New Cooperation Agreement on clinical trials and non-interventional studies

The members of the Danish Medical Association and Danish Association of the Pharmaceutical Industry (Lif) have adopted a new cooperation agreement on clinical trials and non-interventional studies. The purpose of the cooperation agreement is to ensure high ethical standards and to pro­vide unambiguous guidelines for the cooperation between physicians and the pharmaceutical industry when clinical trials or non-interventional studies are conducted.

The new cooperation agreement (the "Agreement") replaces the former cooperation agreement on clinical trials between the two parties of 8 February 2006.

Clinical trials

As in the former agreement, the Agreement states that all clinical trials must be monitored and audited in con­formity with the Danish regulation on clinical trials as well as the Helsinki Declaration, WHO's clinical Trials Registry Platform and regulation on Good Clinical Prac­tice in general.

Non-interventional studies

Contrary to the former cooperation agreement, the Agreement also regulates non-interventional studies. Before conducting a non-interventional study the phar­maceutical company and the investigator must prepare a study plan. The study plan must be sent to the Danish Medicines Agency ("DMA") requesting the DMA to decide whether the study is an interventional trial or a non-interventional study as well as requesting the DMA to confirm that the study is in conformity with the regula­tion on advertising for pharmaceutical products.

Mandatory requirement for a written contract

When conducting a clinical trial or a non-interventional study the pharmaceutical company and the investigator must enter into a written contract and both parties must sign the trial protocol or study plan.

The written contract must describe both parties' assign­ments, duties, responsibilities and rights in relation to the trial/study. If the pharmaceutical company is the sponsor of the trial/study, the written contract must stipulate the services, fees and other expenditure to be paid by the pharmaceutical company.

Publication of knowledge

The Agreement states that knowledge obtained through a clinical trial or a non-interventional study belongs to the public, ie all results should always be published whether the results are positive, negative or inconclu­sive. However, it is only the scientific quality of the com­pleted trial/study which should be published, and not the test results as such.

Possible ways of publication are regulated in details in the Agreement. Furthermore the Agreement states that all approved clinical trials must be notified to an officially approved and publicly accessible register, for example www.clinicaltrials.gov.

Scientific dishonesty

If one of the parties suspects scientific dishonesty, this must be reported to the Danish Committees concerning Scientific Dishonesty (UVVU).

The new cooperation agreement came into effect 31 May 2010.

Any questions to the new cooperation agreement can be directed to Mikkel Vittrup, Attorney-at-Law, mvi@plesner.com, or Annika Valla Broman, Attorney-at-Law, avb@plesner.com.