15 results on '"Position paper"'
Search Results
2. COVID‐19 pandemic: Practical considerations on the organization of an allergy clinic—An EAACI/ARIA Position Paper.
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Pfaar, Oliver, Klimek, Ludger, Jutel, Marek, Akdis, Cezmi A., Bousquet, Jean, Breiteneder, Heimo, Chinthrajah, Sharon, Diamant, Zuzana, Eiwegger, Thomas, Fokkens, Wytske J., Fritsch, Hans‐Walter, Nadeau, Kari C., O'Hehir, Robyn E., O'Mahony, Liam, Rief, Winfried, Sampath, Vanitha, Schedlowski, Manfred, Torres, María José, Traidl‐Hoffmann, Claudia, and Wang, De Yun
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COVID-19 pandemic , *COVID-19 , *MEDICAL personnel , *SARS-CoV-2 - Abstract
Background: The coronavirus disease 2019 (COVID‐19) has evolved into a pandemic infectious disease transmitted by the severe acute respiratory syndrome coronavirus (SARS‐CoV‐2). Allergists and other healthcare providers (HCPs) in the field of allergies and associated airway diseases are on the front line, taking care of patients potentially infected with SARS‐CoV‐2. Hence, strategies and practices to minimize risks of infection for both HCPs and treated patients have to be developed and followed by allergy clinics. Method: The scientific information on COVID‐19 was analysed by a literature search in MEDLINE, PubMed, the National and International Guidelines from the European Academy of Allergy and Clinical Immunology (EAACI), the Cochrane Library, and the internet. Results: Based on the diagnostic and treatment standards developed by EAACI, on international information regarding COVID‐19, on guidelines of the World Health Organization (WHO) and other international organizations, and on previous experience, a panel of experts including clinicians, psychologists, IT experts, and basic scientists along with EAACI and the "Allergic Rhinitis and its Impact on Asthma (ARIA)" initiative have developed recommendations for the optimal management of allergy clinics during the current COVID‐19 pandemic. These recommendations are grouped into nine sections on different relevant aspects for the care of patients with allergies. Conclusions: This international Position Paper provides recommendations on operational plans and procedures to maintain high standards in the daily clinical care of allergic patients while ensuring the necessary safety measures in the current COVID‐19 pandemic. [ABSTRACT FROM AUTHOR]
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- 2021
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3. Placebo effects in allergen immunotherapy—An EAACI Task Force Position Paper.
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Pfaar, Oliver, Agache, Ioana, Bergmann, Karl‐Christian, Bindslev‐Jensen, Carsten, Bousquet, Jean, Creticos, Peter S., Devillier, Philippe, Durham, Stephen R., Hellings, Peter, Kaul, Susanne, Kleine‐Tebbe, Jörg, Klimek, Ludger, Jacobsen, Lars, Jutel, Marek, Muraro, Antonella, Papadopoulos, Nikolaos G., Rief, Winfried, Scadding, Glenis K., Schedlowski, Manfred, and Shamji, Mohamed H.
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PLACEBOS , *TASK forces , *ALLERGENS , *CLINICAL trials , *IMMUNOTHERAPY - Abstract
The placebo (Latin "I will please") effect commonly occurs in clinical trials. The psychological and physiological factors associated with patients' expectations about a treatment's positive and negative effects have yet to be well characterized, although a functional prefrontal cortex and intense bidirectional communication between the central nervous system and the immune system appear to be prerequisites for a placebo effect. The use of placebo raises certain ethical issues, especially if patients in a placebo group are denied an effective treatment for a long period of time. The placebo effect appears to be relatively large (up to 77%, relative to pretreatment scores) in controlled clinical trials of allergen immunotherapy (AIT), such as the pivotal, double‐blind, placebo‐controlled (DBPC) randomized clinical trials currently required by regulatory authorities worldwide. The European Academy of Allergy and Clinical Immunology (EAACI) therefore initiated a Task Force, in order to better understand the placebo effect in AIT and its specific role in comorbidities, blinding issues, adherence, measurement time points, variability and the natural course of the disease. In this Position Paper, the EAACI Task Force highlights several important topics regarding the placebo effect in AIT such as a) regulatory aspects, b) neuroimmunological and psychological mechanisms, c) placebo effect sizes in AIT trials, d) methodological limitations in AIT trial design and e) potential solutions in future AIT trial design. In conclusion, this Position Paper aims to examine the methodological problem of placebo in AIT from different aspects and also to highlight unmet needs and possible solutions for future trials. [ABSTRACT FROM AUTHOR]
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- 2021
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4. Management of KPC-producing Klebsiella pneumoniae infections.
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Bassetti, M., Giacobbe, D.R., Giamarellou, H., Viscoli, C., Daikos, G.L., Dimopoulos, G., De Rosa, F.G., Giamarellos-Bourboulis, E.J., Rossolini, G.M., Righi, E., Karaiskos, I., Tumbarello, M., Nicolau, D.P., Viale, P.L., and Poulakou, G.
