2 September 2024

International project management: creativity according to plan

The effort involved in prospective clinical trials with international participation should not be underestimated. Professional project management substantially helps to run international study centres efficiently and to conduct research across national borders successfully.

A clinical researcher who has years of experience in conducting international studies in an academic setting is Prof. Walter Weber, Head of Department Breast, Abdomen and Pelvis, Head of Breast Surgery and Site Director of the Basel Breast Center at the University Hospital Basel. He relies on small, well-coordinated teams with clearly defined responsibilities and the opportunity to deputise for one another. "Larger teams are not necessarily stronger," says Walter Weber, as there are more interfaces where information can get lost.

Communication is the key to success when conducting such a complex project as an international, randomised, multicentre study. Weekly meetings are standard. They are crucial for keeping everyone involved informed and motivated.

Collaborations with DKF Scientific Services

Walter Weber appreciates having a central contact person for all matters relating to his studies. He is referring to Alexandra Schulz, Team Leader Project Management at the DKF. She heads up communication with the study centres in close consultation with him and his team and coordinates the collaboration of all project partners, including other DKF Scientific Services.

For Alexandra Schulz, good communication is also crucial for successful project management on an international level, which is fundamentally complex, due to the multilingualism and the different legal requirements and activities such as feasibility analyses, securing funding, contract negotiations, reporting, ongoing motivation of the study centres and ensuring data quality take place.

As a central coordination office, she links the respective expertise and interests of all stakeholders. This requires good planning and organisational skills in order to maintain an overview, but also an eye for detail and the ability to empathise with others. The focus is on the common goal. To achieve this, it is also important to find creative solutions to ever new challenges.

Coordinating several centres

In addition to the two large randomised studies TAXIS and PREPEC of the Oncoplastic Breast Consortium (OPBC)*, which was founded by Walter Weber around 7 years ago, the DKF Scientific Services support 10 additional large prospective, mostly clinical studies with international participation in project management (see box). In total, 281 study centres are supported. Three quarters of these are located abroad.

* Latest publications of the OPBC

• OPBC-05 ICARO: Nodal burden and nodal recurrence in patients with isolated tumor cells after neoadjuvant chemotherapy treated with axillary dissection or axillary radiation
  Accepted for publication in JCO, July 2024
• OPBC-04 OMA: Omission of Axillary Dissection Following Nodal Downstaging With Neoadjuvant Chemotherapy
• OPBC-03 TAXIS: Association of Axillary Dissection With Systemic Therapy in Patients With Clinically Node-Positive Breast Cancer
• OPBC-03 TAXIS (SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101): Impact of Imaging-Guided Localization on Performance of Tailored Axillary Surgery in Patients with Clinically Node-Positive Breast Cancer
• OPBC-03 TAXIS (SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101): Trends in use of neoadjuvant systemic therapy in patients with clinically node-positive breast cancer
• OPBC Delphi and Consensus 2023: Uncertainties and controversies in axillary management of patients with breast cancer