Oncologie (Kanker - Gezwelziekten): Who are we?

• CTO strives to make an active scientific contribution to the progress of cancer treatments by participating in clinical trials in an efficient manner. Efficiency implies working in a correct, punctual, orderly, comprehensive and structured manner. 
• CTO uses well-defined procedures and the best possible technical resources for its organisation and implementation. Financial constraints are taken into account.
• CTO aims to produce objective, reliable and correct data within the required timelines. When producing these data, CTO explicitly works in a patient-oriented way within the boundaries imposed by the study protocol with special attention to patient safety. In the context of patient safety, a dedicated on-call system is active.
• CTO strives for optimal collaboration with both internal and external sponsors and attempts, to fulfill the needs of the sponsor, the patient and its employees.
• CTO respects professional secrecy, the confidentiality of study reports and patient privacy.
• CTO is committed to communicating optimally with external parties: the sponsor, patients and doctors. Internally, too, CTO wants to use dialogue as an important form of communication.
• CTO wants to be competitive, both nationally and internationally, supported by a high degree of professionalism.
• CTO considers quality to be of paramount importance and is therefore putting the necessary monitoring and adjustment systems in place. These quality systems are designed in accordance with existing legislation and in conformity with the GCP guidelines.
• CTO guarantees the ongoing training of doctors and staff at the Oncology Centre.

In 1996, at the instigation of Dr Luc Dirix, the Oncology Centre of GZA Ziekenhuizen, Sint-Augustinus campus, started participating in phase II and phase III studies in breast cancer. From 1999 onwards, participation in phase I studies was also initiated.

As the number of studies and the study areas were expanded to include medical oncology, radiotherapy and hematology, restructuring was required. Thus, in 2010, Clinical Trials Oncology (CTO) was founded.

At the beginning of 2011, CTO was incorporated as a unit into the Oncology Research Department of the Oncology Centre, together with the Translational Cancer Research Unit (TCRU). In recent years, the unit has been working on improving quality, safety of its patients and reliability of its results. As a result, it holds an ISO 9001 quality label since 18 April 2013.

In 2021 a name change was introduced: Clinical Trials Oncology became Clinical Trials Office (CTO).

CTO defines its activities as a process by which clinical studies (phase I, II, III, IV) are planned, conducted, monitored, recorded, reported and archived at external or internal request and after written approval by the Scientific Policy Committee and the Review Chamber of the Medical Ethics Committee of GZA.

In doing so, the data is generated, documented and reported in accordance with the ICH Topic E6: guideline for Good Clinical Practice (GCP), the legislation and the imposed study protocol.

External sponsors are:

• Commercial organisations;
• Non-commercial organisations or Clinical Research Organisations (CROs) acting on behalf of a commercial organisation.

Internal sponsors are:

• Specialist doctors from the Oncology Centre

They often design and initiate studies, which we call investigator initiated studies.