title: Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations.
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).
  
  
  METHODS
  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.
  
  
  METHODS
  Current literature was reviewed for gaps in knowledge. Expert opinion was used to suggest studies required to address potential safety and efficacy issues.
  
  
  METHODS
  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.
authors.affiliation: Aarhus University Aarhus, Denmark.
authors.forename: Jens Sandahl
authors.initials: JS
authors.lastname: Christiansen
authors.affiliation: Cincinnati Children's Hospital Cincinnati, Ohio, USA.
authors.forename: Philippe F
authors.initials: PF
authors.lastname: Backeljauw
authors.affiliation: Klinikum der Universität München Munich, Germany.
authors.forename: Martin
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authors.affiliation: Massachusetts General Hospital Boston, Massachusetts, USA.
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authors.lastname: Biller
authors.affiliation: Federal University of Parana Curitiba, Brazil.
authors.forename: Margaret C S
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authors.lastname: Boguszewski
authors.affiliation: Santiago de Compostela University Santiago de Compostela, Spain.
authors.forename: Felipe F
authors.initials: FF
authors.lastname: Casanueva
authors.affiliation: Université Paris Saclay Le Kremlin-BicϪtre, France.
authors.forename: Philippe
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authors.lastname: Chanson
authors.affiliation: University Claude Bernard Lyon, France.
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authors.lastname: Chatelain
authors.affiliation: University of Western Australia Subiaco, Western Australia, Australia.
authors.forename: Catherine S
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authors.lastname: Choong
authors.affiliation: University of North Carolina Chapel Hill, North Carolina, USA.
authors.forename: David R
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authors.lastname: Clemmons
authors.affiliation: Boston Children's Hospital Boston, Massachusetts, USA.
authors.forename: Laurie E
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authors.lastname: Cohen
authors.affiliation: University of Southern California Los Angeles, California, USA.
authors.forename: Pinchas
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authors.lastname: Cohen
authors.affiliation: Aarhus University Aarhus, Denmark.
authors.forename: Jan
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authors.lastname: Frystyk
authors.affiliation: Children's Hospital of Philadelphia Philadelphia, Pennsylvania, USA.
authors.forename: Adda
authors.initials: A
authors.lastname: Grimberg
authors.affiliation: Tokyo Metropolitan Children's Medical Center Tokyo, Japan.
authors.forename: Yukihiro
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authors.lastname: Hasegawa
authors.affiliation: Baylor College of Medicine Houston, Texas, USA.
authors.forename: Morey W
authors.initials: MW
authors.lastname: Haymond
authors.affiliation: University of Queensland Brisbane, Queensland, Australia.
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authors.initials: AR
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authors.affiliation: University of Bristol Bristol, UK.
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authors.affiliation: National Center for Child Health and Development Tokyo, Japan.
authors.forename: Reiko
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authors.affiliation: Karolinska University Hospital Stockholm, Sweden.
authors.forename: Charlotte
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authors.lastname: Höybye
authors.affiliation: Aarhus University Aarhus, Denmark.
authors.forename: Jens Otto L
authors.initials: JO
authors.lastname: Jorgensen
authors.affiliation: University of Gothenburg Gothenburg, Sweden.
authors.forename: Gudmundur
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authors.lastname: Johannsson
authors.affiliation: Rigshospitalet University of Copenhagen, Copenhagen, Denmark.
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authors.lastname: Juul
authors.affiliation: Stanford University Stanford, California, USA.
authors.forename: Laurence
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authors.lastname: Katznelson
authors.affiliation: Ohio University Athens, Ohio, USA.
authors.forename: John J
authors.initials: JJ
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authors.affiliation: National University of Singapore Singapore, Singapore.
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authors.lastname: Lee
authors.affiliation: UCLA School of Medicine Los Angeles, California, USA.
authors.forename: Kuk-Wha
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authors.affiliation: Tongji Hospital Wuhan, China.
authors.forename: Xiaoping
authors.initials: X
authors.lastname: Luo
authors.affiliation: Cedars-Sinai Medical Center Los Angeles, California, USA.
authors.forename: Shlomo
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authors.lastname: Melmed
authors.affiliation: Masonic Children's Hospital Minneapolis, Minnesota, USA.
authors.forename: Bradley S
authors.initials: BS
authors.lastname: Miller
authors.affiliation: Massachusetts General Hospital Boston, Massachusetts, USA.
authors.forename: Madhusmita
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authors.lastname: Misra
authors.affiliation: University of Belgrade Belgrade, Serbia.
authors.forename: Vera
authors.initials: V
authors.lastname: Popovic
authors.affiliation: Stat5 Consulting Los Altos, California, USA.
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authors.initials: RG
authors.lastname: Rosenfeld
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authors.forename: Judith
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authors.lastname: Ross
authors.affiliation: University of Sheffield Sheffield, UK.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Ross
authors.affiliation: SUNY Stony Brook, New York, USA.
authors.forename: Paul
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authors.lastname: Saenger
authors.affiliation: Charite-Universitätsmedizin Berlin, Germany.
authors.forename: Christian J
authors.initials: CJ
authors.lastname: Strasburger
authors.affiliation: University of Virginia Charlottesville, Virginia, USA.
authors.forename: Michael O
authors.initials: MO
authors.lastname: Thorner
authors.affiliation: Tel Aviv University Tel Aviv, Israel.
authors.forename: Haim
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mesh_terms: D002986:Clinical Trials as Topic; D032921:Consensus; D004393:Dwarfism, Pituitary / Q000188:drug therapy*; D020249:Hormone Replacement Therapy / Q000009:adverse effects / Q000379:methods*; D019382:Human Growth Hormone / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D012107:Research Design
chemical_list: D019382:Human Growth Hormone