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KLEBSIELLA pneumoniae , *PNEUMONIA treatment , *PHYSICIANS , *DEATH rate , *CLINICAL trials - Abstract
Background Klebsiella pneumoniae carbapenemase (KPC)-producing K. pneumoniae (KPC-KP) has become one of the most important contemporary pathogens, especially in endemic areas. Aims To provide practical suggestion for physicians dealing with the management of KPC-KP infections in critically ill patients, based on expert opinions. Sources PubMed search for relevant publications related to the management of KPC-KP infections. Contents A panel of experts developed a list of 12 questions to be addressed. In view of the current lack of high-level evidence, they were asked to provide answers on the bases of their knowledge and experience in the field. The panel identified several key aspects to be addressed when dealing with KPC-KP in critically ill patients (preventing colonization in the patient, preventing infection in the colonized patient and colonization of his or her contacts, reducing mortality in the infected patient by rapidly diagnosing the causative agent and promptly adopting the best therapeutic strategy) and provided related suggestions that were based on the available observational literature and the experience of panel members. Implications Diagnostic technologies could speed up the diagnosis of KPC-KP infections. Combination treatment should be preferred to monotherapy in cases of severe infections. For non–critically ill patients without severe infections, results from randomized clinical trials are needed for ultimately weighing benefits and costs of using combinations rather than monotherapy. Multifaceted infection control interventions are needed to decrease the rates of colonization and cross-transmission of KPC-KP. [ABSTRACT FROM AUTHOR]
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- 2018
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5. COVID-19 pandemic
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W. J. Fokkens, Jürgen Schwarze, Cezmi A. Akdis, J Mullol, W. Czarlewski, Claudia Traidl-Hoffmann, Claus Bachert, D. Larenas-Linnemann, Tomas Chivato, M. Gotua, Mateo Bonini, Ludger Klimek, Vincenzo Patella, A. A. Cruz, Stephanie Dramburg, Kari C. Nadeau, H W Fritsch, K. Ohta, Thomas Eiwegger, Robert M. Naclerio, Antti Lauerma, A. Yorgancioglu, Aslı Gelincik, Piotr Kuna, Oliver Pfaar, Carmen Riggioni, Violeta Kvedariene, Markus Ollert, Sinthia Bosnic-Anticevich, V. Cardona, S. Del Giacco, Sanna Toppila-Salmi, Helen A. Brough, Heimo Breiteneder, Valérie Hox, B. Samolinski, Zuzana Diamant, G.W. Canonica, Lihong Zhang, María José Torres, Y. Okamoto, Liam O'Mahony, Radosław Gawlik, Jolanta Walusiak-Skorupa, Sharon Chinthrajah, Winfried Rief, T. Haatela, M. Morais-Almeida, Ioana Agache, Manfred Schedlowski, I Skypala, R. Brehler, D. Y. Wang, João Fonseca, I. J. Ansotegui, Robyn E O'Hehir, Oscar Palomares, Charlotte G. Mortz, J. C. Ivancevich, C. Suppli Ulrik, M. T. Ventura, P M Matricardi, S Untersmayr, Gabrielle L. Onorato, Amir Hamzah Abdul Latiff, Frederico S. Regateiro, Vanitha Sampath, Arũnas Valiulis, Marek Jutel, Luisa Brussino, Pedro Carreiro-Martins, Jean Bousquet, Nikolaos G. Papadopoulos, A. Bedbrook, Torsten Zuberbier, Karin Hoffmann-Sommergruber, Edward F. Knol, Ear, Nose and Throat, AII - Inflammatory diseases, UCL - SSS/IREC/PNEU - Pôle de Pneumologie, ORL et Dermatologie, UCL - (SLuc) Service d'oto-rhino-laryngologie, Philipps Universität Marburg = Philipps University of Marburg, Allergologie, Stimm und Sprachstörungen [Wiesbaden, Germany], Zentrum für Rhinologie und Allergologie [Wiesbaden, Germany], University of Wrocław [Poland] (UWr), ALL-MED, Swiss Institute of Allergy and Asthma Research (SIAF), Universität Zürich [Zürich] = University of Zurich (UZH), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Contre les MAladies Chroniques pour un VIeillissement Actif en Languedoc-Roussillon (MACVIA-LR), Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-European Innovation Partnership on Active and Healthy Ageing Reference Site (EIP on AHA), Commission Européenne-Commission Européenne-Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), Medizinische Universität Wien = Medical University of Vienna, Stanford University, Skane University Hospital [Malmo], Lund University [Lund], Charles University [Prague] (CU), University Medical Center Groningen [Groningen] (UMCG), Univ Toronto, Hosp Sick Children, Peter Gilgan Ctr Res & Learning, Mol Med, Toronto, ON M5G 0A4, Canada, The Hospital for sick children [Toronto] (SickKids), University of Toronto, Amsterdam UMC - Amsterdam University Medical Center, Alfred Health, Victoria University [Melbourne], University College Cork (UCC), Sean N. Parker Center for Allergy and Asthma Research [Stanford], Stanford Medicine, Stanford University-Stanford University, University Clinics of Essen, University of Essen, Allergy Unit [Malaga, Spain] (National Network ARADyAL), Hospital Regional Universitario de Málaga = Regional University Hospital of Malaga [Spain], Helmholtz Zentrum München = German Research Center for Environmental Health, University Hospital Augsburg, National University of Singapore (NUS), Beijing Tongren Hospital, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, National Heart and Lung Institute [London] (NHLI), Imperial College London-Royal Brompton and Harefield NHS Foundation Trust, University Hospital Münster - Universitaetsklinikum Muenster [Germany] (UKM), Evelina London Children's Hospital, King‘s College London, CEU-San Pablo University and HM-Hospitals School of Medicine, University of Cagliari, Medical University of Silesia (SUM), Istanbul University, Cliniques Universitaires Saint-Luc [Bruxelles], University Medical Center [Utrecht], Helsinki University Central Hospital, University of Helsinki, Odense University Hospital (OUH), Luxembourg Institute of Health (LIH), Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM), Hospital Sant Joan de Déu [Barcelona], Institut de Recerca