Douillard, J.Y. (J. Y.)

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2018 - 20202

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    Starting the fight in the tumor: expert recommendations for the development of human intratumoral immunotherapy (HIT-IT)
    (Elsevier, 2018) Tersago, D. (Dominique); Massacesi, C. (C.); Klumper, E. (E.); Robert, C. (C.); Rahimian, S. (S.); Kumar, R. (R.); Hendriks, M. (M.); Tabernero, J. (J.); Douillard, J.Y. (J. Y.); Andtbacka, R. (R.); Leidner, R. (R.); Baurain, J.F. (J. F.); Haanen, J. (J.); Marabelle, A. (Aurelien); Stern, M. (M.); Harrington, K. (K.); Brody, J. (J.); Baere, T. (T.) de; Melero, I. (Ignacio); Tse, A. (A.); Imperiale, M. (M.); Tchakov, I. (I.); Ascierto, P.A. (Paolo Antonio); Öhrling, K. (K.)
    A European Society for Medical Oncology (ESMO)-sponsored expert meeting was held in Paris on 8 March 2018 which comprised 11 experts from academia, 11 experts from the pharmaceutical industry and 2 clinicians who were representatives of ESMO. The focus of the meeting was exclusively on the intratumoral injection/delivery of immunostimulatory agents with the aim of harmonizing the standard terms and methodologies used in the reporting of human intratumoral immunotherapy (HIT-IT) clinical trials to ensure quality assurance and avoid a blurring of the data reported from different studies. The goal was to provide a reference document, endorsed by the panel members that could provide guidance to clinical investigators, pharmaceutical companies, ethics committees, independent review boards, patient advocates and the regulatory authorities and promote an increase in the number and quality of HIT-IT clinical trials in the future. Particular emphasis was placed not only on the development of precise definitions to facilitate a better understanding between investigators but also on the importance of systematic serial biopsies as a driver for translational research and the need for the recording and reporting of data, to facilitate a better understanding of the key processes involved.
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    ESMO clinical research observatory (ECRO): improving the efficiency of clinical research through rationalisation of bureaucracy
    (Elsevier, 2020) Arkenau, H.T. (Hendrik-Tobias); Lolkema, M. (Martijn); Perez-Gracia, J.L. (Jose Luis); Douillard, J.Y. (J. Y.); Calvo, E. (Emiliano); Amara, T. (Teresa); Gruenwald, V. (Viktor); Bodoky, G. (Gyorgy); Awada, A. (Ahmad); Di-Nicola, M. (Massimo); Fernandez-Sanmamed, M. (Miguel); Penel, N. (Nicolas); Vera, R. (Ruth)
    During the last years, there has been a dramatic increase in the administrative and bureaucratic burden associated with clinical research, which has clearly had an impact on its overall efficiency and on the activity of clinical investigators and research teams. Indeed, the supervision of the adherence of clinical research to Good Clinical Practice (GCP) guidelines and legal regulations is of the utmost importance. Yet, while such regulations have remained largely unchanged during recent years, the number of administrative tasks and their complexity have grown markedly, as supported by the results of a survey performed among 940 clinical investigators that we report in this manuscript. Therefore, many investigators believe that it has become necessary to undertake a rigorous analysis of the causes and consequences of this issue, and to create a conduit to channel the advice from experienced investigators regarding clinical research procedures, in order to improve them. Based on these premises, ESMO has launched the ESMO Clinical Research Observatory (ECRO), a task force that will analyse different aspects of clinical research. ECRO will aim to provide the views of ESMO on clinical research procedures based on the feedback from clinical investigators, under complete adherence to the Declaration of Helsinki, the GCP guidelines and any other applicable legal regulations, while at the same time showing profound respect for all the stakeholders involved in clinical research. This manuscript provides the background and rationale for the creation of ECRO, its planned activity and an analysis of the current administrative burden in clinical research with recommendations to rationalise it. Indeed, we expect that this effort shall lead to a relevant improvement in the care of patients and in the development of clinical research