Educating the next generation of clinical investigators

The Workshop on Methods in Clinical Cancer Research, formerly known as the Flims workshop, was established in 1999 in an attempt to reverse the decline in numbers of clinical cancer researchers. Now in its 20th edition, it has clearly succeeded. Many of today’s top clinical researchers attended Flims, and a recent survey found that participants found the workshop very helpful in their career development and in providing networking opportunities.

In the 90’s, Professor Jean Pierre Armand, from the Institut Gustave Roussy, was invited to participate in a clinical trials workshop organised by AACR in partnership with ASCO in Vail, USA. He brought back the idea of organising the same workshop in Europe, and the FECS-AACR-ASCO workshop on Methods in Clinical Cancer Research was born (later it became ECCO-AACR-EORTC-ESMO workshop). EORTC has been involved in this workshop from its inception in 1999. A number of EORTC staff (medical, statistics) have been faculty, and EORTC fellows have participated as students.

The six-day programme incorporates lectures, small group discussions and one-on-one mentoring sessions all focused on hands-on protocol development. Participants have exclusive access to highly experienced clinical trial researchers, ranging from oncologists to patient advocates, from Europe, the US, and Canada. Additionally, the workshop provides the opportunity to meet and network with a group of 80 junior clinical oncologists from across the world.

EORTC believes that the presence of a strong research base is essential to the future of good quality cancer care. Researchers who have the ability to set up and run high quality clinical trials are vital to the advancement of new therapies. The workshop provides them with the training they need in order to develop and coordinate better clinical and translational trial designs.

When applying to the workshop, participants need to propose a trial protocol and — during the six-day course — to complete writing it, mentored by the experts. The development of the protocol is not a practice run; participants are expected to make every effort to implement it at a later stage. Many important trials with practice-changing results have resulted from this process. EORTC has helped to implement a number of protocols developed at MCCR.  These include EORTC 75111-10114 trial on soft chemotherapy for breast cancer in the elderly and the ongoing EORTC-1559-HNCG – UPSTREAM.

Dr Rachel Galot, an investigator on the EORTC 1559 trial, went to the workshop in 2015. « We had an existing project for a trial in squamous cell carcinoma of the head and neck, looking at how we could make the best therapeutic choices based on the molecular and genetic features of the tumour. It was intended to be a Belgium-only study involving just a few centres.

« Luckily for me, in the faculty were Edward Kim and Ignacio Wistuba, two of the researchers who worked on the Battle trial, one of the first biomarker-based trials in lung cancer, and they shared with me their experiences and the lessons they had learned from their trial. With the input of the group’s statistician, Jan Bogaerts, I totally redesigned the trial. After a week of hard work, it was transformed into an umbrella design with multiple treatment arms that were like separate Phase 2 trials.

« We realised that, because of its size, it was now totally impossible to carry out this trial in a single country, so we presented it to the EORTC head and neck cancer group, and it subsequently became the first international umbrella trial in head and neck cancer.

« The trial commenced recruiting in November 2017 and has currently 40 patients enrolled. We are already working on further modifications in order to add new treatment arms to the design.

« I learned a lot working on this project, not only from a medical point of view, but also about trial design, regulations, and biomarkers. If I had not been to the workshop, I think my professional horizon would have been much more limited! »

Professor Hans Wildiers, from the University Hospital, Leuven, Belgium, and lead investigator on the EORTC 75111-10114 trial says: « In 2011 we were developing the protocol of a trial to look at the effects of trastumuzab and pertuzumab (TP) in elderly patients with HER2 metastatic breast cancer. We were hesitating about whether to do a single arm study (TP alone) or to randomise it with the addition of a TP plus metronomic oral cyclophosphamide (TPM) group. At my suggestion, my PhD student Barbara Brouwers went on the MCCR course at that moment. Feedback from mentors suggested that randomisation would be a better option. And indeed it was!  We achieved a clear, easily interpretable result, which would not have happened if we had gone for TP only.” The data from this trial were presented at the San Antonio Breast Cancer Symposium and published in The Lancet Oncology in 2018.

Applications for this year’s course have now closed. « However, I would strongly advise young clinical researchers to apply in 2019, » says Professor Bertrand Tombal, EORTC president and a Flims student from the first edition in 1999. « This is an exceptional opportunity for improving patient treatment as well as for personal career advancement, and should not be missed. »

20^th ECCO-AACR-EORTC-ESMO Workshop on Methods in Clinical Cancer Research, 16-22 June 2018, Zeist, the Netherlands