Pediàtrica Hospital Sant Joan de Déu [Barcelona, Spain], University of Edinburgh, NHS Foundation Trust [London], The Royal Marsden, Nofer Institute of Occupational Medicine (NIOM), Hospital Quirónsalud Bizkaia [Bilbao], Ghent University Hospital, Sun Yat-Sen University [Guangzhou] (SYSU), Karolinska Institutet [Stockholm], Woolcock Institute of Medical Research [Sydney], The University of Sydney, University of Turin, Mauriziano Umberto I Hospital, Humanitas University [Milan] (Hunimed), Vall d'Hebron University Hospital [Barcelona], Hospital de Dona Estefania, NOVA Medical School - Faculdade de Ciências Médicas (NMS), Universidade Nova de Lisboa = NOVA University Lisbon (NOVA), Federal University of Bahia School of Medicine, Global Alliance Against Chronic Respiratory Diseases (GARD-WHO), Medical Consulting Czarlewski, Faculdade de Medicina da Universidade do Porto (FMUP), Universidade do Porto = University of Porto, MEDIDA, Lda, David Tvildiani Medical University (DTMU), Helsingin yliopisto = Helsingfors universitet = University of Helsinki, Servicio de Alergia e ImmunologiaBuenos Aires (Clinica Santa Isabel), Barlicki University Hospital, Vilnius University [Vilnius], Hospital Medica Sur [Mexico City, Mexico], Pantai Hospital [Kuala Lumpur], Hospital CUF Descobertas, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona (UB), CIBER de Epidemiología y Salud Pública (CIBERESP), Johns Hopkins University School of Medicine [Baltimore], Fukujuji Hospital, Tokyo National Hospital, Chiba Rosai Hospital, Chiba University Hospital, Royal Manchester Children's Hospital, University of Manchester [Manchester], General Children's Hospital of Athens P & A Kyriakou, 'Santa Maria della Speranza' Hospital, Centro Hospitalar e Universitário [Coimbra], Coimbra Institute for Clinical and Biomedical Research [Coimbra, Portugal] (iCBR - Faculty of Medicine), University of Coimbra [Portugal] (UC), Medical University of Warsaw - Poland, Hvidovre Hospital, University of Copenhagen = Københavns Universitet (UCPH), Università degli studi di Bari Aldo Moro = University of Bari Aldo Moro (UNIBA), Manisa Celal Bayar University, Transilvania University of Brasov, Salvy-Córdoba, Nathalie, Department of Dermatology, Allergology and Venereology, and HUS Inflammation Center
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0301 basic medicine ,viruses ,Eaaci Position Paper ,Medizin ,Cochrane Library ,GUIDELINES ,FOOD ALLERGY ,allergen immunotherapy ,allergy clinic ,anaphylaxis ,asthma ,clinical trials ,COVID-19 ,Position Paper ,psychological impact ,SARS-CoV-2 ,Allergists ,Health Personnel ,Humans ,Hypersensitivity ,Information Technology ,Patient Care Team ,Triage ,SARS‐CoV‐2 ,DESENSITIZATION ,0302 clinical medicine ,MESH: Patient Care Team ,[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases ,HDE ALER ,Pandemic ,Health care ,Immunology and Allergy ,ATOPIC-DERMATITIS ,MESH: COVID-19 ,[SDV.IMM.ALL]Life Sciences [q-bio]/Immunology/Allergology ,[SDV.MHEP.ME] Life Sciences [q-bio]/Human health and pathology/Emerging diseases ,[SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases ,allergen immunotherapy (AIT) ,virus diseases ,DRUG HYPERSENSITIVITY REACTIONS ,3. Good health ,INFECTIONS ,[SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases ,MESH: Triage ,[SDV.IMM.ALL] Life Sciences [q-bio]/Immunology/Allergology ,Allergen immunotherapy ,medicine.medical_specialty ,MESH: Information Technology ,MESH: Hypersensitivity ,Immunology ,education ,MEDLINE ,DIAGNOSIS ,psychological COVID ,03 medical and health sciences ,MESH: Allergists ,COVID‐19 ,medicine ,MESH: SARS-CoV-2 ,ddc:610 ,RHINOSINUSITIS ,MESH: Humans ,business.industry ,Clinical trial ,Coronavirus ,EXACERBATIONS ,030104 developmental biology ,030228 respiratory system ,[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie ,Family medicine ,3121 General medicine, internal medicine and other clinical medicine ,Position paper ,MESH: Health Personnel ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,business - Abstract
BackgroundThe Coronavirus disease 2019 (COVID‐19) has evolved as a pandemic infectious disease transmitted by the severe acute respiratory syndrome coronavirus (SARS‐CoV‐)2. Allergists and other health care providers (HCPs) in the field of allergies and associated airway diseases are in the front line, taking care of patients potentially infected with SARS‐CoV‐2. Hence, strategies and practices to minimize risks of infection for both HCPs and treated patients have to be developed and followed by allergy clinics.MethodThe scientific information on COVID‐19 was analyzed by a literature search in Medline, Pubmed, national and international guidelines from the European Academy of Allergy and Clinical Immunology (EAACI), the Cochrane Library and the Internet.ResultsBased on diagnostic and treatment standards developed by EAACI, on international information regarding COVID‐19, on guidelines of the World Health Organization (WHO) and other international organizations as well as on previous experience, a panel of experts including clinicians, psychologists, IT experts and basic scientists along with EAACI and the “Allergic Rhinitis and its Impact on Asthma (ARIA)” inititiative have developed recommendations for the optimal management of allergy clinics during the current COVID‐19 pandemic. These recommendations are grouped into nine sections on different relevant aspects for the care of patients with allergies.ConclusionsThis international Position Paper provides recommendations on operational plans and procedures to maintain high standards in the daily clinical care of allergic patients whilst ensuring necessary safety in the current COVID‐19 pandemic.
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- 2021
6. Position paper on requirements for toxicological studies in the specific case of radiopharmaceuticals.
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Koziorowski, J., Behe, M., Decristoforo, C., Ballinger, J., Elsinga, P., Ferrari, V., Kolenc Peitl, P., Todde, S., and Mindt, T.
