- 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.
For each study, a designated research team, consisting of a medical team and a healthcare team, is defined. Each team member has the necessary qualifications (education, training and experience) in accordance with the applicable legal requirements. In addition, each team member has the necessary knowledge regarding "Good Clinical Practice" (GCP) and the legal framework within which clinical trials are conducted. In order to further implement and maintain the ISO 9001 quality label, a physician-quality manager has also been appointed within the unit, who is supported by a quality team.
The care team is led by a study coordinator, appointed for a specific study. He/she carries out the administrative activities and manages and processes the data obtained. The coordinator is also responsible for guiding the patient and is in close contact with the sponsor. The study coordinator is assisted by a study nurse who will carry out all study-specific and nursing actions. He/she supports the patient during the course of the study.
As we initiate more and more investigator initiated studies, a project manager became indispensable. He/she coordinates the studies mentioned above, supervises the submission to the GZA Ethics Committee, checks whether all legal requirements are met, supervises the researcher in drawing up the research protocol, etc. ...
In practice, the medical team usually consists of a number of doctors ("subinvestigators (SI)") who are directed and supervised by the principal investigator (PI).
Specialist doctors in hematology, medical oncology and radiotherapy may act as investigators.