What is ENGOT? Antonio González Martín Clínica Universidad de Navarra, Madrid GEICO (Grupo Español de Investigación en Cáncer de Ovario) ENGOT (European Network of Gynecological Oncological Trials groups) Many thanks for your kind invitation….

Who we are The European Network for Gynaecological Oncological Trial groups (ENGOT) is a research network of the European Society of Gynaecological Oncology (ESGO) and was founded in Berlin in October 2007.

Who we are ENGOT is a network of national and regional cooperative groups, ENGOT coordinates and promotes clinical trials within Europe on patients with gynaecological cancer. This coordination is particularly relevant for academic clinical trials, translational research, research on rare diseases, and for clinical trials sponsored by the industry to perform multinational studies in Europe. ENGOT consists of 20 groups from 25 countries.

ENGOT mission and vision ENGOT is a platform that guarantees that the European spirit and culture is incorporated into the medical progress in gynaecological oncology, and that all European patients and countries can participate in an active way in clinical research and progress. The ultimate goal is to bring the best treatment to gynecological cancer patients through the best science, and enabling every patient in every European country to access a clinical trial.

ENGOT structure Co-chairs (Clinical and Operational) elected every 2 years Strategic group created Representatives of 9 biggest groups, admin chair, GCA chair, ESGO council representative Teleconferences when necessary ESGO Council representative at ENGOT: Mansoor Mirza ENGOT-GOG Liason ENGOT chair, past chair, elected chair participating as ENGOT, plus Ignace Regular teleconferences and meetings

ENGOT is a patient oriented organization Rare tumours Early phase I/II disease oriented Practice changing phase III designs Patient Reported Outcomes Unmet medical needs Patients

ENGOT active iniciatives Translational (Biobank) Rare tumors Phase I/II GCA

ENGOT achievements Assembly of almost all European national groups -> 20 members -> new since 2013: ISGO Israel, SAKK Switzerland, CEEGOG (Central & East European GOG), PGOG Poland 69 trials so far (ovarian, endometrial, cervical and vulvar) 11 scientific publications so far, some of them are practice changing Sessions at ESGO and ESMO congresses

ENGOT achievements

Data base property One protocol developed and agreed upon by the lead study group and the industry partner, reviewed, and approved by the trial steering committee. Both the industry partner and the lead study group will agree on 1 common statistical analysis plan (SAP) or produce their own SAPs. In case of 2 different SAPs, the leading study group’s SAP will be the basis for all academic publications. One database agreed on by the lead study group and the industry partner.

Data base according to model Option A: the database itself at the lead study group Option B: the database at the CRO; the CRO is contracted by the lead study group. Option C: database at the CRO or company. The choice of a CRO is made in mutual agreement between the lead group and the industry. Every transfer of the database for analysis must be agreed on by the leading group.

ENGOT partnership with industry Strengths Design of clinical trials Patient oriented Focus on unmet medical needs Academic participation and “validation” of clinical trials design is a plus for credibility Clinically-oriented translational research designs (Translational Research Group) Opportunity of helping in the development of the pipeline from the beginning (from Phase I/II Group to phase III design)

Model of ENGOT leaded selection ENGOT as a framework for launching several trials in the same indication in a wise way The case of fron-line trials STUDY A STUDY B STUDY C Site1 Site1 Site1 Site1 Site1 Site1 Model of ENGOT leaded selection Site2 Site2 Site2 Site2 Site2 Site2 CRO delegation process Site3 Site3 Site3 Site3 Site3 Site3 Site4 Site4 Site4 Site4 Site4 Site4

Take home message The ultimate goal is to bring the best treatment to gynecological cancer patients through the best science, and enabling every patient in every European country to access a clinical trial. Partnership with ENGOT can lead to a wise development of strategies and pipelines of different companies by supporting all in a fair manner

https://engot.esgo.org/