dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Garralda Cabanas, Elena |
dc.contributor.author | Piris Giménez, Alejandro |
dc.contributor.author | Braña Garcia, Irene |
dc.contributor.author | Rodon Ahnert, Jordi |
dc.contributor.author | Tabernero Caturla, Josep |
dc.contributor.author | Dienstmann, Rodrigo |
dc.date.accessioned | 2019-02-19T08:49:26Z |
dc.date.available | 2019-02-19T08:49:26Z |
dc.date.issued | 2019-01-30 |
dc.identifier.citation | Garralda E, Dienstmann R, Piris A, Braña I, Rodon J, Tabernero J. New clinical trial designs in the era of Precision Medicine. Mol Oncol. 2019. |
dc.identifier.issn | 1878-0261 |
dc.identifier.uri | https://hdl.handle.net/11351/3791 |
dc.description | Adaptive designs; Umbrella protocols; Basket protocols |
dc.description.abstract | Cancer treatment has made significant strides towards the promise of personalized medicine. Recent scientific advances have shown that there are numerous genetic deregulations that are common in multiple cancer types, raising the possibility of developing drugs targeting those deregulations irrespective of the tumour type. Precision cancer medicine was born out of accumulated evidence matching targeted agents with these tumour molecular deregulations. At the same time, the therapeutic armamentarium is rapidly increasing and the number of new drugs (including immune-oncology agents) entering drug development continues to rise. These factors, added to strong collaboration with regulatory agencies which have approved novel agents based on data obtained from Phase 1/2 trials, have led to unprecedented evolution in the design of early stage clinical trials. Currently, we have seen rapid Phase 1 dose escalation trials followed by remarkably large expansion cohorts, and are witnessing the emergence of new trials, such as adaptive studies with basket and umbrella designs aimed at optimizing the biomarker-drug co-development process. Alongside the growing complexity of these clinical trials, new frameworks for stronger and faster collaboration between all stakeholders in drug development, including academic institutions and frameworks, clinicians, pharma companies and regulatory agencies, have been established. In this review article, we describe the main challenges and opportunities that these new trial designs may provide for a more efficient drug development process, which may ultimately help ensure that precision cancer medicine becomes a reality for patients |
dc.language.iso | eng |
dc.publisher | Wiley Open Access |
dc.relation.ispartofseries | Molecular Oncology; |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ |
dc.source | Scientia |
dc.subject | Medicina personalitzada |
dc.subject | Assaigs clínics |
dc.subject | Oncologia |
dc.subject.mesh | Clinical Trials as Topic |
dc.subject.mesh | Precision Medicine |
dc.subject.mesh | Medical Oncology |
dc.title | New clinical trial designs in the era of Precision Medicine |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1002/1878-0261.12465 |
dc.subject.decs | ensayos clínicos como asunto |
dc.subject.decs | medicina de precisión |
dc.subject.decs | oncología médica |
dc.relation.publishversion | https://febs.onlinelibrary.wiley.com/doi/abs/10.1002/1878-0261.12465 |
dc.type.version | info:eu-repo/semantics/acceptedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut Català de la Salut |
dc.contributor.authoraffiliation | [Garralda E] Servei d'oncologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain. Vall d'Hebron Institut d'Oncologia, Barcelona, Spain. Grup de Desenvolupament Clínic Precoç de Fàrmacs, Vall d'Hebron Institut d'Oncologia, Barcelona, Spain. [Dienstmann R] Servei d'oncologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain. Vall d'Hebron Institut d'Oncologia, Barcelona, Spain. Grup d’Oncology Data Science (ODysSey), Vall d'Hebron Institut d'Oncologia, Barcelona, Spain. [Piris A, Brana I] Servei d'oncologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain. Vall d'Hebron Institut d'Oncologia, Barcelona, Spain. [Rodon J] Servei d'oncologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain. Vall d'Hebron Institut d'Oncologia, Barcelona, Spain. MD Anderson Cancer Center, Houston, United States. [Tabernero J] Servei d'oncologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain. Vall d'Hebron Institut d'Oncologia, Barcelona, Spain. |
dc.identifier.pmid | 30698321 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |