Skip to main navigation menu Skip to main content Skip to site footer

Technical comment

Vol. 150 No. 2122 (2020)

Comment on: Mumme M, et al. Tissue engineering for paediatric patients. Swiss Med Wkly. 2019.149.w20032

  • Klaus Rose
  • Jane M. Grant-Kels
  • David Neubauer
  • Lucio Fumi
Cite this as:
Swiss Med Wkly. 2020;150:w20239


  1. Mumme M, Wixmerten A, Miot S, Barbero A, Kaempfen A, Saxer F, et al. Tissue engineering for paediatric patients. Swiss Med Wkly. 2019;149:w20032. Available at:
  2. Rose K. The Challenges of Pediatric Drug Development. Curr Ther Res Clin Exp. 2019;90:128–34. doi:.
  3. Rose K, Grant-Kels JM. The Meanings of “Pediatric Drug Development”. Ther Innov Regul Sci. 2019;53(6):767–74. doi:.
  4. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Committee on Drugs, American Academy of Pediatrics. Pediatrics. 1995;95(2):286–94. Available at:
  5. Rose K, Neubauer D, Grant-Kels JM. Rational Use of Medicine in Children-The Conflict of Interests Story. A Review. Rambam Maimonides Med J. 2019;10(3):e0018. doi:.
  6. Ward RM, Benjamin DK, Jr, Davis JM, Gorman RL, Kauffman R, Kearns GL, et al. The Need for Pediatric Drug Development. J Pediatr. 2018;192:13–21. doi:.
  7. Norris RE, Adamson PC. Challenges and opportunities in childhood cancer drug development. Nat Rev Cancer. 2012;12(11):776–82. doi:.
  8. Waubant E, Banwell B, Wassmer E, Sormani MP, Amato MP, Hintzen R, et al.; IPMSSG. Clinical trials of disease-modifying agents in pediatric MS: Opportunities, challenges, and recommendations from the IPMSSG. Neurology. 2019;92(22):e2538–49. doi:.
  9. Rose K, Neubauer D, Grant-Kels JM. Too Many Avoidable Suicides Occur Worldwide In Young Patients. A Review. Rambam Maimonides Med J. 2019, Sep 18.
  10. Rose K, Kopp MV. Pediatric investigation plans for specific immunotherapy: Questionable contributions to childhood health. Pediatr Allergy Immunol. 2015;26(8):695–701. doi:.
  11. PIP EMEA-001264-PIP01-12-M02
  12. PIP EMEA-000736-PIP01-09
  13. PIP EMEA-000979-PIP01-10-M02
  14. PIP EMEA-001823-PIP01-15-M01
  15. PIP EMEA-002217-PIP01-17
  16. Gudas R, Gudaite A, Pocius A, Gudiene A, Cekanauskas E, Monastyreckiene E, et al. Ten-year follow-up of a prospective, randomized clinical study of mosaic osteochondral autologous transplantation versus microfracture for the treatment of osteochondral defects in the knee joint of athletes. Am J Sports Med. 2012;40(11):2499–508. doi:.
  17. Maude SL, Laetsch TW, Buechner J, Rives S, Boyer M, Bittencourt H, et al. Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia. N Engl J Med. 2018;378(5):439–48. doi:.
  18. Plate V. The Impact of Off-Label, Compassionate and Unlicensed Use on Health Care Laws in preselected Countries [dissertation]. Bonn: Rheinischen Friedrich-Wilhelms-Universität; 2009.
  19. Janssen WM. A Historical Perspective on Off-Label Medicine: From Regulation, Promotion, and the First Amendment to the Next Frontiers. Food and Drug Law Institute, Levy MC (Editor). First Washington, D.C., USA: Off-Label Communications; 2008
  20. Rose K, Grant-Kels JM. Pediatric melanoma-The whole (conflicts of interest) story. Int J Womens Dermatol. 2019;5(2):110–5. Available at: doi:.
  21. EMA. 2004. Evidence of harm from off-label or unlicensed medicines in children.
  22. Tomasi PA, Egger GF, Pallidis C, Saint-Raymond A. Enabling Development of Paediatric Medicines in Europe: 10 Years of the EU Paediatric Regulation. Paediatr Drugs. 2017;19(6):505–13. doi:.
  23. Bucci-Rechtweg C. Enhancing the pediatric drug development framework to deliver better pediatric therapies tomorrow. Clin Ther. 2017;39(10):1920–32. doi:.
  24. EDSPPP 2019
  25. Rose K, Grant-Kels JM. Questionable International Pediatric Studies With Swiss Participation. Swiss Med Wkly. 2018. Available at: