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dc.contributor.authorCasali, Paolo G.en
dc.contributor.authorBruzzi, P.en
dc.contributor.authorBogaerts, Janen
dc.contributor.authorBlay, Jean-Yvesen
dc.contributor.authorAapro, M. S.en
dc.contributor.authorAdamou, A.en
dc.contributor.authorBerruti, A.en
dc.contributor.authorBressington, J.en
dc.contributor.authorBruzzi, B.en
dc.contributor.authorCapocaccia, R.en
dc.contributor.authorCardoso, Fatimaen
dc.contributor.authorCelis, J. E.en
dc.contributor.authorCervantes, A.en
dc.contributor.authorCiardiello, F.en
dc.contributor.authorClaussen, C.en
dc.contributor.authorColeman, M.en
dc.contributor.authorComis, S.en
dc.contributor.authorCraine, S.en
dc.contributor.authorBoltz, D. Deen
dc.contributor.authorLorenzo, F. Deen
dc.contributor.authorP, Angelo Dei Tosen
dc.contributor.authorGatta, G.en
dc.contributor.authorGeissler, J.en
dc.contributor.authorGiuliani, R.en
dc.contributor.authorGrande, E.en
dc.contributor.authorGronchi, A.en
dc.contributor.authorJezdic, S.en
dc.contributor.authorJonsson, B.en
dc.contributor.authorJost, Lorenz M.en
dc.contributor.authorKeulen, H.en
dc.contributor.authorLacombe, D.en
dc.contributor.authorLamory, G.en
dc.contributor.authorCam, Y. Leen
dc.contributor.authorPriolo, S. Leto dien
dc.contributor.authorLicitra, Lisaen
dc.contributor.authorMacchia, F.en
dc.contributor.authorMargulies, A.en
dc.contributor.authorMarreaud, S.en
dc.contributor.authorMcVie, G.en
dc.contributor.authorNarbutas, S.en
dc.contributor.authorOliver, K.en
dc.contributor.authorPavlidis, Nicholasen
dc.contributor.authorPelouchova, J.en
dc.contributor.authorPentheroudakis, Georgeen
dc.contributor.authorPiccart, M.en
dc.contributor.authorPierotti, M. A.en
dc.contributor.authorPravettoni, G.en
dc.contributor.authorRedmond, K.en
dc.contributor.authorRiegman, P.en
dc.contributor.authorRuffilli, M. P.en
dc.contributor.authorRyner, D.en
dc.contributor.authorSandrucci, S.en
dc.contributor.authorSeymour, M.en
dc.contributor.authorTorri, V.en
dc.contributor.authorTrama, A.en
dc.contributor.authorBelle, S. Vanen
dc.contributor.authorVassal, G.en
dc.contributor.authorWartenberg, M.en
dc.contributor.authorWatts, C.en
dc.contributor.authorWilson, A.en
dc.contributor.authorYared, W.en
dc.contributor.otherCasali, Paolo G.en
dc.contributor.otherBruzzi, P.en
dc.contributor.otherBogaerts, Janen
dc.contributor.otherBlay, Jean-Yvesen
dc.contributor.otherAapro, M. S.en
dc.contributor.otherAdamou, A.en
dc.contributor.otherBerruti, A.en
dc.contributor.otherBressington, J.en
dc.contributor.otherBruzzi, B.en
dc.contributor.otherCapocaccia, R.en
dc.contributor.otherCardoso, Fatimaen
dc.contributor.otherCelis, J. E.en
dc.contributor.otherCervantes, A.en
dc.contributor.otherCiardiello, F.en
dc.contributor.otherClaussen, C.en
dc.contributor.otherColeman, M.en
dc.contributor.otherComis, S.en
dc.contributor.otherCraine, S.en
dc.contributor.otherBoltz, D. Deen
dc.contributor.otherLorenzo, F. Deen
dc.contributor.otherP, Angelo Dei Tosen
dc.contributor.otherGatta, G.en
dc.contributor.otherGeissler, J.en
dc.contributor.otherGiuliani, R.en
dc.contributor.otherGrande, E.en
dc.contributor.otherGronchi, A.en
dc.contributor.otherJezdic, S.en
dc.contributor.otherJonsson, B.en
dc.contributor.otherJost, Lorenz M.en
dc.contributor.otherKeulen, H.en
dc.contributor.otherLacombe, D.en
dc.contributor.otherLamory, G.en
dc.contributor.otherCam, Y. Leen
dc.contributor.otherPriolo, S. Leto dien
dc.contributor.otherLicitra, Lisaen
dc.contributor.otherMacchia, F.en
dc.contributor.otherMargulies, A.en
dc.contributor.otherMarreaud, S.en
dc.contributor.otherMcVie, G.en
dc.contributor.otherNarbutas, S.en
dc.contributor.otherOliver, K.en
dc.contributor.otherPelouchova, J.en
dc.contributor.otherPentheroudakis, Georgeen
dc.contributor.otherPiccart, M.en
dc.contributor.otherPierotti, M. A.en
dc.contributor.otherPravettoni, G.en
dc.contributor.otherRedmond, K.en
