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Contains fulltext : 283536.pdf (Publisher’s version ) (Closed access) The Gynecologic Cancer InterGroup (GCIG) sixth Ovarian Cancer Conference on Clinical Research was held virtually in October, 2021, following published consensus guidelines. The goal of the consensus meeting was to achieve harmonisation on the design elements of upcoming trials in ovarian cancer, to select important questions for future study, and to identify unmet needs. All 33 GCIG member groups participated in the development, refinement, and adoption of 20 statements within four topic groups on clinical research in ovarian cancer including first line treatment, recurrent disease, disease subgroups, and future trials. Unanimous consensus was obtained for 14 of 20 statements, with greater than 90% concordance in the remaining six statements. The high acceptance rate following active deliberation among the GCIG groups confirmed that a consensus process could be applied in a virtual setting. Together with detailed categorisation of unmet needs, these consensus statements will promote the harmonisation of international clinical research in ovarian cancer.

Resume Introduction Le Plan Cancer 2014–2019 insiste sur l’importance de la collaboration entre tous les acteurs de la recherche clinique dans la lutte contre le cancer, dont les intergroupes et groupes cooperateurs. Cette enquete avait pour objectif de definir le profil des investigateurs du reseau des Groupes cooperateurs en oncologie et d’identifier certains facteurs qui pouvaient faciliter ou freiner leur activite de recherche clinique. Methodes Un questionnaire a ete envoye a tous les investigateurs ayant participe en 2014 a une etude promue par l’un des 10 membres du reseau des Groupes cooperateurs en oncologie. Il portait sur leur profil, et leur activite de recherche ainsi que sur la structuration de la recherche clinique au sein de leur etablissement. Resultats D’apres les resultats des 366 medecins repondants, les etudes des Groupes cooperateurs en oncologie ont represente une part importante de l’activite de recherche clinique des investigateurs en France en 2014. Ces groupes participent a l’ouverture de centres dans toutes les regions francaises. Une forte activite de recherche clinique des medecins (inclusions de patients > 10) est fortement associee au nombre d’attaches de recherche clinique ou de techniciens d’etudes cliniques (plus de 2 equivalents temps plein (ETP), OR = 11,16 [3,82–32,6] compare a 0 ETP) ainsi qu’a l’exercice de cette activite dans un centre hospitalier universitaire par rapport a un centre hospitalier (OR = 2,15 [1,20–3,83]). Conclusion Cette enquete a permis d’identifier des elements susceptibles de renforcer l’activite de recherche clinique des investigateurs afin de permettre ainsi a un nombre croissant de patients de beneficier de l’innovation therapeutique.

The French Cancer Plan 2014-2019 stresses the importance of strengthening collaboration between all stakeholders involved in the fight against cancer, including cancer cooperative groups and intergroups. This survey aimed to describe the basics characteristics and clinical research activity among the Cancer Cooperative Groups (Groupes coopérateurs en oncologie). The second objective was to identify facilitators and barriers to their research activity.A questionnaire was sent to all the clinicians involved in 2014 as investigators in a clinical trial sponsored by one of the ten members of the Cancer Cooperative Groups network. The questions were related to their profile, research activity and the infrastructure existing within their healthcare center to support clinical research and related compliance activities.In total, 366 investigators responded to our survey. The academic clinical trials sponsored by the Cancer Cooperative Groups represented an important part of the research activity of the investigators in France in 2014. These academic groups contributed to the opening of many research sites throughout all regions in France. Factors associated with a higher participation of investigators (more than 10 patients enrolled in a trial over a year) include the existing support of healthcare professionals (more than 2 clinical research associate (CRA) OR=11.16 [3.82-32.6] compared to none) and the practice of their research activity in a University Hospital Center (CHU) rather than a Hospital Center (CH) (OR=2.15 [1.20-3.83]).This study highlighted factors that can strengthen investigator clinical research activities and subsequently improve patient access to evidence-based new cancer therapies in France.