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RADIOPHARMACEUTICALS , *CLINICAL trials , *PHARMACEUTICAL industry , *TOXICITY testing , *DRUG efficacy - Abstract
This is a position paper of the Radiopharmacy Committee of the EANM (European Association of Nuclear Medicine) addressing toxicology studies for application of new diagnostic and therapeutic radiopharmaceuticals (RP) that are not approved (i.e., not having a marketing authorization or a monograph in the European Pharmacopoeia), excluding endogenous and ubiquitous substances in humans. This paper discusses the requirements for clinical trials with radiopharmaceuticals for clinical research applications, not necessarily intended to aim at a marketing authorization. If marketing authorization is intended, scientific advice of the competent authorities is mandatory and cannot be replaced by this position paper. The position paper reflects the view of the Radiopharmacy Committee of the EANM and can be used as a basis for discussions with the responsible authorities. [ABSTRACT FROM AUTHOR]
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- 2016
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7. Advancing Clinical Trials for Inherited Retinal Diseases: Recommendations from the Second Monaciano Symposium
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Robin R. Ali, James W B Bainbridge, Henry Klassen, John G. Flannery, Eric A. Pierce, Elise Heon, Robert S. Molday, Deniz Dalkara, David G. Birch, Thomas A. Reh, Bart P. Leroy, Paul A. Sieving, Alessandro Iannaccone, Vadim Y. Arshavsky, S.P. Daiger, John R. Heckenlively, K. Thiran Jayasundera, Rajesh C. Rao, Kari Branham, José Sahel, Isabelle Audo, Artur V. Cideciyan, Paul Yang, Simon M. Petersen-Jones, Cagri G. Besirli, Abigail T. Fahim, Jacque L. Duncan, Debra A. Thompson, Mark E. Pennesi, David N. Zacks, Roberto Gattegna, Naheed W. Khan, Dror Sharon, David C. Musch, and Enrica Strettoi
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medicine.medical_specialty ,clinical trials ,Blinding ,Surrogate endpoint ,business.industry ,inherited retinal diseases ,Biomedical Engineering ,Outcome measures ,Review ,counseling patients ,Analysis of clinical trials ,Precision medicine ,Retina ,Clinical trial ,Ophthalmology ,Patient safety ,outcome measures ,Retinal Diseases ,medicine ,Position paper ,Humans ,natural history studies ,Precision Medicine ,Intensive care medicine ,business - Abstract
Major advances in the study of inherited retinal diseases (IRDs) have placed efforts to develop treatments for these blinding conditions at the forefront of the emerging field of precision medicine. As a result, the growth of clinical trials for IRDs has increased rapidly over the past decade and is expected to further accelerate as more therapeutic possibilities emerge and qualified participants are identified. Although guided by established principles, these specialized trials, requiring analysis of novel outcome measures and endpoints in small patient populations, present multiple challenges relative to study design and ethical considerations. This position paper reviews recent accomplishments and existing challenges in clinical trials for IRDs and presents a set of recommendations aimed at rapidly advancing future progress. The goal is to stimulate discussions among researchers, funding agencies, industry, and policy makers that will further the design, conduct, and analysis of clinical trials needed to accelerate the approval of effective treatments for IRDs, while promoting advocacy and ensuring patient safety.
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- 2020
8. EORTC elderly task force position paper: Approach to the older cancer patient
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Pallis, A.G., Fortpied, C., Wedding, U., Van Nes, M.C., Penninckx, B., Ring, A., Lacombe, D., Monfardini, S., Scalliet, P., and Wildiers, H.
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GERIATRIC oncology , *DISEASES in older people , *CLINICAL trials , *DISEASE incidence , *CANCER treatment ,AGE factors in cancer - Abstract
As a result of an increasing life expectancy, the incidence of cancer cases diagnosed in the older population is rising. Indeed, cancer incidence is 11-fold higher in persons over the age of 65 than in younger ones. Despite this high incidence of cancer in older patients, solid data regarding the most appropriate approach and best treatment for older cancer patients are still lacking, mostly due to under-representation of these patients in prospective clinical trials. The clinical behaviour of common malignant diseases, e.g. breast, ovarian and lung cancers, lymphomas and acute leukaemias, may be different in older patients because of intrinsic variation of the neoplastic cells and the ability of the tumour host to support neoplastic growth. The decision to treat or not these patients should be based on patients’ functional age rather than the chronological age. Assessment of patients’ functional age includes the evaluation of health, functional status, nutrition, cognition and the psychosocial and economic context. The purpose of this paper is to focus on the influence of age on cancer presentation and cancer management in older cancer patients and to provide suggestions on clinical trial development and methodology in this population. [Copyright &y& Elsevier]
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- 2010
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9. Use of Placebo in Pediatric Inflammatory Bowel Diseases
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Michael J. Lentze, Sibylle Koletzko, Patrick F. van Rheenen, Paolo Lionetti, Johanna C. Escher, Berthold Koletzko, Gigi Veereman, Frank M. Ruemmele, Marla Dubinsky, Anne M. Griffiths, David R. Mack, Severine Vermeire, Salvatore Cucchiara, Lissy de Ridder, Dan Turner, Richard K. Russell, Jeffrey S. Hyams, Center for Liver, Digestive and Metabolic Diseases (CLDM), Pediatrics, Clinical sciences, and Growth and Development
