Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations. / Christiansen, Jens Sandahl; Backeljauw, Philippe F; Bidlingmaier, Martin; Biller, Beverly M K; Boguszewski, Margaret C S; Casanueva, Felipe F; Chanson, Philippe; Chatelain, Pierre; Choong, Catherine S; Clemmons, David R; Cohen, Laurie E; Cohen, Pinchas; Frystyk, Jan; Grimberg, Adda; Hasegawa, Yukihiro; Haymond, Morey W; Ho, Ken; Hoffman, Andrew R; Holly, Jeff M P; Horikawa, Reiko; Höybye, Charlotte; Jorgensen, Jens Otto Lunde; Johannsson, Gudmundur; Juul, Anders; Katznelson, Laurence; Kopchick, John J.; Lee, K O; Lee, Kuk-Wha; Luo, Xiaoping; Melmed, Shlomo; Miller, Bradley S; Misra, Madhusmita; Popovic, Vera; Rosenfeld, Ron G; Ross, Judith; Ross, Richard J; Saenger, Paul; Strasburger, Christian J; Thorner, Michael O; Werner, Haim; Yuen, Kevin C J.
I: European Journal of Endocrinology, Bind 174, Nr. 6, 06.2016, s. C1-8.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations
AU - Christiansen, Jens Sandahl
AU - Backeljauw, Philippe F
AU - Bidlingmaier, Martin
AU - Biller, Beverly M K
AU - Boguszewski, Margaret C S
AU - Casanueva, Felipe F
AU - Chanson, Philippe
AU - Chatelain, Pierre
AU - Choong, Catherine S
AU - Clemmons, David R
AU - Cohen, Laurie E
AU - Cohen, Pinchas
AU - Frystyk, Jan
AU - Grimberg, Adda
AU - Hasegawa, Yukihiro
AU - Haymond, Morey W
AU - Ho, Ken
AU - Hoffman, Andrew R
AU - Holly, Jeff M P
AU - Horikawa, Reiko
AU - Höybye, Charlotte
AU - Jorgensen, Jens Otto Lunde
AU - Johannsson, Gudmundur
AU - Juul, Anders
AU - Katznelson, Laurence
AU - Kopchick, John J.
AU - Lee, K O
AU - Lee, Kuk-Wha
AU - Luo, Xiaoping
AU - Melmed, Shlomo
AU - Miller, Bradley S
AU - Misra, Madhusmita
AU - Popovic, Vera
AU - Rosenfeld, Ron G
AU - Ross, Judith
AU - Ross, Richard J
AU - Saenger, Paul
AU - Strasburger, Christian J
AU - Thorner, Michael O
AU - Werner, Haim
AU - Yuen, Kevin C J
N1 - © 2016 The authors.
PY - 2016/6
Y1 - 2016/6
N2 - OBJECTIVE: The Growth Hormone (GH) Research Society (GRS) convened a workshop to address important issues regarding trial design, efficacy, and safety of long-acting growth hormone preparations (LAGH).PARTICIPANTS: A closed meeting of 55 international scientists with expertise in GH, including pediatric and adult endocrinologists, basic scientists, regulatory scientists, and participants from the pharmaceutical industry.EVIDENCE: Current literature was reviewed for gaps in knowledge. Expert opinion was used to suggest studies required to address potential safety and efficacy issues.CONSENSUS PROCESS: Following plenary presentations summarizing the literature, breakout groups discussed questions framed by the planning committee. Attendees reconvened after each breakout session to share group reports. A writing team compiled the breakout session reports into a draft document that was discussed and revised in an open forum on the concluding day. This was edited further and then circulated to attendees from academic institutions for review after the meeting. Participants from pharmaceutical companies did not participate in the planning, writing, or in the discussions and text revision on the final day of the workshop. Scientists from industry and regulatory agencies reviewed the manuscript to identify any factual errors.CONCLUSIONS: LAGH compounds may represent an advance over daily GH injections because of increased convenience and differing phamacodynamic properties, providing the potential for improved adherence and outcomes. Better methods to assess adherence must be developed and validated. Long-term surveillance registries that include assessment of efficacy, cost-benefit, disease burden, quality of life, and safety are essential for understanding the impact of sustained exposure to LAGH preparations.
AB - OBJECTIVE: The Growth Hormone (GH) Research Society (GRS) convened a workshop to address important issues regarding trial design, efficacy, and safety of long-acting growth hormone preparations (LAGH).PARTICIPANTS: A closed meeting of 55 international scientists with expertise in GH, including pediatric and adult endocrinologists, basic scientists, regulatory scientists, and participants from the pharmaceutical industry.EVIDENCE: Current literature was reviewed for gaps in knowledge. Expert opinion was used to suggest studies required to address potential safety and efficacy issues.CONSENSUS PROCESS: Following plenary presentations summarizing the literature, breakout groups discussed questions framed by the planning committee. Attendees reconvened after each breakout session to share group reports. A writing team compiled the breakout session reports into a draft document that was discussed and revised in an open forum on the concluding day. This was edited further and then circulated to attendees from academic institutions for review after the meeting. Participants from pharmaceutical companies did not participate in the planning, writing, or in the discussions and text revision on the final day of the workshop. Scientists from industry and regulatory agencies reviewed the manuscript to identify any factual errors.CONCLUSIONS: LAGH compounds may represent an advance over daily GH injections because of increased convenience and differing phamacodynamic properties, providing the potential for improved adherence and outcomes. Better methods to assess adherence must be developed and validated. Long-term surveillance registries that include assessment of efficacy, cost-benefit, disease burden, quality of life, and safety are essential for understanding the impact of sustained exposure to LAGH preparations.
KW - Clinical Trials as Topic
KW - Consensus
KW - Dwarfism, Pituitary
KW - Hormone Replacement Therapy
KW - Human Growth Hormone
KW - Humans
KW - Research Design
KW - Journal Article
U2 - 10.1530/EJE-16-0111
DO - 10.1530/EJE-16-0111
M3 - Journal article
C2 - 27009113
VL - 174
SP - C1-8
JO - European Journal of Endocrinology
JF - European Journal of Endocrinology
SN - 0804-4643
IS - 6
ER -
ID: 176612663