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Many clinical trials are typically performed in large radiation oncology departments. Investigators from both your own hospital and other hospitals can initiate these trials. Every clinical trial is different and including a patient into a clinical trial can be quite labour intensive. Starting with the administrative work for the inclusion, but also the follow up assessments of patients according to the study protocol, takes much time. In our department, this used to be the responsibility of the radiation oncologist treating the patient. As this increased their workload, it resulted in fewer inclusions than desired by the department and missing data due to non-standard follow up. Depending on the trial, extra imaging, questionnaires or follow-up appointments with the radiation oncologist can be required. If this deviates from the standard care, it could easily be overlooked and forgotten.

A support system can be created to support the radiation oncologists in all the work required for a clinical trial and to aid in patient compliance. There are multiple options for a support system, for example research nurses, nurse practitioners and radiation technologists (RTTs). RTTs already have extensive knowledge of the processes regarding the treatment of the patients and see patients on a daily basis. RTTs can then also be a contact person for further questions patients may have concerning the trial.

Therefore, in our department a study support group was set up consisting of RTTs. By starting the study support group, the department aimed to increase the inclusions in clinical trials, patient compliance and to structure the follow up of patients included in a clinical trial.

At this moment, the group consists of four RTTs working part time for the study support group and the rest of their time on the Linacs. A trial coordinator keeps oversight of all the clinical trial related work, which includes Local and Central Datamanagement, Clinical Project Management, Statistics and the activities of the study support group.

The activities of the study support group vary per clinical trial. In general, the RTTs handle the Informed Consent Forms, send out, receive and process the study questionnaires and keep oversight of all study assessments per protocol. The study support group is the central contact point for all questions regarding the execution of a radiotherapy clinical trial for patients as well as radiation oncologists and other colleagues.

In the presentation, an overview will be given of the support provided by the RTTs for various clinical trials.