SUBJECT, PROTOCOL AND PHYSICIAN AWARENESS BARRIERS. The system educates patient about their diagnosis, current available treatments and aspects of clinical research and eliminates significant patient barriers: patient perception vis-à-vis of clinical trials (by putting patient in charge in a game setting where there is no commitment and nothing to lose), lack of awareness about clinical trial availability, access logistics to study personnel, trial fit/matching, enrollment hurdle The system also crowdsources trial design, allowing study sponsors to determine already interested patient communities with specific characteristics for particular type of studies before the official study protocol is written. The highest bidder win system insures the sponsor has the funds for the study being considered and the number of nonperforming or low performing site activations can be eliminated by having the study candidates pre-identified.
Treating physician obstacle (Concern of loss of control, lack of awareness of clinical trial sites and suitability for their patient, lack of time to discuss issue)
Work around: Trusted physician will prescribe application to patient, remaining a trusted advisor and proving value added activities that differentiate his/her practice from the competitors.
Patient obstacles: Rationale and motivation to use the application
Work around: Application is a game making it fun. Social networking aspects of the game allow interactions with a community of patients with the same diagnosis creating an instant support group.
Fast and effective identification of interested patient subjects grouped by cancer diagnosis and other elements will lead to a pre-identified cohort of patients. These patients will be matched with existing studies or will trigger the initiation of a targeted clinical study protocol design that will have close to or 100% accrual rate. Pilot data will be obtained after application implementation in one geographical test market- one type of cancer diagnosis- and will prove the concept within a short period of time (depends how many applications are prescribed, downloaded and how fast the game/application gets played and adopted by the test market).
CTCP design will include options and customization of the game to identify interested customers in all types of trials: treatment, screening, prevention, diagnostic, supportive care, behavioral. Sustainability will depend on
• Attractiveness of the game
• Buy-in of the prescribing physicians
• Patient and patient’s social circle as influencers
• Social effects of crowdsourcing platform
• Responsiveness of the Clinical Trial Warehouse with fast bid adjudication and constant feedback to patients
• Responsiveness of bid winners with immediate “ownership” of patient data and patient relationship design and management
• Constant communication with patients leading to fast enrollment or notification of alternative options for particular diagnosis
None contemplated with HIPAA compliant application in a form of a physician initiated prescription and patient consent. Social media participation will only be done at patient initiative and will not include data subjected to HIPAA regulation.
Solution has not been tried before because a patient initiated and centric approach in oncology clinical trial design has not been considered. Although CTCP is not effectively a clinical trial design effort, it links the trial subjects, their demographic, inclusion and exclusion criteria data, willingness to participate in a study and creates a social support network with instant advertising/marketing capabilities.
By matching users with content and collecting, curating, analyzing the data, CTCP delivers to the trial sponsors a ready- made cohort for a clinical trial that can write itself. CTCP patient database can be mined constantly after patient initial consent for future study suitability
