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.
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Competing interests JLP-G: Research grants and support: Roche, BMS, MSD, Ipsen, Eisai, Incyte, Janssen. Speakers bureau and advisory boards: Roche, BMS, Ipsen, Eisai, MSD, Seattle Genetics. Travel support: Roche, MSD, BMS. AA: Advisory role, research grants to my Institute. Speaker fees: Roche, Lilly, Amgen, EISAI, BMS, Pfizer, Novartis, MSD, Genomic Health, Ipsen, AstraZeneca, Bayer, Leo Pharma. EC: Honoraria or consultation fees: Astellas, Novartis, Nanobiotix, Pfizer, Janssen-Cilag, GLG, PsiOxus Therapeutics, Merck, Medscape, BMS, Gilead, Seattle Genetics, Pierre Fabre, Boehringer Ingelheim, Cerulean Pharma, EUSA, Gehrmann Consulting, AstraZeneca, Roche, Guidepoint, Servier, Celgene, Abbvie, Amcure, OncoDNA, Alkermes. Leadership role: Director, Clinical Research, START Madrid, Director, Clinical Research, HM Hospitals Group, Madrid. Stocks or ownership: START, Oncoart Associated, International Cancer Consultants. Licensing fees or royalties: None. Direct research funding as project lead: Novartis, AstraZeneca, Beigene. Institutional financial support from clinical trials: Abbvie, ACEO, Amcure, AMGEN, AstraZeneca, BMS, Cytomx, GSK, Genentech/Roche, H3, Incyte, Janssen, Kura. Lilly, Loxo, Nektar, Macrogenics, Menarini, Merck, Merus, Nanobiotix, Novartis, Pfizer, PharmaMar, Principia, PUMA, Sanofi, Taiho, Tesaro, BeiGene, Transgene, Takeda, Incyte, Innovio, MSD, PsiOxus, Seattle Genetics, Mersana, GSK, Daiichi, Nektar, Astellas, ORCA, Boston Therapeutics, Dynavax, DebioPharm, Boehringen Ingelheim, Regeneron, Millenium, Synthon, Spectrum, Rigontec. Non-financial interests: Scientific board at PsiOxus. Leadership in medical society: Founder and president, non-for-profit Foundation INTHEOS (Investigational Therapeutics in Oncological Sciences). Memberships: SEOM, EORTC, ESMO, ASCO. Other relationships: HM Hospitals Group and START, Program of Early Phase Clinical Drug Development in Oncology, Employee: Medical Oncologist, Director, Clinical Research. Methods in Clinical Cancer Research (MCCR) Workshop, Zeist, Netherlands (Joint ECCO-AACR-EORTC-ESMO Workshop on Methods in Clinical Cancer, Research), Co-director. TA: travel grants from Novartis, personal fees and travel grants from BMS, personal fees from Pierre Fabre and research grant from Neracare, outside the submitted work. H-TA: Research Support to Employer: Employee of HCA Healthcare UK and Sarah Cannon Research Institute. Advisory Boards: Roche, Servier, Merck Serono, Biontech, Bicycle, Taiho, Beigene, Iovance, Bayer, Guardant. VG: honoraria for lectures and advisory role: AstraZeneca, Bayer, BMS, EUSAPharm, Ipsen, Pfizer, MSD, Lilly, PharmaMar. Novartis, Nanobiotix, MerckSerono, Janssen-Cliag, Exelexis, Roche, Eisai, Cerulean. Research funding: AstraZeneca, BMS, Novartis, MSD, Pfizer. GB: Advisory board and speakers bureau: Pfizer, Novartis Roche Servier Janssen Ipsen Lilly Amgen Merck. Travel support: Pfizer Janssen Roche MSD. MPL: Research grants (to hospital) MSD/Astellas/JnJ/ Sanofi. Advice: Roche/ Bayer/Amgen/JnJ/ Sanofi/ Servier/Pfizer/ Incyte. MDN: Speakers bureau and advisory boards: BMS. Travel support: MSD, BMS. NP: Research grants and support: Bayer HealthCare, Roche, Sanofi. Speakers bureau and advisory boards: Astellas, Bayer HealtCare, Ipsen, Janssen Roche, Genetics. Travel support: Ipsen, Pharmamar. MFS: Research grants: Roche. RV: Speakers bureau and advisory boards: Roche, BMS, MERK, AMGEN, SANOFI, MSD, BAYER, SERVIER. Travel support: Roche, MSD, AMGEN, MERK, SANOFI, BAYER. J-YD: No conflict of interest to disclose.
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