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Pathology ,Placebos ,0302 clinical medicine ,Maintenance therapy ,SEVERE CROHNS-DISEASE ,European Medicines Agency ,European Society for Pediatric Gastroenterology ,EPISODIC TREATMENT ,Child ,Clinical Trials as Topic ,Gastroenterology ,European Crohn's and Colitis Organization ,Ulcerative colitis ,Europe ,ULCERATIVE-COLITIS ,Research Design ,030220 oncology & carcinogenesis ,Therapeutic Equipoise ,030211 gastroenterology & hepatology ,TRIAL ,medicine.drug ,medicine.medical_specialty ,Canada ,Consensus ,pediatrics ,Placebo ,gastroenterology ,perinatology and child health ,03 medical and health sciences ,Pediatric Inflammatory Bowel Diseases, Placebo ,INFLIXIMAB ,medicine ,Adalimumab ,Humans ,Intensive care medicine ,Pediatric gastroenterology ,METAANALYSIS ,and Nutrition ,clinical trials ,Hepatology ,business.industry ,Consensus Development Conference ,Drugs, Investigational ,medicine.disease ,Inflammatory Bowel Diseases ,CONSENSUS GUIDELINES ,US Food and Drug Administration ,Infliximab ,Clinical trial ,Human Experimentation ,Pediatric Inflammatory Bowel Disease Network (PIBDnet) ,MAINTENANCE ,Pediatrics, Perinatology and Child Health ,Position paper ,MODERATE ,business ,ADALIMUMAB - Abstract
Performing well-designed and ethical trials in pediatric inflammatory bowel diseases (IBD) is a priority to support optimal therapy and reduce the unacceptable long lag between adult and pediatric drug approval. Recently, clinical trials in children have been incorporating placebo arms into their protocols under conditions that created controversy. Therefore, 4 organizations (the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition; European Crohn's and Colitis Organization; the Canadian Children IBD Network; and the Global Pediatric IBD Network) jointly provide a statement on the role of placebo in pediatric IBD trials. Consensus was achieved by 94 of 100 (94%) voting committees' members that placebo should only be used if there is genuine equipoise between the active treatment and placebo; for example, this may be considered in trials of drugs with new mechanisms of action without existing adult data, especially when proven effective alternatives do not exist outside the trial. Placebo may also be used in situations where it is an add-on to an effective therapy or to evaluate exit-strategies of maintenance therapy after long-term deep remission. It has been, however, agreed that no child enrolled in a trial should receive a known inferior treatment both within and outside the trial. This also includes withholding therapy in children who show clinical response after a short induction therapy. Given the similarity between pediatric and adult IBD regarding pathophysiology and response to treatments, drugs generally cannot be considered being in genuine equipoise with placebo if it has proven efficacy in adults. Continued collaboration of all stakeholders is needed to facilitate drug development and evaluation in pediatric IBD.
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- 2016
10. Surgical quality assurance in head and neck cancer trials: an EORTC Head and Neck Cancer Group position paper based on the EORTC 1420 'Best of' and 24954 'larynx preservation' study
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Christian Simon, C. René Leemans, Piero Nicolai, Petri Koivunen, Marc Hamoir, Dietmar Thurnher, Andreas Dietz, Philippe Ceruse, Guy Andry, Vincent Grégoire, Keith K.A. Hunter, Lisa Licitra, Hisham Mehanna, Carmela Caballero, Giuseppe Spriano, Jean-Pascal Machiels, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Centre du cancer, and UCL - (SLuc) Unité d'oncologie médicale
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Cancer Research ,medicine.medical_specialty ,Clinical trials ,EORTC ,Head and neck cancer ,Quality assurance ,Surgery ,Quality management ,Quality Assurance, Health Care ,medicine.medical_treatment ,03 medical and health sciences ,0302 clinical medicine ,Surgical oncology ,Medicine ,Humans ,Medical physics ,030223 otorhinolaryngology ,Protocol (science) ,business.industry ,medicine.disease ,Quality Improvement ,Radiation therapy ,Clinical trial ,Oncology ,Head and Neck Neoplasms ,030220 oncology & carcinogenesis ,Position paper ,business - Abstract
Quality improvement of care for patients with head and neck cancer remains a constant objective for the multidisciplinary team of physicians managing these patients. The purpose of quality assurance (QA) for head and neck surgical oncology and surgical trials however differs. While QA for the general head and neck patient aims to improve global outcome through structural changes of health-care systems, QA for surgical trials pursues the goal to help providing meaningful results from a clinical trial through the definition of structure, process and outcome measures within the trial. Establishing a QA program for surgical trials is challenging largely due to the variation in the execution of surgical techniques. Within this article, we describe the surgical QA program, which was developed for the phase III European Organisation for Research and Treatment of Cancer (EORTC) 1420 study, a trial assessing swallowing function after transoral surgery compared with radiation therapy. We propose based on our experience to further develop surgical QA for surgical clinical trials by introducing two separate components, one adaptable and one non-adaptable. The adaptable is tailored to the scientific question and specific procedure; the non-adaptable consists of minimal structural requirements of the clinical unit to participate in surgical trials at EORTC as well as guidelines and incentives for protocol adherence based on our experience in EORTC 24954. Finally, we strongly believe that surgical QA designed for clinical trials may serve as a basis for the development of QA surgical guidelines in clinical practice.
