Complying with the European Clinical Trials directive while surviving the administrative pressure - An alternative approach to toxicity registration in a cancer trial

European Journal of Cancer

Volumn 50, Issue 2, 2014, Pages 251-259

  Frandsen, Thomas Leth ^a   Heyman, Mats ^b   Abrahamsson, Jonas ^c   Vettenranta, Kim ^d   Åsberg, Ann ^e   Vaitkeviciene, Goda ^f   Pruunsild, Kaie ^g   Toft, Nina ^h   Birgens, Henrik ^h   Hallböök, Helena ⁱ   Quist Paulsen, Petter ^j   Griškevičius, Laimonas ^k   Helt, Louise ^a   Hansen, Birgitte Vilsbøll ^l   Schmiegelow, Kjeld ^a,m  

^a Rigshospitalet   (Denmark)

^b KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^c SAHLGRENSKA ACADEMY AT UNIVERSITY OF GOTHENBURG   (Sweden)

^d TAMPERE UNIVERSITY OF TECHNOLOGY   (Finland)

^e TRONDHEIM UNIVERSITY HOSPITAL   (Norway)

^f Centre for Paediatric Oncology and Haematology   (Lithuania)

^g TALLINN CHILDREN S HOSPITAL   (Estonia)

^h Mental Health Services CPH   (Denmark)

ⁱ UPPSALA UNIVERSITY HOSPITAL   (Sweden)

^j NORWEGIAN UNIVERSITY OF SCIENCE AND TECHNOLOGY   (Norway)

^k VILNIUS UNIVERSITY   (Lithuania)

^l UNIVERSITY OF COPENHAGEN   (Denmark)

^m UNIVERSITY OF COPENHAGEN   (Denmark)

more..

Author keywords

Acute lymphoblastic leukaemia; Chemotherapy; Children; Clinical trial; Registration; Toxicity

Indexed keywords

ASPARAGINE; CYTARABINE; MERCAPTOPURINE; METHOTREXATE; PREDNISOLONE;

ALLERGIC REACTION; ARTICLE; BONE NECROSIS; CHOLECYSTITIS; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); COLON PERFORATION; DRUG SAFETY; GOOD CLINICAL PRACTICE; HIGH RISK PATIENT; HUMAN; HYPERLIPIDEMIA; HYPOGLYCEMIA; MORTALITY; MYCOSIS; PANCREATITIS; PATIENT MONITORING; PRIORITY JOURNAL; PROTOCOL COMPLIANCE; REGISTER; REGISTRATION; RISK ASSESSMENT; THROMBOSIS; TOXIC EPIDERMAL NECROLYSIS; TOXICITY; TOXICITY REGISTRATION;

EID: 84891835299     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2013.09.027     Document Type: Article

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