The Nordic Society of Gynaecologic Oncology -
Clinical Trial Unit (NSGO-CTU)
We are a non-profit organization with the main objective to manage and support clinical research in gynaecologic cancer.
While the organization’s Danish name is, “Nordisk Selskab for Gynækologisk Onkologi’s Kliniske Forskningsfond,” it is commonly referred to as NSGO-CTU and is headquartered at Rigshospitalet in Copenhagen, Denmark.
As a recognized international group and collaborative partner, our daily focus is on developing, initiating, and conducting quality clinical trials within the field of gynaecological oncology to contribute to future advances for patients.
NSGO-CTU is overseen by a Medical Director and two Deputy Medical Directors, who are accountable to the NSGO-CTU Foundation Committee, also known as the NSGO-CTU Foundation Board. The Medical Director is appointed for three-year terms and may be reappointed indefinitely in the best interest of the Foundation and NSGO-CTU.
Dr. Mansoor Raza Mirza has led the clinical trial unit for a decade and is also a Chief Oncologist at Rigshospitalet, Copenhagen University Hospital and Vice-President of ESGO.
Dr. Kristine Madsen (DK) & Prof. Kristina Lindemann (NO) are appointed Deputy Medical Directors to support NSGO-CTU’s Medical Director, Dr. Mirza in managing the Clinical Trial Unit.
NSGO-CTU collectively consists of:
– The Medical Director,
– NSGO-CTU Foundation Committee,
– Two Deputy Medical Directors,
– The staff of the NSGO-CTU Office, and
– The NSGO-CTU Scientific Committee
NSGO-CTU are strong collaborators among professionals in the field of gynaecological cancer. The Clinical Trial Unit conducts educational meetings for colleagues and industry partners.
We organize the Biannual NSGO-CTU Investigator Meeting in Copenhagen and provide updates on the latest developments in cancer research.
NSGO-CTU is affiliated with ENGOT and maintains partnerships with GOG to advance clinical research in the field of gynaecological oncology. In addition to conducting clinical trials in the Nordic countries, our society aims to provide education and training to future Principal Investigators (PIs) and sub-investigators.
Our activities also involve mentoring other groups & organizations and promoting collaboration and camaraderie among experts and organizations worldwide engaged in the field of gynaecological oncology.
The Purpose is to
Clinical trials are an integral component of medical research that assesses the safety, efficacy, and effectiveness of new drugs, medical devices, or treatment modalities. These trials typically involve a complex and multi-faceted process that involves many different stakeholders, including clinicians, researchers, patients, regulatory bodies, and funding agencies. Given the complexity of clinical trials, it is crucial to have effective project management in place to ensure that the research progresses in a timely and efficient manner and that all stakeholders are engaged and informed throughout the process.
As a project management team for clinical trials research, our primary responsibility is to oversee and coordinate all aspects of the research project from start to finish. We work closely with clinical trial investigators to design and develop the trial protocol, define inclusion and exclusion criteria, and identify the appropriate patient population for the study. We also collaborate with regulatory bodies to ensure that the study meets all ethical and regulatory requirements.
One of our critical roles is to oversee the recruitment of patients and ensure that the study is conducted in compliance with Good Clinical Practice (GCP) guidelines. We develop a detailed project plan that outlines the timelines, milestones, and deliverables for the study and ensure that the research team adheres to the plan. We monitor the progress of the study, identify any issues or concerns that arise, and take corrective action as needed to keep the project on track.
Another essential function of our project management team is to facilitate communication and collaboration among all stakeholders. We work closely with study sponsors and funding agencies to ensure that they are updated on the project’s progress and that the study remains aligned with their goals and objectives. We also communicate regularly with the clinical trial investigators and research team to ensure that they are aware of any updates or changes in the study design, protocol, or timelines.
Our responsibility is to ensure that the research project is conducted efficiently, ethically, and in compliance with regulatory guidelines & ensure effective communication and collaboration throughout the project.