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- 2018
11. Position statement on radiopharmaceutical production for clinical trials
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M. S. Cooper, M. Desruet, R. Schiavo, Arturo Chiti, Vijay Kumar, Sally W. Schwarz, Albert D. Windhorst, Y. Liu, Iván Peñuelas, A. Buck, J. Croasdale, Guy Bormans, C. Rossetti, Medical psychology, Radiology and nuclear medicine, Amsterdam Neuroscience - Brain Imaging, CCA - Cancer biology and immunology, CCA - Imaging and biomarkers, CCA - Treatment and quality of life, CCA - Evaluation of Cancer Care, CCA - Imaging, and CCA - Target Discovery & Preclinial Therapy Development
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Position statement ,lcsh:Medical physics. Medical radiology. Nuclear medicine ,medicine.medical_specialty ,lcsh:R895-920 ,Eu countries ,030218 nuclear medicine & medical imaging ,Analytical Chemistry ,03 medical and health sciences ,0302 clinical medicine ,Clinical trials ,Medicine ,Production (economics) ,Pharmacology (medical) ,Radiology, Nuclear Medicine and imaging ,Medical physics ,Pharmacology ,business.industry ,lcsh:RM1-950 ,THERAPEUTIC RADIOPHARMACEUTICALS ,Regulatory ,Clinical trial ,lcsh:Therapeutics. Pharmacology ,Work (electrical) ,Risk analysis (engineering) ,030220 oncology & carcinogenesis ,Position Paper ,Radiopharmaceuticals ,business ,Diagnostic radiopharmaceuticals - Abstract
The EU regulation 536/2014 aims to facilitate the experimental use of diagnostic radiopharmaceuticals in particular for GMP requirements and needs to be applied in EU countries. As definitely clarified by this survey, the application is still far from being completed due to national restrictions that are conflicting with the content of the above EU regulation. Although the nuclear medicine centers are obliged to be compliant with national regulatory, national authorities have to be required to work towards full application of the regulation. On the other hand, an update of 536/2014 that includes therapeutic radiopharmaceuticals would also be beneficial to a rational and safe advance of nuclear medicine.
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- 2017
12. Allergen exposure chambers: harmonizing current concepts and projecting the needs for the future - an EAACI Position Paper
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Friedrich Horak, P. Zieglmayer, Robert L. Jacobs, Lars Jacobsen, Moises A. Calderon, D. Larenas-Linnemann, J. Yang, T. Zuberbier, Oliver Pfaar, Torben Sigsgaard, S. Kaul, Hendrik Nolte, Jakob Hjort Bønløkke, Mark Larché, Cynthia G. Rather, K. C. Bergmann, L. Peoples, Ralph Mösges, S. Thaarup, Ronald L. Rabin, Anne K. Ellis, Philippe Devillier, E. Angjeli, F. De Blay, Charles P. Andrews, Pascal Demoly, Piyush Patel, R. Gerth van Wijk, Anne-Marie Salapatek, Jens M. Hohlfeld, Marek Jutel, Publica, CHU Strasbourg, Mitochondrie, stress oxydant et protection musculaire (MSP), Université de Strasbourg (UNISTRA), Hôpital Foch [Suresnes], Laboratoire de recherche sur les mécanismes moléculaires et pharmacologiques de l’obstruction bronchique (LOBIP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Département pneumologie et addictologie [Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Arnaud de Villeneuve, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Internal Medicine
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0301 basic medicine ,medicine.medical_specialty ,Standardization ,Clinical immunology ,Immunology ,education ,allergic ,Marketing authorization ,Unmet needs ,03 medical and health sciences ,0302 clinical medicine ,rhinitis ,Hypersensitivity ,Immunology and Allergy ,Medicine ,Humans ,Medical physics ,allergen exposure chambers ,[SDV.IMM.ALL]Life Sciences [q-bio]/Immunology/Allergology ,validation ,Inhalation Exposure ,clinical trials ,Task force ,business.industry ,Health Policy ,Reproducibility of Results ,Allergens ,respiratory system ,Environment, Controlled ,3. Good health ,Clinical trial ,030104 developmental biology ,030228 respiratory system ,Desensitization, Immunologic ,Position paper ,ALLERGEN EXPOSURE ,business - Abstract
BACKGOUND: Allergen exposure chambers (AEC) are clinical facilities allowing for controlled exposure of subjects to allergens in an enclosed environment. AEC have contributed towards characterizing the pathophysiology of respiratory allergic diseases and the pharmacological properties of new therapies. In addition, they are complementary to and offer some advantages over traditional multi-centre field trials for evaluation of novel therapeutics. To date, AEC studies conducted have been monocentric and have followed protocols unique to each center. Because there are technical differences among AEC, it may be necessary to define parameters to standardize the AEC so that studies may be extrapolated for driving basic immunological research and for marketing authorization purposes by regulatory authorities.METHODS: For this task force initiative of the European Academy of Allergy and Clinical Immunology (EAACI) experts from academia and regulatory agencies met with chamber operators to list technical, clinical and regulatory unmet needs as well as the prerequisites for clinical validation.RESULTS: The latter covered the validation process, standardization of challenges and outcomes, intra- and inter-chamber variability and reproducibility, in addition to comparability with field trials and specifics of paediatric trials and regulatory issues.CONCLUSION: This EAACI Position Paper aims to harmonize current concepts in AEC and to project unmet needs with the intent to enhance progress towards use of these facilities in determining safety and efficacy of new therapeutics in the future. This article is protected by copyright. All rights reserved.
