The CCMO Public Register
Transparency on medical research is crucial to keep the public trust and the participation of healthy volunteers and patients in clinical trials. More and more patients and their relatives search for clinical trials in which patients can participate. With their participation these patients contribute to the increase of insights in diseases and new treatments.
In order to be able to meet these wishes of the society, core information of reviewed studies from the CCMO
National Register is published via the CCMO Public Register. The ABR form is the source of the core information that is released. The information is incorporated in the Public Register once the CCMO has received the decision of the reviewing MREC and the sponsor has not requested the CCMO to refrain from publishing the data.
Core information from Phase I studies with healthy volunteers is made public by the CCMO six months after completion of the review. Since December 2015 it is also mandatory to register the results of the study on the webportal ToetsingOnline (ReviewOnline) which will be made public in the CCMO Public Register if the sponsor has not objected to this.
In 2005 the International Committee of Medical Journal Editors (ICMJE) announced that the associated journals will require registration in a public trials registry as a condition of considering a manuscript concerning clinical trial data for publication. The trial must be registered at or before the onset of patient enrollment. The ICMJE only recognize registers that are accredited by the World Health Organization (WHO).
The CCMO has a memorandum of understanding with the Dutch National Trial Register (Primary register accredited by WHO) to merge the two registers to one new Dutch Primary National Trial Register. Until then additional registration of a trial at a WHO accredited trial register is still required.
There are several options such as Clinicaltrials.gov, EU Clinical Trial Register (for trials with medicinal products with one or more EU member states), or Nederlands Trial Register. Once the new Primary National Trial Register is available, submission of the ABR-form in ToetsingOnline suffice for the ICMJE and additional registration in one of the above registers is no longer necessary.
As of 1 July 2018 manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement. Clinical trials that begin enrolling participants on or after 1 January 2019 must include a data sharing plan in the trial's registration. More information can be found on the ICMJ website. At this site you can leave your email address to receive an email when the ICMJE updates its recommendations.