News

2009-11-25 Increased access to clinical research data

Polish Ministry of Health is elaborating changes in regulations regarding clinical research. One of the main points suppose to be an increase in their disclosure.

Most probably Polish website on clinical research will be formed alike as the American source of information on the subject: www.clinicaltrials.gov. The portal contains data of research description, its sponsor, place of research and group of patients included in the trial.

Representatives of CRO companies, which conduct studies on order of the sponsors, do not see any obstacles in increasing transparency in the field.
Ireneusz Otulski from Lambda Therapeutic Research said – “The problem of the current system is not the lack of openness but the fact it operates only locally. Information on clinical trials carried in Poland is accessible on American website but not in the Polish national registry, because data of Polish Central Evidence of Clinical Research is not publicly available.

Additionally, clinical studies sponsors are not against partial disclosure of the carried projects. “Clinical studies should be more transparent than today” – said Mariusz Borkowski, Bioton SA. However, he adds that the publicly open information needs to be limited to such data as: subject of study, its aim, methodology, main coordinator. The reason is avoidance of intellectual property disclosure and of external conditions influence.

As a result of an easy access to information on the carried clinical projects, patients will have opportunity of applying individually to chosen medical units for treatment with a new drug.

Magdalena Zychlinska-Jackiewicz