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- 2017
13. Recommendations for the conduct of clinical trials for drugs to treat or prevent sarcopenia
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Roger A. Fielding, Bruno Flamion, Heike A. Bischoff-Ferrari, John A. Kanis, Suzanne Reiter-Niesert, Olivier Bruyère, Marjolein Visser, Maarten Boers, Eugene V. McCloskey, René Rizzoli, Cyrus Cooper, Alfonso J. Cruz-Jentoft, Jean-Yves Reginster, Ivan Bautmans, Yannis Tsouderos, Alberto Pilotto, Bruce H. Mitlak, Geoff Appelboom, Andrea Ildiko Gasparik, Yves Rolland, Antonio Cherubini, Luc J. C. van Loon, Maria Luisa Brandi, Epidemiology and Data Science, Rheumatology, Internal medicine, EMGO - Lifestyle, overweight and diabetes, Gerontology, Rehabilitation Research, Frailty in Ageing, Research in Geriatrics and Gerontology, Human Physiology and Sports Physiotherapy Research Group, Physiotherapy, Human Physiology and Anatomy, University of Zurich, and Bruyère, Olivier
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Research design ,Gerontology ,Aging ,medicine.medical_specialty ,Sarcopenia ,11221 Clinic for Geriatric Medicine ,Medication Therapy Management ,Alternative medicine ,Non-P.H.S ,610 Medicine & health ,2717 Geriatrics and Gerontology ,030209 endocrinology & metabolism ,Review ,Clinical trials ,Frailty ,Preventative health care ,Public health ,Aged ,Clinical Trials as Topic ,Humans ,Practice Guidelines as Topic ,Research Design ,Geriatrics and Gerontology ,Research Support ,Older population ,03 medical and health sciences ,1302 Aging ,0302 clinical medicine ,SDG 17 - Partnerships for the Goals ,Medication therapy management ,medicine ,Journal Article ,030212 general & internal medicine ,business.industry ,medicine.disease ,Clinical trial ,Ageing ,ddc:618.97 ,Position paper ,U.S. Gov't ,business ,Research Support, U.S. Gov't, Non-P.H.S - Abstract
Purpose Sarcopenia is an age-related muscle condition which is frequently a precursor of frailty, mobility disability and premature death. It has a high prevalence in older populations and presents a considerable social and economic burden. Potential treatments are under development but, as yet, no guidelines support regulatory studies for new drugs to manage sarcopenia. The objective of this position paper is therefore to suggest a set of potential endpoints and target population definitions to stimulate debate and progress within the medico-scientific and regulatory communities. Methods A multidisciplinary expert working group was hosted by the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis, which reviewed and discussed the recent literature from a perspective of clinical experience and guideline development. Relevant parallels were drawn from the development of definition of osteoporosis as a disease and clinical assessment of pharmaceutical treatments for that indication. Results A case-finding decision tree is briefly reviewed with a discussion of recent prevalence estimations of different relevant threshold values. The selection criteria for patients in regulatory studies are discussed according to the aims of the investigation (sarcopenia prevention or treatment) and the stage of project development. The possible endpoints of such studies are reviewed and a plea is made for the establishment of a core outcome set to be used in all clinical trials of sarcopenia. Conclusions The current lack of guidelines for the assessment of new therapeutic treatments for sarcopenia could potentially hinder the delivery of effective medicines to patients at risk. Electronic supplementary material The online version of this article (doi:10.1007/s40520-015-0517-y) contains supplementary material, which is available to authorized users.
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- 2016
14. Improving clinical trials for cardiovascular diseases: a position paper from the Cardiovascular Round Table of the European Society of Cardiology
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Dominik Lautsch, Nilesh J. Samani, Guenter Breithardt, Dan Atar, Matthias Endres, Peter G. M. Mol, Hakima Hannachi, Maria Borentain, Anders Svensson, Andrew Zalewski, Paulus Kirchhof, Chantal Le Floch, Uwe Fraass, Salim Janmohamed, Jackson Neville Colin, Huseyin Naci, Martin J Landray, Jan G.P. Tijssen, Joerg Kreuzer, Tim Friede, Cathrine Thorstensen, Martin van Eickels, Victoria Vandzhura, Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), and Cardiology
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Technology Assessment, Biomedical ,MONOCLONAL-ANTIBODY ,030204 cardiovascular system & hematology ,Cardiovascular ,PLACEBO-CONTROLLED TRIAL ,DOUBLE-BLIND ,0302 clinical medicine ,Clinical trials ,Cost of Illness ,Drug Discovery ,Medicine ,030212 general & internal medicine ,Precision Medicine ,Health technology assessment ,Drug Approval ,New therapies ,Societies, Medical ,Pharmaceutical industry ,Clinical Trials as Topic ,Cardiovascular disease burden ,Data Collection ,Therapies, Investigational ,Health technology ,C-REACTIVE PROTEIN ,Europe ,KEY DATA ELEMENTS ,Drug development ,Cardiovascular Diseases ,Costs and Cost Analysis ,Cardiology ,Cardiology and Cardiovascular Medicine ,medicine.medical_specialty ,Drug Industry ,Interprofessional Relations ,HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA ,03 medical and health sciences ,Internal medicine ,Humans ,CORONARY-HEART-DISEASE ,ASSOCIATION TASK-FORCE ,business.industry ,SUBTILISIN/KEXIN TYPE 9 ,Information technology ,Personalized medicine ,Clinical trial ,HIGH-RISK ,Cardiovascular agent ,Position paper ,business - Abstract
Aims Cardiovascular disease is the most common cause of mortality and morbidity in the world, but the pharmaceutical industry's willingness to invest in this field has declined because of the many challenges involved with bringing new cardiovascular drugs to market, including late-stage failures, escalating regulatory requirements, bureaucracy of the clinical trial business enterprise, and limited patient access after approval. This contrasts with the remaining burden of cardiovascular disease in Europe and in the world. Thus, clinical cardiovascular research needs to adapt to address the impact of these challenges in order to ensure development of new cardiovascular medicines.Methods and results The present paper is the outcome of a two-day workshop held by the Cardiovascular Round Table of the European Society of Cardiology. We propose strategies to improve development of effective new cardiovascular therapies. These can include (i) the use of biomarkers to describe patients who will benefit from new therapies more precisely, achieving better human target validation; (ii) targeted, mechanism-based approaches to drug development for defined populations; (iii) the use of information technology to simplify data collection and follow-up in clinical trials; (iv) streamlining adverse event collection and reducing monitoring; (v) extended patent protection or limited rapid approval of new agents to motivate investment in early phase development; and (vi) collecting data needed for health technology assessment continuously throughout the drug development process (before and after approval) to minimize delays in patient access. Collaboration across industry, academia, regulators, and payers will be necessary to enact change and to unlock the existing potential for cardiovascular clinical drug development.Conclusions A coordinated effort involving academia, regulators, industry, and payors will help to foster better and more effective conduct of clinical cardiovascular trials, supporting earlier availability of innovative therapies and better management of cardiovascular diseases.
