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Development and Maintenance of a Preclinical Patient Derived Tumor Xenograft Model for the Investigation of Novel Anti-Cancer Therapies
Published on: September 30, 2016
Use of crowdsourcing for cancer clinical trial development
Amanda Leiter1, Tomasz Sablinski1, Michael Diefenbach1
1Department 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).
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.
Insights
Crowdsourcing clinical trial design is feasible and valuable. Harnessing collective intelligence from physicians and patients improved a prostate cancer trial protocol, potentially enhancing future trial efficiency.
Area of Science:
- Oncology
- Clinical Trial Design
- Drug Development
Background:
- Cancer clinical trial accrual faces barriers including patient ineligibility and limited patient input in trial design.
- Traditional trial design by small research teams may not fully address patient needs or optimize trial conduct.
Purpose of the Study:
- To evaluate the feasibility and utility of internet-based crowdsourcing for improving clinical trial design.
- To enhance a prostate cancer clinical trial protocol using collective input from diverse stakeholders.
Main Methods:
- Utilized an internet-based crowdsourcing platform to gather input on a clinical trial protocol.
- Collected data from 60 physicians/researchers and 42 patients/advocates over six weeks.
- Applied crowdsourced feedback to modify the trial protocol, including eligibility criteria.
Main Results:
- Crowdsourcing successfully generated input leading to significant protocol modifications.
- The process demonstrated feasibility and added value to the clinical trial protocol development.
- Identified specific areas for improvement in trial design through collective intelligence.
Conclusions:
- Crowdsourcing is a viable method for enhancing clinical trial design by incorporating broader perspectives.
- This approach can lead to more robust and patient-centered trial protocols.
- Implementing crowdsourced insights may improve the efficiency and success rate of clinical trials.
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