The management of Clinical Trial has so many different moving parts and participants that people often ask “How is Pharma ever going to improve the Clinical Trial process?” Well, there are several challenges that are universal to all Clinical Trials. For example: Site Selection, Investigator Enrollment, Patient Enrollment, Data Management, Sites Advertising, etc. This list does not include challenges that are specific to a trial: there are often insufficient patients who are eligible for the trial (this is often the case for rare diseases); some sites may not pass regulatory inspections; a preferred Investigator may have received an FDA Warning Letter, etc. The Pharma companies will eventually complete the trial but at what cost? When conducting a Clinical Trial, the goal is to enter the first and last patient into the database as quickly as possible, so that the database can be ‘cleaned’ by Data Management and locked. If patients can be enrolled in a timelier manner, the Pharma companies would save a tremendous amount of money and reduce the time it takes to complete the trial. In turn, the faster a trial is completed the faster patients can get access to life-saving drugs; it often takes years to get FDA approval, so this is especially important to people with rare disease who have no other treatment options. This is where the Blockchain and Digital Tokens could really advance the Clinical Trial process.
By implementing a Blockchain solution (like BlockRx™ from iSolve) to support the clinical and patient data, the Pharma companies can now establish a different strategy and approach towards patient enrollment without having to replace their current CTMS (Clinical Trial Management System):
- Greater Integration with the Sites
- Improved Data Transparency and Visibility
- Global Access to data and studies
- Ability to incentivize both Patients and Investigators
Because of the inherent nature of the Blockchain, storing de-identified patient data and clinical records becomes more dynamic with the ability of the Blockchain to hash transactions and provide providence. The decentralized functionality of the Blockchain allows for all sites and business units to have integration and visibility into the trials and the status of the enrollment data. But this is the biggest bonus: The ability to incentivize Patients and Investigators with Digital Tokens. By leveraging solutions like ADLT™, patients can login to an app and enter or update information about their profile; take surveys and sign up for trials. By completing any one of these actions, the patients can be awarded Digital Tokens (like BKRx from BlockRx) and leverage them for discounts on medicines, copayments or exchange them for fiat currency. This provides greater incentive and motivation for patients to get involved and participate in the trial. In addition, when Investigators validate the data and provide additional data, the Investigators would receive tokens as well. This would create an additional revenue channel for the Investigators, Practitioners, and Sites. This type of investment by the Pharma company could easily offset the cost of implementation and token incentive. More and more Pharma companies are starting to realize that by incentivizing the Investigators and Patients in this manner, the goal of expediting the trial becomes much more of a reality within a model that could be replicated.