Kankerrisico van biologicals vaststellen? Beperkingen in bruikbaarheid van meta-analyse

TY - JOUR

T1 - Kankerrisico van biologicals vaststellen?

T2 - Beperkingen in bruikbaarheid van meta-analyse

AU - Vermeer, Niels S

AU - De Bruin, Marie L

PY - 2013

Y1 - 2013

N2 - Safety meta-analyses could play an important role in capturing fragmented safety data from underpowered clinical studies. Their utility, however, is hampered by the same constraints surrounding clinical studies, including limited external validity, inconsistent classification and the underreporting of safety data. When long-term adverse effects are studied, like the risk of malignancy associated with the use of inhibitors of tumour necrosis factor (TNF) alpha, particular scrutiny should be exercised in deciding whether the individual trials included have allowed sufficient follow-up time for the safety endpoint to occur.

AB - Safety meta-analyses could play an important role in capturing fragmented safety data from underpowered clinical studies. Their utility, however, is hampered by the same constraints surrounding clinical studies, including limited external validity, inconsistent classification and the underreporting of safety data. When long-term adverse effects are studied, like the risk of malignancy associated with the use of inhibitors of tumour necrosis factor (TNF) alpha, particular scrutiny should be exercised in deciding whether the individual trials included have allowed sufficient follow-up time for the safety endpoint to occur.

KW - Adverse Drug Reaction Reporting Systems

KW - Biological Therapy

KW - Humans

KW - Meta-Analysis as Topic

KW - Neoplasms

KW - Reproducibility of Results

KW - English Abstract

KW - Journal Article

M3 - Tidsskriftartikel

C2 - 23388143

SN - 0028-2162

VL - 157

SP - A5884

JO - Nederlands Tijdschrift voor Geneeskunde

JF - Nederlands Tijdschrift voor Geneeskunde

IS - 6

ER -