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).
J Natl Cancer Inst. 2014 Sep 12;106(10). doi: 10.1093/jnci/dju258. Print 2014 Oct.
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.
患者和医生对试验的认识和接受程度，以及患者的不适合参加某项试验的情况，是癌症临床试验入组的主要障碍。然而，试验通常是由少数研究人员组成的团队构思和设计的，患者的参与度有限。我们假设，通过众包，大量研究人员、临床医生和患者的智力和创造力可以被利用起来，以改进临床试验设计过程。在这项研究中，我们评估了使用基于互联网的众包平台来为一项临床试验提供信息的可行性和实用性，该试验旨在探索二甲双胍这一抗糖尿病药物在前列腺癌中的应用。在六周的时间里，从 60 名医生/研究人员和 42 名患者/拥护者那里收集了众包输入，导致对最初设计的临床试验方案进行了几项主要（例如，资格）和次要的修改。众包临床试验设计是可行的，为方案开发过程增加了价值，并可能最终提高试验实施的效率。
