ESMO Clinical Research Observatory (ECRO). Improving the effi ciency of clinical research through rationalisation of bureaucracy

Jose Luis Perez-Gracia (1), Ahmad Awada (2), Emiliano Calvo (3), Teresa Amaral (4), Hendrik-Tobias Arkenau (5), Viktor Gruenwald (6), Gyorgy Bodoky (7), Martijn P Lolkema (8), Massimo Di Nicola (9), Nicolas Penel (10), Ruth Vera (11), Miguel F Sanmamed (1), Jean-Yves Douillard (12)
(1) Department of Oncology, University Clinic of Navarra and Health Research Institute of Navarra (IdiSNA), Pamplona, Spain
(2) Department of Oncology Medicine, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium
(3) START Madrid-CIOCC, Centro Integral Oncológico Clara Campal, Hospital Universitario HM Sanchinarro, Madrid, Spain
(4) Interdisciplinary Skin Cancer Center, University Medical Center, Tuebingen, Germany
(5) Sarah Cannon Research Institute and University College, London, United Kingdom
(6) Interdisciplinary Genitourinary Oncology at the West-German Center, Clinic for Internal Medicine (Tumor Research) and Clinic for Urology, University Hospital Essen, Essen, Germany
(7) Department of Oncology, St László Teaching Hospital, Budapest, Hungary
(8) Department of Medical Oncology, Erasmus Medical Center Cancer Center. Erasmus Medical Center, Rotterdam, The Netherlands (9) Immunotherapy and Innovative Therapeutic Unit, Department of Medical Oncology and Hematology, Fondazione IRCCS Istituto
Nazionale dei Tumori, Milan, Italy
(10) Department of Medical Oncology, Centre Oscar Lambret and Lille University, Lille, France
(11) Department of Medical Oncology, Complejo Hospitalario de Navarra and Navarra Institute for Health Research (IdiSNA), Pamplona, Spain
(12) Scientific and Medical Division, European Society for Medical Oncology (ESMO), Lugano, Switzerland

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.

„The only thing that saves us from bureaucracy is its inefficiency.”
Eugene McCarty (1916–2005)

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