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Value Proposition = Potential to obtain a CPIM with the FDA with the backup plan of COA tool pathway.COA info .
From page 2 of 6 FDA CPIM INFO DOC. Potential outcomes of CPIMs include efforts leading to:
- Regulatory submissions of clinical trials with new designs and methods
- Proposals for the use of emerging technologies
- Proposals for biomarker qualification or the use of biomarkers in regulatory submissions
- Natural history studies
- Public workshops and future collaboration of FDA with external parties
- Development of new guidance
- Formation of new consortia and public-private partnerships to advance regulatory science efforts
MVP Functions: Tracking of De-identified Patient Data for 2 Key Metrics. 1 is a MAJOR pain point to all parties involved and the other is patient reported outcomes via Quality of Life Survey.
Concomitant Medications (Con-Meds) - Medications taken by the patient before during and after study going back sometimes 5 to 10 years.
- Data fields for interface: ID, Name, Description, Dosage, Frequency, Start Date, Stop Date, Notes.
- QOL Survey - ID, Date, Time, Note, Field 1, Field 2, ...., Field 5. -as simple as it seems .
Lots of refinement still to happen in the next 18 hours but wanted to get this pushed out there for digestion and any and all feedback.
Tear it apart
The Clinical Trials industry is responsible the creation of therapeutic interventions and advancement of medical science. Despite the massive value generation and cashflows this multi-billion dollar industry is crumbling. Even the FDA agrees.
The TrialPhi Protocol is a tactically-timed, minimum implementation, clinical protocol template designed to ease the current strain on all stakeholder groups as the reorganization of the industry accelerates.
Key Features: Blockchain-Agnostic - complete abstraction of individual blockchains into a behind the scenes framework is not that far away and TrialPhi will ready when it happens. Patient-Centered - via outcomes reporting, engagement initiatives, and feedback loops as a governance mechanism Dynamic Endpoints - facilitating the change that is already happening and providing a common foundation to ensure everyone still keeps the same basic goals in mind.
Key Outcomes Improved Participation - from patients and researchers which is an outcome the industry will support and an everybody-wins scenario Reduced Regulatory Burden - 10 years is the average for a drug hit the market for drug approval TK *
from the laboratory white board to the one of the most complex mechanisms machines humanity has ever has such an opportunity existed where The TrialPhi Protocol is not designed to be the one protocol to cure them all