Clinical Research

Maastro Clinical Research

Clinical Research provides opportunities for Maastro to improve care and treatment for patients in order to maximise the effect of the treatment while minimising physical and mental side effects. This is accomplished partly by participating in studies set up by other hospitals that requires implementation of state of the art radiotherapy.

Maastro initiates clinical research, by itself or in cooperation with partners, to develop new innovations in treatment. A key aspect of these studies is the implementation of innovations in clinical practice. In accordance with the Maastro strategy, the topic of future clinical research lies preferably in the field of proton-therapy, immunotherapy and shared decision making.

Maastro supports clinical trials with the clinical research office Data Centre Maastro (DCM). DCM provides support for all clinical research within the organisation and supports all stages of clinical research – from protocol development and submission for ethics approval to analysing the data and writing a manuscript. An important part of DCM is the Trial Outpatient Clinic: hands on support to patients and researchers through the whole process of participation in a clinical study.

Clinical Trial Organisation

Clinical Research Office

The Data Centre Maastro (DCM) is the clinical research office responsible for the administrative and logistical support of clinical research within Maastro clinic. DCM also coordinates scientific projects for external parties as a contract research organisation. All clinical research is conducted according to the standards set by relevant guidelines, such as Good Clinical Practice (GCP Directive 2005/28/EC). All DCM-employees are certified with respect to GCP.

We can provide support for a number of activities, such as:

Writing a grant proposal or research protocol
Obtaining research agreements and quotes for research activities
Designing and building a research database (e.g. in OpenClinica)
Local approval for participating centres
Medical Ethics approval (including central review by CCMO)
Completing EudraCT procedures
Completing and maintaining clinical trial registries (e.g. clinicaltrials.gov)
Setting up study logistics
Screening potential participants for eligibility
Informed consent procedure
Registration and randomisation of participants (including the design of the randomisation procedure)
Gathering and entering study data
Adverse event management (including SAE and SUSAR)
Archiving, querying and reporting
Data cleaning
Statistical analyses
Support for writing scientific reports and manuscripts

The Data Centre Maastro (DCM) works together with partners such as the Maastricht University Medical Centre (MUMC+), the Clinical Trial Center Maastricht (CTCM) and the European Biobank Maastricht.

Trial Outpatient Clinic

The Trial Clinic is an integral part of the Data Centre Maastro (DCM) and is aimed at guiding patients through the whole process of participating in clinical research.

The Trial Clinic consists of dedicated physician assistants and trial assistants. They identify which patients might be eligible for participation in a specific clinical trial and provide the patient with information about the study in order to obtain informed consent.

Throughout the study, the Trial Clinic accompanies the patient during study activities and carries out study measurements. Accurate results of clinical research are only possible when the data gathered are relevant and complete.

IRB

Institutional Review Board (IRB)

The Institutional Review Board (IRB) is tasked with advising on the scientific quality and the feasibility of clinical research projects in Maastro.

The IRB provides advice to the Board of Directors on the local practicality of execution of a clinical trial, both from the viewpoint of Maastro and from the viewpoint of the patient participating in the trial. Furthermore, the IRB registers and approves re-use of patient data gathered in clinical practise for the purpose of retrospective research.

IRB meetings are planned 4 times per month and both researchers, clinical staff and trial support staff take part in the meetings.