title: Use of crowdsourcing for cancer clinical trial development.
abstract: Patient and physician awareness and acceptance of trials and patient ineligibility are major cancer clinical trial accrual barriers. Yet, trials are typically conceived and designed by small teams of researchers with limited patient input. We hypothesized that through crowdsourcing, the intellectual and creative capacity of a large number of researchers, clinicians, and patients could be harnessed to improve the clinical trial design process. In this study, we evaluated the feasibility and utility of using an internet-based crowdsourcing platform to inform the design of a clinical trial exploring an antidiabetic drug, metformin, in prostate cancer. Over a six-week period, crowd-sourced input was collected from 60 physicians/researchers and 42 patients/advocates leading to several major (eg, eligibility) and minor modifications to the clinical trial protocol as originally designed. Crowdsourcing clinical trial design is feasible, adds value to the protocol development process, and may ultimately improve the efficiency of trial conduct.
authors.affiliation: Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY (AL, WKO, MDG); Platform Development Department, Transparency Life Sciences, New York, NY (TS, MF, AG); Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY (MD); Clinical Trials Department, AMC Health, New York, NY (JH).
authors.forename: Amanda
authors.initials: A
authors.lastname: Leiter
authors.affiliation: Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY (AL, WKO, MDG); Platform Development Department, Transparency Life Sciences, New York, NY (TS, MF, AG); Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY (MD); Clinical Trials Department, AMC Health, New York, NY (JH).
authors.forename: Tomasz
authors.initials: T
authors.lastname: Sablinski
authors.affiliation: Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY (AL, WKO, MDG); Platform Development Department, Transparency Life Sciences, New York, NY (TS, MF, AG); Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY (MD); Clinical Trials Department, AMC Health, New York, NY (JH).
authors.forename: Michael
authors.initials: M
authors.lastname: Diefenbach
authors.affiliation: Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY (AL, WKO, MDG); Platform Development Department, Transparency Life Sciences, New York, NY (TS, MF, AG); Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY (MD); Clinical Trials Department, AMC Health, New York, NY (JH).
authors.forename: Marc
authors.initials: M
authors.lastname: Foster
authors.affiliation: Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY (AL, WKO, MDG); Platform Development Department, Transparency Life Sciences, New York, NY (TS, MF, AG); Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY (MD); Clinical Trials Department, AMC Health, New York, NY (JH).
authors.forename: Alex
authors.initials: A
authors.lastname: Greenberg
authors.affiliation: Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY (AL, WKO, MDG); Platform Development Department, Transparency Life Sciences, New York, NY (TS, MF, AG); Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY (MD); Clinical Trials Department, AMC Health, New York, NY (JH).
authors.forename: John
authors.initials: J
authors.lastname: Holland
authors.affiliation: Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY (AL, WKO, MDG); Platform Development Department, Transparency Life Sciences, New York, NY (TS, MF, AG); Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY (MD); Clinical Trials Department, AMC Health, New York, NY (JH).
authors.forename: William K
authors.initials: WK
authors.lastname: Oh
authors.affiliation: Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY (AL, WKO, MDG); Platform Development Department, Transparency Life Sciences, New York, NY (TS, MF, AG); Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY (MD); Clinical Trials Department, AMC Health, New York, NY (JH). matthew.galsky@mssm.edu.
authors.forename: Matthew D
authors.initials: MD
authors.lastname: Galsky
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000379:methods*; D063045:Crowdsourcing / Q000379:methods; D005240:Feasibility Studies; D006801:Humans; D020407:Internet; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D009369:Neoplasms / Q000628:therapy; D018579:Patient Selection; D011471:Prostatic Neoplasms / Q000188:drug therapy; D012107:Research Design
chemical_list: D000970:Antineoplastic Agents; D008687:Metformin