Reducing Bureaucracy in Clinical Research: A Call for Action
dc.contributor.author | Gribben, J | |
dc.contributor.author | Macintyre, E | |
dc.contributor.author | Sonneveld, P | |
dc.contributor.author | Doorduijn, J | |
dc.contributor.author | Gisselbrecht, C | |
dc.contributor.author | Jäger, U | |
dc.contributor.author | Le Gouill, S | |
dc.contributor.author | Rule, Simon | |
dc.contributor.author | Dreyling, M | |
dc.date.accessioned | 2022-03-04T09:59:53Z | |
dc.date.available | 2022-03-04T09:59:53Z | |
dc.date.issued | 2020-01-01 | |
dc.identifier.issn | 2572-9241 | |
dc.identifier.issn | 2572-9241 | |
dc.identifier.other | ARTN e352 | |
dc.identifier.uri | http://hdl.handle.net/10026.1/18879 | |
dc.description.abstract |
The increasing administrative burden associated with conducting clinical trials is a threat to patient safety, independent academic clinical research, and access to affordable innovation. While the Clinical Trials Regulation1 —adopted by the European Parliament in 2014 to replace the Clinical Trials Directive2 (from 2001) and finally expected to become applicable in the course of 2020—will go some way in addressing bureaucracy overload, more action is needed. This article discusses the issues resulting from the exponential growth of regulatory and administrative requirements for the conduct of clinical studies and the impact this is having on researchers and patients. It also describes how the European Hematology Association (EHA) is coordinating a series of activities to advance potential solutions for these issues. | |
dc.format.extent | e352-e352 | |
dc.format.medium | Electronic-eCollection | |
dc.language | en | |
dc.language.iso | en | |
dc.publisher | Lippincott, Williams & Wilkins | |
dc.title | Reducing Bureaucracy in Clinical Research: A Call for Action | |
dc.type | journal-article | |
dc.type | Editorial | |
plymouth.author-url | https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000555309800011&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008 | |
plymouth.issue | 2 | |
plymouth.volume | 4 | |
plymouth.publication-status | Published online | |
plymouth.journal | HemaSphere | |
dc.identifier.doi | 10.1097/hs9.0000000000000352 | |
plymouth.organisational-group | /Plymouth | |
plymouth.organisational-group | /Plymouth/Faculty of Health | |
plymouth.organisational-group | /Plymouth/Faculty of Health/Peninsula Medical School | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine/UoA01 Clinical Medicine | |
plymouth.organisational-group | /Plymouth/Research Groups | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED) | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CBR | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CCT&PS | |
plymouth.organisational-group | /Plymouth/Users by role | |
plymouth.organisational-group | /Plymouth/Users by role/Academics | |
dc.publisher.place | United States | |
dcterms.dateAccepted | 2020-01-01 | |
dc.rights.embargodate | 2022-3-9 | |
dc.identifier.eissn | 2572-9241 | |
dc.rights.embargoperiod | Not known | |
rioxxterms.versionofrecord | 10.1097/hs9.0000000000000352 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2020-01-01 | |
rioxxterms.type | Journal Article/Review |