dc.contributor.otherRiegman, P.en
dc.contributor.otherRuffilli, M. P.en
dc.contributor.otherRyner, D.en
dc.contributor.otherSandrucci, S.en
dc.contributor.otherSeymour, M.en
dc.contributor.otherTorri, V.en
dc.contributor.otherTrama, A.en
dc.contributor.otherBelle, S. Vanen
dc.contributor.otherVassal, G.en
dc.contributor.otherWartenberg, M.en
dc.contributor.otherWatts, C.en
dc.contributor.otherWilson, A.en
dc.contributor.otherYared, W.en
dc.creatorCasali, Paolo G.en
dc.creatorBruzzi, P.en
dc.creatorBogaerts, Janen
dc.creatorBlay, Jean-Yvesen
dc.creatorAapro, M. S.en
dc.creatorAdamou, A.en
dc.creatorBerruti, A.en
dc.creatorBressington, J.en
dc.creatorBruzzi, B.en
dc.creatorCapocaccia, R.en
dc.creatorCardoso, Fatimaen
dc.creatorCelis, J. E.en
dc.creatorCervantes, A.en
dc.creatorCiardiello, F.en
dc.creatorClaussen, C.en
dc.creatorColeman, M.en
dc.creatorComis, S.en
dc.creatorCraine, S.en
dc.creatorBoltz, D. Deen
dc.creatorLorenzo, F. Deen
dc.creatorP, Angelo Dei Tosen
dc.creatorGatta, G.en
dc.creatorGeissler, J.en
dc.creatorGiuliani, R.en
dc.creatorGrande, E.en
dc.creatorGronchi, A.en
dc.creatorJezdic, S.en
dc.creatorJonsson, B.en
dc.creatorJost, Lorenz M.en
dc.creatorKeulen, H.en
dc.creatorLacombe, D.en
dc.creatorLamory, G.en
dc.creatorCam, Y. Leen
dc.creatorPriolo, S. Leto dien
dc.creatorLicitra, Lisaen
dc.creatorMacchia, F.en
dc.creatorMargulies, A.en
dc.creatorMarreaud, S.en
dc.creatorMcVie, G.en
dc.creatorNarbutas, S.en
dc.creatorOliver, K.en
dc.creatorPavlidis, Nicholasen
dc.creatorPelouchova, J.en
dc.creatorPentheroudakis, Georgeen
dc.creatorPiccart, M.en
dc.creatorPierotti, M. A.en
dc.creatorPravettoni, G.en
dc.creatorRedmond, K.en
dc.creatorRiegman, P.en
dc.creatorRuffilli, M. P.en
dc.creatorRyner, D.en
dc.creatorSandrucci, S.en
dc.creatorSeymour, M.en
dc.creatorTorri, V.en
dc.creatorTrama, A.en
dc.creatorBelle, S. Vanen
dc.creatorVassal, G.en
dc.creatorWartenberg, M.en
dc.creatorWatts, C.en
dc.creatorWilson, A.en
dc.creatorYared, W.en
dc.date.accessioned2018-06-22T09:52:47Z
dc.date.available2018-06-22T09:52:47Z
dc.date.issued2015
dc.identifier.urihttps://gnosis.library.ucy.ac.cy/handle/7/41511
dc.description.abstractWhile 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 . © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology.en
dc.language.isoengen
dc.sourceAnnals of Oncologyen
dc.subjectEuropeen
dc.subjectMethodologyen
dc.subjectConceptual frameworken
dc.subjectReviewen
dc.subjectHumanen
dc.subjectNeoplasmsen
dc.subjectHumansen
dc.subjectClinical decision makingen
dc.subjectCancer survivalen
dc.subjectPriority journalen
dc.subjectAntineoplastic activityen
dc.subjectCancer researchen
dc.subjectNeoplasmen
dc.subjectProceduresen
dc.subjectResearch designen
dc.subjectTreatment responseen
dc.subjectPractice guidelineen
dc.subjectTumor markeren
dc.subjectClinical trialsen
dc.subjectCase findingen
dc.subjectClinical effectivenessen
dc.subjectClinical studies as topicen
dc.subjectClinical studyen
dc.subjectData baseen
dc.subjectElectronic medical recorden
dc.subjectHealth care qualityen
dc.subjectPatient informationen
dc.subjectRare canceren
dc.subjectRare cancersen
dc.subjectRare diseaseen
dc.subjectRare diseasesen
dc.subjectReimbursementen
dc.subjectResearch methodologyen
dc.subjectStudy designen
dc.titleRare Cancers Europe (RCE) methodological recommendations for clinical studies in rare cancers: A European consensus position paperen
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1093/annonc/mdu459
dc.description.volume26
dc.description.issue2
dc.description.startingpage300
dc.description.endingpage306
dc.author.facultyΙατρική Σχολή / Medical School
dc.type.uhtypeArticleen
dc.contributor.orcidPavlidis, Nicholas [0000-0002-2195-9961]
dc.contributor.orcidPentheroudakis, George [0000-0002-6632-2462]
dc.gnosis.orcid0000-0002-2195-9961
dc.gnosis.orcid0000-0002-6632-2462


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