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- 2015
15. Rare Cancers Europe (RCE) methodological recommendations for clinical studies in rare cancers: A European consensus position paper
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Casali, Paolo G., Bruzzi, P., Bogaerts, Jan, Blay, Jean-Yves, Aapro, M. S., Adamou, A., Berruti, A., Bressington, J., Bruzzi, B., Capocaccia, R., Cardoso, Fatima, Celis, J. E., Cervantes, A., Ciardiello, F., Claussen, C., Coleman, M., Comis, S., Craine, S., Boltz, D. De, Lorenzo, F. De, P, Angelo Dei Tos, Gatta, G., Geissler, J., Giuliani, R., Grande, E., Gronchi, A., Jezdic, S., Jonsson, B., Jost, Lorenz M., Keulen, H., Lacombe, D., Lamory, G., Cam, Y. Le, Priolo, S. Leto di, Licitra, Lisa, Macchia, F., Margulies, A., Marreaud, S., McVie, G., Narbutas, S., Oliver, K., Pavlidis, Nicholas, Pelouchova, J., Pentheroudakis, George, Piccart, M., Pierotti, M. A., Pravettoni, G., Redmond, K., Riegman, P., Ruffilli, M. P., Ryner, D., Sandrucci, S., Seymour, M., Torri, V., Trama, A., Belle, S. Van, Vassal, G., Wartenberg, M., Watts, C., Wilson, A., Yared, W., Pavlidis, Nicholas [0000-0002-2195-9961], and Pentheroudakis, George [0000-0002-6632-2462]
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Research design ,Pathology ,Data base ,Research methodology ,Electronic medical record ,Disease ,Review ,Procedures ,Treatment response ,Clinical trials ,Rare cancers ,Clinical Studies as Topic ,Humans ,Neoplasms ,Rare Diseases ,Research Design ,Hematology ,Oncology ,Reimbursement ,Priority journal ,education.field_of_study ,Clinical studies as topic ,Rare diseases ,Europe ,Clinical decision making ,Human ,medicine.medical_specialty ,Practice guideline ,Case finding ,Population ,Health care quality ,Reviews ,Cancer research ,Clinical study ,SDG 3 - Good Health and Well-being ,Conceptual framework ,medicine ,Tumor marker ,Intensive care medicine ,education ,Antineoplastic activity ,Flexibility (engineering) ,Surrogate endpoint ,business.industry ,Methodology ,Rare cancer ,Study design ,Cancer survival ,Clinical trial ,Patient information ,Clinical effectiveness ,Position paper ,Neoplasm ,business ,Rare disease - Abstract
While they account for one-fifth of new cancer cases, rare cancers are difficult to study. A higher than average degree of uncertainty should be accommodated for clinical as well as for population-based decision making. Rules of rational decision making in conditions of uncertainty should be rigorously followed and would need widely informative clinical trials. In principle, any piece of new evidence would need to be exploited in rare cancers. Methodologies to explicitly weigh and combine all the available evidence should be refined, and the Bayesian logic can be instrumental to this end. Likewise, Bayesian-design trials may help optimize the low number of patients liable to be enrolled in clinical studies on rare cancers, as well as adaptive trials in general, with their inherent potential of flexibility when properly applied. While clinical studies are the mainstay to test hypotheses, the potential of electronic patient records should be exploited to generate new hypotheses, to create external controls for future studies (when internal controls are unpractical), to study effectiveness of new treatments in real conditions. Framework study protocols in specific rare cancers to stepwisely test sets of new agents, as from the early post-phase I development stage, should be encouraged. Also the compassionate and the off-label settings should be exploited to generate new evidence, and flexible regulatory innovations such as adaptive licensing could convey new agents early to rare cancer patients, while generating evidence. Though validation of surrogate end points is problematic in rare cancers, the use of an updated notion of tumor response may be of great value in the single patient to optimize the use of therapies, all the more the new ones. Disease-based communities, involving clinicians and patients, should be regularly consulted by regulatory bodies when setting their policies on drug approval and reimbursement in specific rare cancers ., While they account for one-fifth of new cancer cases, rare cancers are difficult to study. A higher than average degree of uncertainty should be accommodated for clinical as well as for population-based decision making. Rules of rational decision making in conditions of uncertainty should be rigorously followed and would need widely informative clinical trials. In principle, any piece of new evidence would need to be exploited in rare cancers. Methodologies to explicitly weigh and combine all the available evidence should be refined, and the Bayesian logic can be instrumental to this end. Likewise, Bayesian-design trials may help optimize the low number of patients liable to be enrolled in clinical studies on rare cancers, as well as adaptive trials in general, with their inherent potential of flexibility when properly applied. While clinical studies are the mainstay to test hypotheses, the potential of electronic patient records should be exploited to generate new hypotheses, to create external controls for future studies (when internal controls are unpractical), to study effectiveness of new treatments in real conditions. Framework study protocols in specific rare cancers to sequentially test sets of new agents, as from the early post-phase I development stage, should be encouraged. Also the compassionate and the off-label settings should be exploited to generate new evidence, and flexible regulatory innovations such as adaptive licensing could convey new agents early to rare cancer patients, while generating evidence. Though validation of surrogate end points is problematic in rare cancers, the use of an updated notion of tumor response may be of great value in the single patient to optimize the use of therapies, all the more the new ones. Disease-based communities, involving clinicians and patients, should be regularly consulted by regulatory bodies when setting their policies on drug approval and reimbursement in specific rare cancers.
- Published
- 2015
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