Clinical Trials are research studies that evaluate new medical treatments in order to discover better ways to detect, prevent, diagnose, and treat disease. Individual research studies are designed to answer specific scientific questions which are defined in the study protocol.

Successful clinical trials are responsible for the development of therapeutic interventions and advancement of medical science. This is an industry that is expected to grow to over 65 billion dollars globally by 2025 yet it is crumbling to the point that even the FDA admits that "clinical trials are broken."

With over 90% of medical records now stored electronically it might be hard to fathom that roughly this same percentage of clinical trial source documentation is still paper-based.

Data is often collected from trial participants on these clinical source documents and subsequently transcribed into the eCRF system which is the electronic study data management system. This is a hindrance to site staff and the physician investigators who are responsible for conducting these trials and ultimately has a negative impact on participant recruitment. Poor accrual is the number 1 reason why clinical trials are terminated prior to completion, especially when the sponsor is a private company, and this is the case regardless of whether the experimental treatment is effective or not.

Studies funded by the NIH are required to submit trial data within one year following the completion (or termination) of a trial. This requirement is part of the Food and Drug Administration Amendments Act (FDAAA 801) and was passed in 2007 as a means to expand the ClinicalTrials.gov database. Industry sponsored clinical studies are not subject to these same requirements and the data from many trials that that are terminated early is locked away. This is even the case for completed studies to some extent since private sponsors are very protective of their proprietary research.

This data is publically available since it is all de-identified and NOT subject to HIPAA regulations. Additionally, patients will often have already given their consent for the data to be used for further research upon enrollment in the study.

Imagine you find out you have cancer and it is terminal. The only treatments offered are palliative which will only help you be more comfortable in your final days but won't have any effect on fighting the disease. You are told that you are eligible to participate in a clinical trial for a drug that may be able to treat the type of cancer you have once it is approved. Participating is no picnic and regular visits are required to assess your progression but you being the altruistic soul that you are, decide to enroll so that there might be another patient later on who is able to be treated with this new drug.

How do you think it would make you feel to discover that the sacrifice you made for humankind was never allowed to make a difference because the trial was cancelled before completion?

The promises made to patients when they enroll in these research studies are not being as fully kept as they should be.

So yes, clinical trials are broken.

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 clinical trial industry accelerates.

• 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.

• 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 time frame for a drug to hit the market. We see that number being cut in half.

• Background
• Users
• Market Analysis
• Business Strategy
• Impact Validation
• Solution Technical Specs
• Refined Value Proposition 'Pitchdeck'
• Timing & Traction
• References & Resources