TY - JOUR
T1 - Publication rates and reported results in a cohort of gene-and cell-based therapy trials
AU - Coppens, Delphi G.M.
AU - Gardarsdottir, Helga
AU - Van Den Bogert, Cornelis A.
AU - De Bruin, Marie L.
AU - Leufkens, Hubert G.M.
AU - Hoekman, Jarno
PY - 2020
Y1 - 2020
N2 - Aim: We investigated publication rates and reported results for gene-and cell-based therapy trials. Materials & methods: In a cohort of Institutional Review Board (IRB)-authorized trials during 2007-2017 in the Netherlands (n = 105), we examine publication rates and reported results in scientific papers and conference abstracts as well as associations with the occurrence of trial characteristics. Results: The publication rate for scientific papers was 27% and 17% for conference abstracts (median survival time: 1050 days). Academic hospitals published more in scientific papers whereas private sponsors published more in conference abstracts. Manufacturing protocols were underreported compared with clinical outcomes. Most publications reported positive results (78%). Conclusion: Publication rates are currently suboptimal indicating a need for enhanced knowledge sharing to stimulate gene-and cell-based therapy development.
AB - Aim: We investigated publication rates and reported results for gene-and cell-based therapy trials. Materials & methods: In a cohort of Institutional Review Board (IRB)-authorized trials during 2007-2017 in the Netherlands (n = 105), we examine publication rates and reported results in scientific papers and conference abstracts as well as associations with the occurrence of trial characteristics. Results: The publication rate for scientific papers was 27% and 17% for conference abstracts (median survival time: 1050 days). Academic hospitals published more in scientific papers whereas private sponsors published more in conference abstracts. Manufacturing protocols were underreported compared with clinical outcomes. Most publications reported positive results (78%). Conclusion: Publication rates are currently suboptimal indicating a need for enhanced knowledge sharing to stimulate gene-and cell-based therapy development.
KW - academic research
KW - clinical trial cohort
KW - clinical trial transparency
KW - commercial development
KW - conference abstract
KW - drug regulatory science
KW - gene-and cell-based therapies
KW - publication bias
KW - scientific publication
U2 - 10.2217/rme-2019-0066
DO - 10.2217/rme-2019-0066
M3 - Journal article
C2 - 32103712
AN - SCOPUS:85082145335
SN - 1746-0751
VL - 15
SP - 1215
EP - 1227
JO - Regenerative Medicine
JF - Regenerative Medicine
IS - 1
ER -