
Lif believes:
- that clinical trials must be registered and the trial results be made public,
- that each individual enterprise should draw up the required internal guidelines to ensure that the international guidelines are observed,
- that it is up to the enterprises to decide which databases to use for registration and publication.
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