Transparency Protocol Crowdsourcing
TLS’s web-based protocol crowdsourcing survey tool is designed to obtain input into clinical trial protocols from patients, community-based physicians and other stakeholders, delivering clinical trial protocols that are more relevant and patient-centric, especially when integrated with TLS’s personalized digityping and virtual clinical trials platforms. The crowdsourcing process helps optimize sponsors’ protocols in key design areas. Importantly, it also tests the feasibility of completing study tasks remotely from home or work, and delivers clinical protocols ready to be executed via TLS Virtual Trials .
TLS’s crowdsourcing surveys present “challenges” (questions) about key design elements in a form that is tailored to a global community of patients and professionals. The goal is to enhance but not replace internal judgment and the insights of key opinion leaders who bring specialized expertise to the clinical project. TLS has applied its proprietary crowdsourcing tool successfully to protocols for CNS, cancer, autoimmune, and rare diseases. The TLS crowdsourcing approach has received strong support from FDA representatives, and from IRBs at top-tier academic centers, including Brigham and Women’s Hospital, The Icahn School of Medicine at Mt. Sinai, and others.
The TLS protocol crowdsourcing effort enables global access, whereby patients and professionals from all regions of the world can participate via the internet, but this is not a requirement. Projects can be tailored to specific organizations and regions, and even within a single institution or company via a private web link.
At the end of the open input period, leading crowdsourcing participants – designated as Super Users – may be invited to form a small work group that collaborates with the sponsor study team over a private network, to help hone the study details or respond to additional questions from the sponsor. Once this process is completed, the TLS clinical team analyzes the quantitative and qualitative feedback, and works with the sponsor to finalize the clinical study protocol.
Contact us to learn more about Transparency Protocol Crowdsourcing.
|What It Is||What It Does|
|Transparency Protocol Crowdsourcing||Web-based surveys, incentive system that recognizes outstanding participation, and data analysis methods||Turns input from patients and professionals into optimized protocols|
|Software platform, mHealth devices, and related methodology||Integrates the software systems that collect patient data outside of the clinic|
|Transparency Personalized Digityping||Software platform, mHealth devices, and data aggregation services||Aggregates mHealth data for patients’ self-monitoring and industry analysis|