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      ESMO Clinical Research Observatory (ECRO): improving the efficiency of clinical research through rationalisation of bureaucracy

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          Abstract

          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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          Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement

          Purpose The primary purposes of eligibility criteria are to protect the safety of trial participants and define the trial population. Excessive or overly restrictive eligibility criteria can slow trial accrual, jeopardize the generalizability of results, and limit understanding of the intervention’s benefit-risk profile. Methods ASCO, Friends of Cancer Research, and the US Food and Drug Administration examined specific eligibility criteria (ie, brain metastases, minimum age, HIV infection, and organ dysfunction and prior and concurrent malignancies) to determine whether to modify definitions to extend trials to a broader population. Working groups developed consensus recommendations based on review of evidence, consideration of the patient population, and consultation with the research community. Results Patients with treated or clinically stable brain metastases should be routinely included in trials and only excluded if there is compelling rationale. In initial dose-finding trials, pediatric-specific cohorts should be included based on strong scientific rationale for benefit. Later phase trials in diseases that span adult and pediatric populations should include patients older than age 12 years. HIV-infected patients who are healthy and have low risk of AIDS-related outcomes should be included absent specific rationale for exclusion. Renal function criteria should enable liberal creatinine clearance, unless the investigational agent involves renal excretion. Patients with prior or concurrent malignancies should be included, especially when the risk of the malignancy interfering with either safety or efficacy endpoints is very low. Conclusion To maximize generalizability of results, trial enrollment criteria should strive for inclusiveness. Rationale for excluding patients should be clearly articulated and reflect expected toxicities associated with the therapy under investigation.
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            Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015

            Clinical trial eligibility criteria are necessary to define the patient population under study and improve trial safety. However, there are concerns that eligibility criteria for cancer clinical trials are too restrictive and limit patient enrollment in clinical trials. Recently, there have been initiatives to re-examine and modernize eligibility criteria for oncology clinical trials. To assess current eligibility requirements for cancer clinical trials, we have conducted a comprehensive review of eligibility criteria for commercial investigational new drug clinical trial applications submitted to the US Food and Drug Administration Office of Hematology and Oncology Products in 2015. Our findings suggest that eligibility criteria for current cancer clinical trials tend to narrowly define the study population and limit the study to lower-risk patients, which may not be reflective of the greater patient population outside of the study. We discuss potential areas for expanding eligibility criteria to include more patients in clinical trials and design options for clinical trials incorporating expanded eligibility criteria. The broadening of clinical trial eligibility criteria can be considered to better reflect the real-world patient population, improve clinical trial participation, and increase patient access to new investigational treatments.
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              Modernizing Clinical Trial Eligibility: Recommendations of the American Society of Clinical Oncology–Friends of Cancer Research Minimum Age Working Group

              Purpose Children have historically been excluded from first-in-human studies of promising new cancer drugs and later phase adult clinical trials. Delays in evaluation may result in off-label use without dosing information as the only access to new drugs. A multistakeholder workshop was convened in May 2016 by ASCO and Friends of Cancer Research to identify opportunities for when it would be scientifically appropriate to expand trial eligibility to include children younger than age 18 years in first-in-human and other adult cancer clinical trials. Methods This group convened experts from academia, government, and industry to review barriers to enrolling children and adolescents in oncology clinical trials. We evaluated the historical context, published literature, regulatory considerations, and myriad risks and benefits associated with lowering the age of enrollment on oncology clinical trials. Results We conclude that many of the historical concerns about including children early in oncology clinical trials do not apply in the current scientific and clinical environment of pediatric oncology and drug development; we provide specific recommendations for how the inclusion of children in early-phase investigational cancer drug trials might be accomplished. Automatic inclusion of pediatric patients is appropriate in early-phase trials that assess dose, safety, and pharmacokinetics in a variety of tumor types and later phase trials that assess efficacy in a specific disease that spans adult and pediatric populations. Conclusion Including children in appropriately designed adult clinical oncology trials is feasible and can be done in a way that enhances their access to these agents without compromising safety or development strategies.
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                Author and article information

                Journal
                ESMO Open
                ESMO Open
                esmoopen
                esmoopen
                ESMO Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2059-7029
                2020
                10 May 2020
                : 5
                : 3
                : e000662
                Affiliations
                [1 ]departmentDepartment of Oncology , University Clinic of Navarra and Health Research Institute of Navarra (IdiSNA) , Pamplona, Spain
                [2 ]departmentDepartment of Oncology Medicine , Institut Jules Bordet, Université Libre de Bruxelles , Brussels, Belgium
                [3 ]departmentSTART Madrid-CIOCC , Centro Integral Oncológico Clara Campal, Hospital Universitario HM Sanchinarro , Madrid, Spain
                [4 ]departmentInterdisciplinary Skin Cancer Center , University Medical Center , Tuebingen, Germany
                [5 ]Sarah Cannon Research Institute and University College , London, United Kingdom
                [6 ]departmentInterdisciplinary Genitourinary Oncology at the West-German Cancer Center, Clinic for Internal Medicine (Tumor Research) and Clinic for Urology , University Hospital Essen , Essen, Germany
                [7 ]departmentDepartment of Oncology , St László Teaching Hospital , Budapest, Hungary
                [8 ]departmentDepartment of Medical Oncology , Erasmus Medical Center Cancer Center. Erasmus Medical Center , Rotterdam, The Netherlands
                [9 ]departmentImmunotherapy and Innovative Therapeutic Unit, Department of Medical Oncology and Hematology , Fondazione IRCCS Istituto Nazionale dei Tumori , Milan, Italy
                [10 ]departmentDepartment of Medical Oncology , Centre Oscar Lambret and Lille University , Lille, France
                [11 ]departmentDepartment of Medical Oncology , Complejo Hospitalario de Navarra and Navarra Institute for Health Research (IdiSNA) , Pamplona, Spain
                [12 ]departmentScientific and Medical Division , European Society for Medical Oncology (ESMO) , Lugano, Switzerland
                Author notes
                [Correspondence to ] Dr Jose Luis Perez-Gracia; jlgracia@ 123456unav.es
                Author information
                http://orcid.org/0000-0003-4941-9075
                http://orcid.org/0000-0002-2516-5181
                Article
                esmoopen-2019-000662
                10.1136/esmoopen-2019-000662
                7223268
                32393574
                f48e8fd2-2222-4e37-ba05-684fcf97b5d9
                © Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, any changes made are indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 13 December 2019
                : 03 March 2020
                : 04 March 2020
                Categories
                Review
                1506
                Custom metadata
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                clinical research,bureaucracy,administrative burden,clinical interference,pharmacovigilance

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