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@ARTICLE{Dhaenens:277314,
      author       = {B. A. E. Dhaenens and F. Mahler and H. Batchelor and P.
                      Dicks and S. Gaillard and B. Nafria and A.
                      Kopp-Schneider$^*$ and M. A. Ribeiro and M. Schwab and M.
                      Sparber-Sauer and J. Leubner and S. N. de Wildt and R.
                      Oostenbrink},
      title        = {{O}ptimizing expert and patient input in pediatric trial
                      design: {L}essons learned and recommendations from a
                      collaboration between conect4children and {E}uropean
                      {P}atient-{CE}ntric {C}linic{A}l {TR}ial {PL}atforms.},
      journal      = {Clinical and translational science},
      volume       = {16},
      number       = {8},
      issn         = {1752-8054},
      address      = {Oxford},
      publisher    = {Blackwell [[-2008]]},
      reportid     = {DKFZ-2023-01332},
      pages        = {1458-1468},
      year         = {2023},
      note         = {2023 Aug;16(8):1458-1468},
      abstract     = {Advice from multiple stakeholders is required to design the
                      optimal pediatric clinical trial. We present recommendations
                      for acquiring advice from trial experts and
                      patients/caregivers, derived from advice meetings that were
                      performed through a collaboration of the Collaborative
                      Network for European Clinical Trials for Children (c4c) and
                      the European Patient-CEntric ClinicAl TRial PLatforms
                      (EU-PEARL). Three advice meetings were performed: (1) an
                      advice meeting for clinical and methodology experts, (2) an
                      advice meeting for patients/caregivers, and (3) a combined
                      meeting with both experts and patients/caregivers. Trial
                      experts were recruited from c4c database.
                      Patients/caregivers were recruited through a patient
                      organization. Participants were asked to provide input on a
                      trial protocol, including endpoints, outcomes, and the
                      assessment schedule. Ten experts, 10 patients, and 13
                      caregivers participated. The advice meetings resulted in
                      modification of eligibility criteria and outcome measures.
                      We have provided recommendations for the most effective
                      meeting type per protocol topic. Topics with limited options
                      for patient input were most efficiently discussed in expert
                      advice meetings. Other topics benefit from patient/caregiver
                      input, either through a combined meeting with experts or a
                      patients/caregivers-only advice meeting. Some topics, such
                      as endpoints and outcome measures, are suitable for all
                      meeting types. Combined sessions profit from synergy between
                      experts and patients/caregivers, balancing input on protocol
                      scientific feasibility and acceptability. Both experts and
                      patients/caregivers provided critical input on the presented
                      protocol. The combined meeting was the most effective
                      methodology for most protocol topics. The presented
                      methodology can be used effectively to acquire expert and
                      patient feedback.},
      cin          = {C060},
      ddc          = {610},
      cid          = {I:(DE-He78)C060-20160331},
      pnm          = {313 - Krebsrisikofaktoren und Prävention (POF4-313)},
      pid          = {G:(DE-HGF)POF4-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:37391924},
      doi          = {10.1111/cts.13547},
      url          = {https://inrepo02.dkfz.de/record/277314},
}