136IN - International research

Date 01 October 2012
Event ESMO Congress 2012
Session ESMO DCTF-AORTIC-SLACOM-UICC-WHO Joint Symposium: Independent and publicly funded research: a new global model
Topics Bioethics, Legal, and Economic Issues
Presenter Tanja Cufer
Authors T. Cufer
  • Medical Oncology Unit, University Clinic Golnik, 4204 - Golnik/SI


Substantial increase in international clinical cancer research (CCR) observed during the last decade is due to fragmentation of major cancer types in biological subtypes with plethora of new treatment agents, both requiring a larger number of CCR participants, as well as to improved infrastructure and skills needed to perform CCR in developing countries. Based on ClinicalTrials.gov registry approx. one third of both academia- and industry-driven CCR is running on international basis nowadays: and the number of countries serving as trial sites in CCR reports published in prestigious journals doubled during the last decade. The scientific and logistical imperative for international CCR is clear, it shortens the time for clinical testing, offers an early access to new treatment strategies worldwide and lowers costs by establishing international networks of CCR. Clinical trials cooperative groups, already established as regional international groups (e.g. NCI-CTG, RTOG, NCIC, EORTC, CECOG, BIG, etc.), offer an excellent platform for exchange of scientific ideas, avoid unnecessary duplication of trials and represent a solid base for expanding international collaboration. But, there are still a lot of regulatory, logistical, financial and scientific issues to be solved to further improve international CCR and maximize its outcome. Regulatory requirements and oversight of the CTs need to be harmonized with data and tissue handling representing one of the main issues. Protection of publication rights and access to trial data is of upmost importance for transparency of CCR in developing countries. The drugs being evaluated in CCR must be available in participating countries, when approved. Formal training programs in CCR and ethics intended to future CCR leaders in developing countries, such as ICTW courses organized by ASCO and other academia organized GCP courses, need to be promoted. Effective collaboration between industry and cooperative groups has to be established. Our ability to establish international collaboration in CCR will results in maximization of our resources and patients, thus permitting international community to further improve cancer control globally through effective CCR.


The author has declared no conflicts of interest.