Background and Aims
Involving patients in research, not only as trial subjects, is not a newly established practice. Over the last two decades, patient roles have gradually expanded to become active ...research contributors, creating a more patient‐centered research landscape. Our survey has explored the scope of patient involvement within the Gynecologic Cancer InterGroup (GCIG), an International Gynecologic Cancer Research Consortium, and identified challenges in developing a systematic, meaningful and sustainable level of patient involvement.
Methods
In late 2019, the GCIG Harmonisation Operations Committee conducted an online survey across 26 national and/or international research cooperative groups, aiming to identify current patient involvement practices implemented by each group. Twelve questions were asked. The results have been generated to support a systematic strategic planning process to increase patient involvement into clinical research projects.
Results
More than half of the 26 participating groups have either already involved (15, 58%) or are planning (6, 23%) to involve patients in their research activities. Gaining patient support in raising public awareness around clinical trials appears to be one of the most desired benefits (21, 81%). Ten respondents managed to integrate patient involvement into their standard practice. When involving patients in research the groups mostly consider that patients bring added value to the study (19, 73%), although only eight groups (40%) have a well‐organized process in doing so.
Conclusion
Even though patient involvement is considered a significant added value to clinical research, its application within GCIG groups is not considered on a regular basis and is predominantly limited to operational aspects of research activities. The lack of resources and expertize, as well as the missing well‐organized and structured process of some groups, combined with their ability to ensure process sustainability, are among the main factors affecting implementation and adoption of patient involvement within GCIG research activities.
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.
The Gynecologic Cancer InterGroup (GCIG) sixth Ovarian Cancer Conference on Clinical Research (OCCC6) was held virtually in October 2021 following published consensus guidelines. The goal of the ...consensus meeting was to achieve harmonization on design elements of upcoming trials, 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 4 topic groups on clinical research including first line treatment, recurrent disease, disease subgroups and future trials. Unanimous consensus was obtained for 14 of 20 statements, with >90% concordance in the remaining 6 statements. The high acceptance rate following active deliberation amongst 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 harmonisation of international clinical research in ovarian cancer.
The European Network for Gynaecological Oncological Trial groups (ENGOT) is a research network of the European Society of Gynaecological Oncology and was founded in Berlin in October 2007. Earlier, ...we reported on the ENGOT minimal requirements for trials between academic groups and pharmaceutical companies. In this paper, we summarize the roadmap for performing trials in the ENGOT framework. In this roadmap, we define how an ENGOT trial should be set up and discuss the following items: What are the conditions to classify a study as an ENGOT trial? What is an ENGOT protocol? How are an ENGOT protocol, informed consent (ICF), and case report form (CRF) produced? How is the center selection and feasibility performed in ENGOT trials? How are regulatory and operational tasks handled? How should a confidentiality agreement between the industry and the whole ENGOT network be negotiated? How are contracts made between the industry and ENGOT and between ENGOT groups? How are funding, insurance, and communication flow arranged in ENGOT trials? What are the requirements for conducting substudies and what are the tasks for the leading group in an ENGOT trial? A template of a confidentiality agreement, a checklist of ENGOT criteria for new study proposals, and guidelines for authorship are also provided.
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