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September 21, 2020 article Open access Aachen paper

Development of Novel, Value-Based, Digital Endpoints for Clinical Trials: A Structured Approach Toward Fit-for-Purpose Validation

Pharmacological Reviews, vol. 72, pp. 899–909

DOI: 10.1124/pr.120.000028 Full text (OA) OpenAlex

Authors 8

  1. Matthijs D. Kruizinga Aachen Centre for Human Drug Research (CHDR)

    Leiden University Medical Center · Critical Path Institute · Centre for Human Drug Research · Haga Hospital · Juliana Kinderziekenhuis

    Affiliation as printed

    Centre for Human Drug Research, Leiden, The Netherlands (M.D.K., F.E.S., V.E., R.J.D., G.J.G., A.F.C.); Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands (M.D.K., G.J.A.D.); Leiden University Medical Center, Leiden, The Netherlands (M.D.K., F.E.S., G.J.G., A.F.C.); and Critical Path for Parkinson's Consortium, Critical Path Institute, Tucson, Arizona (D.T.S.)

    Centre for Human Drug Research, Leiden, The Netherlands (M.D.K., F.E.S., V.E., R.J.D., G.J.G., A.F.C.)

    Critical Path for Parkinson's Consortium, Critical Path Institute, Tucson, Arizona (D.T.S.)

    Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands (M.D.K., G.J.A.D.)

    Leiden University Medical Center, Leiden, The Netherlands (M.D.K., F.E.S., G.J.G., A.F.C.)

  2. Frederik E. Stuurman Aachen Centre for Human Drug Research (CHDR)

    Leiden University Medical Center · Critical Path Institute · Centre for Human Drug Research · Haga Hospital · Juliana Kinderziekenhuis

    Affiliation as printed

    Centre for Human Drug Research, Leiden, The Netherlands (M.D.K., F.E.S., V.E., R.J.D., G.J.G., A.F.C.); Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands (M.D.K., G.J.A.D.); Leiden University Medical Center, Leiden, The Netherlands (M.D.K., F.E.S., G.J.G., A.F.C.); and Critical Path for Parkinson's Consortium, Critical Path Institute, Tucson, Arizona (D.T.S.)

    Centre for Human Drug Research, Leiden, The Netherlands (M.D.K., F.E.S., V.E., R.J.D., G.J.G., A.F.C.)

    Critical Path for Parkinson's Consortium, Critical Path Institute, Tucson, Arizona (D.T.S.)

    Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands (M.D.K., G.J.A.D.)

    Leiden University Medical Center, Leiden, The Netherlands (M.D.K., F.E.S., G.J.G., A.F.C.)

  3. Vasileios Exadaktylos Aachen Centre for Human Drug Research (CHDR)

    Leiden University Medical Center · Critical Path Institute · Centre for Human Drug Research · Haga Hospital · Juliana Kinderziekenhuis

    Affiliation as printed

    Centre for Human Drug Research, Leiden, The Netherlands (M.D.K., F.E.S., V.E., R.J.D., G.J.G., A.F.C.); Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands (M.D.K., G.J.A.D.); Leiden University Medical Center, Leiden, The Netherlands (M.D.K., F.E.S., G.J.G., A.F.C.); and Critical Path for Parkinson's Consortium, Critical Path Institute, Tucson, Arizona (D.T.S.)

    Centre for Human Drug Research, Leiden, The Netherlands (M.D.K., F.E.S., V.E., R.J.D., G.J.G., A.F.C.)

    Critical Path for Parkinson's Consortium, Critical Path Institute, Tucson, Arizona (D.T.S.)

    Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands (M.D.K., G.J.A.D.)

    Leiden University Medical Center, Leiden, The Netherlands (M.D.K., F.E.S., G.J.G., A.F.C.)

  4. Robert Jan Doll Aachen Centre for Human Drug Research (CHDR)

    Leiden University Medical Center · Critical Path Institute · Centre for Human Drug Research · Haga Hospital · Juliana Kinderziekenhuis

    Affiliation as printed

    Centre for Human Drug Research, Leiden, The Netherlands (M.D.K., F.E.S., V.E., R.J.D., G.J.G., A.F.C.); Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands (M.D.K., G.J.A.D.); Leiden University Medical Center, Leiden, The Netherlands (M.D.K., F.E.S., G.J.G., A.F.C.); and Critical Path for Parkinson's Consortium, Critical Path Institute, Tucson, Arizona (D.T.S.)

    Centre for Human Drug Research, Leiden, The Netherlands (M.D.K., F.E.S., V.E., R.J.D., G.J.G., A.F.C.)

    Critical Path for Parkinson's Consortium, Critical Path Institute, Tucson, Arizona (D.T.S.)

    Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands (M.D.K., G.J.A.D.)

    Leiden University Medical Center, Leiden, The Netherlands (M.D.K., F.E.S., G.J.G., A.F.C.)

  5. Diane T. Stephenson Aachen Centre for Human Drug Research (CHDR)

    Leiden University Medical Center · Critical Path Institute · Centre for Human Drug Research · Haga Hospital · Juliana Kinderziekenhuis

    Affiliation as printed

    Centre for Human Drug Research, Leiden, The Netherlands (M.D.K., F.E.S., V.E., R.J.D., G.J.G., A.F.C.); Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands (M.D.K., G.J.A.D.); Leiden University Medical Center, Leiden, The Netherlands (M.D.K., F.E.S., G.J.G., A.F.C.); and Critical Path for Parkinson's Consortium, Critical Path Institute, Tucson, Arizona (D.T.S.)

    Centre for Human Drug Research, Leiden, The Netherlands (M.D.K., F.E.S., V.E., R.J.D., G.J.G., A.F.C.)

    Critical Path for Parkinson's Consortium, Critical Path Institute, Tucson, Arizona (D.T.S.)

    Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands (M.D.K., G.J.A.D.)

    Leiden University Medical Center, Leiden, The Netherlands (M.D.K., F.E.S., G.J.G., A.F.C.)

  6. Geert Jan Groeneveld Aachen Centre for Human Drug Research (CHDR)

    Leiden University Medical Center · Critical Path Institute · Centre for Human Drug Research · Haga Hospital · Juliana Kinderziekenhuis

    Affiliation as printed

    Centre for Human Drug Research, Leiden, The Netherlands (M.D.K., F.E.S., V.E., R.J.D., G.J.G., A.F.C.); Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands (M.D.K., G.J.A.D.); Leiden University Medical Center, Leiden, The Netherlands (M.D.K., F.E.S., G.J.G., A.F.C.); and Critical Path for Parkinson's Consortium, Critical Path Institute, Tucson, Arizona (D.T.S.)

    Centre for Human Drug Research, Leiden, The Netherlands (M.D.K., F.E.S., V.E., R.J.D., G.J.G., A.F.C.)

    Critical Path for Parkinson's Consortium, Critical Path Institute, Tucson, Arizona (D.T.S.)

    Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands (M.D.K., G.J.A.D.)

    Leiden University Medical Center, Leiden, The Netherlands (M.D.K., F.E.S., G.J.G., A.F.C.)

  7. Gertjan J. A. Driessen Aachen Centre for Human Drug Research (CHDR)

    Leiden University Medical Center · Critical Path Institute · Centre for Human Drug Research · Haga Hospital · Juliana Kinderziekenhuis

    Affiliation as printed

    Centre for Human Drug Research, Leiden, The Netherlands (M.D.K., F.E.S., V.E., R.J.D., G.J.G., A.F.C.); Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands (M.D.K., G.J.A.D.); Leiden University Medical Center, Leiden, The Netherlands (M.D.K., F.E.S., G.J.G., A.F.C.); and Critical Path for Parkinson's Consortium, Critical Path Institute, Tucson, Arizona (D.T.S.)

    Centre for Human Drug Research, Leiden, The Netherlands (M.D.K., F.E.S., V.E., R.J.D., G.J.G., A.F.C.)

    Critical Path for Parkinson's Consortium, Critical Path Institute, Tucson, Arizona (D.T.S.)

    Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands (M.D.K., G.J.A.D.)

    Leiden University Medical Center, Leiden, The Netherlands (M.D.K., F.E.S., G.J.G., A.F.C.)

  8. Adam F. Cohen Aachen Centre for Human Drug Research (CHDR)

    Leiden University Medical Center · Critical Path Institute · Centre for Human Drug Research · Haga Hospital · Juliana Kinderziekenhuis

    Affiliation as printed

    Centre for Human Drug Research, Leiden, The Netherlands (M.D.K., F.E.S., V.E., R.J.D., G.J.G., A.F.C.); Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands (M.D.K., G.J.A.D.); Leiden University Medical Center, Leiden, The Netherlands (M.D.K., F.E.S., G.J.G., A.F.C.); and Critical Path for Parkinson's Consortium, Critical Path Institute, Tucson, Arizona (D.T.S.) ac@chdr.nl

    Centre for Human Drug Research, Leiden, The Netherlands (M.D.K., F.E.S., V.E., R.J.D., G.J.G., A.F.C.)

    Critical Path for Parkinson's Consortium, Critical Path Institute, Tucson, Arizona (D.T.S.)

    Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands (M.D.K., G.J.A.D.)

    Leiden University Medical Center, Leiden, The Netherlands (M.D.K., F.E.S., G.J.G., A.F.C.)

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References 42