The Cooperator Groups in Oncology (CGO): who are they?

In a previous blog post that you can read here, Vanessa Montanari had presented Patients Committee for Clinical Research (PCCR) in French: « Comité de Patients pour la Recherche Clinique (CPRC) ». On June 22nd, I went to one of the plenary sessions of the League against Cancer, in order to know more about the CGO with which the PCCR is partner.

We will tell you in this article what we have learned from this entity which is not always known by clinical research associate.

1. Oncology Cooperator group: Who are they?

The CGO for Cooperator Groups in Oncology gathers academic research groups. They are independent, nonprofit, and are specialized in oncology (see list of members below). Their objective is to improve the survival and quality of life for patients with cancer.

The founding members of this association are:
– ARCAGY-GINECO =Research Association on cancers including gynecological – National Investigators Group for the Study of Ovarian and Breast Cancer. In French (Association de Recherche sur les CAncers dont GYnécologiques – Groupe d’Investigateurs Nationaux pour l’Étude des Cancers Ovariens et du sein)
– FFCD =French Federation of Digestive Oncology. In French (Fédération Francophone de Cancérologie Digestive)
– GERCOR = Multidisciplinary Cooperator Group in Oncology. In French (Groupe Coopérateur Multidisciplinaire en Oncologie)
– GORTEC =Radiotherapy Oncology Group of Head And Neck. In French (Groupe Oncologie Radiothérapie de la Tête Et du Cou)
– IFCT = Francophone Intergroup of Thoracic Oncology. In French (Intergroupe Francophone de Cancérologie Thoracique)
– MFI = Francophone Intergroup of Myeloma. In French (Intergroupe Francophone du Myélome)
– LYSA = LYmphoma Study Association
– LYSARC = LYmphoma Academic Research Organisation

And their associate groups are :
– SFCE =French Society of fight against Child and Adolescent cancers and leukemia (Société Française de lutte contre les Cancers et les leucémies de l’Enfant et de l’adolescent)
– IGCNO/ANOCEF = Intergroup Cooperator in Neurology and Oncology (Intergroupe Coopérateur en Neuro-Oncologie)

Thanks to their expertise areas extending from solid tumors to liquid tumors, CGO became one of the major player in clinical research. Especially since their role is enhanced by:

• Their own operational structure (project managers, CRAs, biostatisticians, data managers…) enabling them to design and conduct clinical studies of phases I to III, both in France and in the international scale, and to communicate results (transparency in clinical research: the results are published, no matter the outcome of the study);
• Their unique ability to recruit patients through their network organization for many years at national and European level (more than 400 health facilities);
• Their collaborations with public institutions (INSERM, CNRS …)
• The research partnerships with the industry;
• The results publication  of their studies on well-known medical newspapers;
• Their certification by the Inca since 2012 (= National Cancer Institute).

2. What types of studies do the CGO realize?

Clinical studies of CGO focus on marketed drugs or non marketed drugs. For marketed drugs, they are not necessarily used in the indication referred to their marketing authorization (= Authorization Market) in French : AMM (= Autorisation de Mise sur le Marché).

Besides drugs, CGO studies may focus on finding new biomarkers or validation of known biomarker, on the diagnostic or prognostic tools validation, on epidemiological, pharmaco-economics, quality of life aspects…their goal is to answer to questions that often investigators arise, while improving patients quality of life.

Therefore, CGO carry out academic clinical research, but sometimes, it is necessary for CGO to work with the pharmaceutical industry to answer questions; especially when the study focuses on a molecule that is not having a marketing authorization (AMM). In this case, a partnership agreement between the CGO and industry is signed. These partnership agreements are governed by the principles of the CGO / industry charter that fix, notably, the responsibilities of one another.

3. CGO / industry charter: what does it say?

Through this charter, the CGO guarantees Clinical Research Independence in:

• Designing independently, trials answering a scientific question
• Charging the study protocol writing to an independent committee of the industrial promoter and CGO (industrial promoter may give opinions but only CGO are responsible for the final version of the protocol)
• Proofreading the statistical part by CGO statisticians
• Designating the principal study investigator and the study Steering Committee members (the CGO therefore choose the centers able to participate in the study)
• Ensuring the study promotion as often as possible (not the industry where it is possible)
• Signing a contract with industrial partners
• Ensuring that no conflict of interest exists between the members of the IDMC (Independent Data Monitoring Committee whose members are appointed by the Promoter) and the industrial partner.

As the promoter, it provides on-site monitoring and data management as requested by current regulations.

Once the study is completed, the CGO publish the results, whether positive or negative by including, of course, the industrial partners involved.

With several thousands of patients each year included in their clinical trials through their networks, the CGO became one of the major French actors of clinical research in oncology. Their work regularly allow the introduction of new drugs or new therapeutic strategies and thus improve the effectiveness, tolerance and / or the cost of cancer treatment, promoting better care for patients.

For more information on CGO, you can go on their website: http://www.gco-cancer.org/.

Sources:

• Slideshow presentation Cécile Girault, FFCD member, CGO
• CGO website http://www.gco-cancer.org/

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