Clinical trials on medicinal products for human use

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EGSZB-vélemény: Clinical trials on medicinal products for human use

See EESC opinion in all languages under Related documents at the end of this page.

 

Key points:

The EESC:

  • recognises that clinical research is an essential and continually developing area of scientific endeavour with the goal of understanding diseases and developing medicines for patients;
  • stresses that the protection of subjects from unreasonable risks and burdens has to be fully taken into account and the welfare of the individual subjects must take precedence over all other interests;
  • considers that, given how science and technology are developing and given their impact on the way trials will be conducted and products tested in clinical trials in the future, it makes sense that strong provision be made to periodically assess and if necessary amend the Regulation;
  • calls for the establishment of a single EU governance area for clinical trials;
  • welcomes and strongly defends the implementation and use of a single portal for both multinational and single country clinical trials without the need to further code data into any of the national systems;
  • calls for explicit inclusion in the Regulation of assessments by the independent ethics committee;
  • calls for the EU to support and facilitate cooperation and the exchange of scientific information among Member States within a network connecting ethics committees designated by the Member States;
  • strongly supports the distinction introduced by the Regulation for low-intervention clinical trials;
  • welcomes the intention to strengthen the safeguards for the processing of personal data as long as there is an appropriate balance between the rights of individuals and the safe and secure use of patient data for health research.

Other EESC opinions:

For more information please contact the INT Section Secretariat