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, Hoeybye, Charlotte, Jorgensen, Jens Otto L., 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 and Yuen, Kevin (2016) Growth hormone research society perspective on the development of long-acting growth hormone preparations. European Journal of Endocrinology, 174 6: C1-C8. doi:10.1530/EJE-16-0111

Author 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
Hoeybye, Charlotte
Jorgensen, Jens Otto L.
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
Title Growth hormone research society perspective on the development of long-acting growth hormone preparations
Journal name European Journal of Endocrinology   Check publisher's open access policy
ISSN 0804-4643
Publication date 2016-06-01
Sub-type Letter to editor, brief commentary or brief communication
DOI 10.1530/EJE-16-0111
Open Access Status DOI
Volume 174
Issue 6
Start page C1
End page C8
Total pages 8
Place of publication Bristol, United Kingdom
Publisher BioScientifica
Language eng
Formatted abstract
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
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Letter to editor, brief commentary or brief communication
Collections: HERDC Pre-Audit
School of Medicine Publications
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