Format

Send to

Choose Destination
See comment in PubMed Commons below
Eur J Cancer. 2014 Jan;50(2):251-9. doi: 10.1016/j.ejca.2013.09.027. Epub 2013 Nov 11.

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

Author information

1
Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark. Electronic address: thomas.leth.frandsen@regionh.dk.
2
Department of Paediatrics, University Hospitals, Astrid Lindgrens Barnsjukhus, Stockholm, Sweden.
3
Institution of Clinical Sciences, Department of Paediatrics, Queen Silvias Childrens Hospital, Gothenburg, Sweden.
4
Department of Paediatrics, University of Tampere, Finland.
5
Department of Paediatrics, University Hospital of Trondheim, Norway.
6
Centre for Paediatric Oncology and Haematology, University Children's Hospital, Vilnius, Lithuania.
7
Tallinn Children's Hospital, Tallinn, Estonia.
8
Department of Haematology, Copenhagen University Hospital, Herlev, Denmark.
9
Department of Hematology, Uppsala University Hospital, Uppsala, Sweden.
10
Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.
11
Department of Intensive Chemotherapy and Bone Marrow Transplantation, Vilnius University Hospital, Vilnius, Lithuania.
12
Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark.
13
Copenhagen University, GCP Unit, University Hospital of Copenhagen, Bispebjerg, Copenhagen N, Denmark.
14
Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark; Institute of Gynaecology, Obstetrics and Paediatrics, Faculty of Medicine, University of Copenhagen, Denmark. Electronic address: kjeld.schmiegelow@regionh.dk.

Abstract

The European Clinical Trials Directive of 2004 has increased the amount of paper work and reduced the number of initiated clinical trials. Particularly multinational trials have been delayed. To meet this challenge we developed a novel, simplified, fast and easy strategy for on-line toxicity registration for patients treated according to the Nordic/Baltic acute lymphoblastic leukaemia protocol, NOPHO ALL 2008, for children and young adults, including three randomisations. We used a risk-assessment based approach, avoiding reporting of expected adverse events and instead concentrating on 20 well-known serious, but rarer events with focus on changes in therapy introduced in the treatment protocol. This toxicity registration strategy was approved by the relevant regulatory authorities in all seven countries involved, as compliant within the EU directive of 2004. The centre compliance to registration was excellent with 98.9% of all patients being registered within 5weeks from the requested quarterly registration. Currently, four toxicities (thrombosis, fungal infections, pancreatitis and allergic reactions) have been chosen for further detailed exploration due to the cumulative fraction of patients with positive registrations exceeding 5%. This toxicity registration offers real-time toxicity profiles of the total study cohort and provides early warnings of specific toxicities that require further investigation.

KEYWORDS:

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

PMID:
24231337
DOI:
10.1016/j.ejca.2013.09.027
[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Elsevier Science
    Loading ...
    Support Center