Clinical Trials

Additionally, pharmaceutical companies have increasingly been focused on bringing more personalized drugs to the market at affordable prices. With market pressures, high government regulations, study complexity and the lengthy development process, costs of developing a new drug has raised to hundreds of millions, sometimes billions, of dollars. Large drug manufacturers such as Pfizer and Amgen view the data sharing and optimization gained through blockchain as a path towards more efficiently developing new drugs while keeping patients safe. The key word again is “interoperability”; reducing data silos is the key more data.

Blockchain technology can also greatly improve the transparency, quality and trustworthiness of clinical trials. Limited access to patient data makes it difficult to locate and recruit people eligible for a given clinical trial. This means added cost is involved to hire research organizations to find eligible participants. A blockchain system could allow potential participants to aggregate their anonymous health information in a visible location for recruiters. After a patient is contacted within the system and chooses to proceed, their personal information would be revealed. Automation of the patient contacting process while the trial is in action is another possibility.

On the result management side, ClinicalTrials.gov is the official public database of clinical trials in the US. Industry professionals report that the data is rife with problems including incomplete data, high participant dropout, hidden outcome switching, and selective reporting.

The result of these problems can be drugs which are actually ineffective or have harmful side effects can get approved, or drugs that are potentially very beneficial not completing the trial successfully in order to obtain approval.

By recording the protocol, test results, reports, paper and peer review documents in the proper time sequence with blockchain generated accurate timestamps, cryptographically signed, the clinical trial data will be built up in an immutable and theoretically unfalsifiable manner. Through the use of IoT devices, and secure (blockchain-based) time-stamping, the accuracy of collected data can be improved, and the number of collection locations can be increased to fit participant’s busy schedules, such that fewer participants will drop out resulting in a higher percentage of trials running to completion.

Currently, a big impediment to blockchain-based data systems being used in the pharmaceutical industry are the major traditional electronic health record vendors. But as the call for more control over the supply chain, results and patient records increases, these companies will have to adapt to the market.

References:

http://fabcoin.pro

https://www.trade.gov/topmarkets/pdf/Pharmaceuticals_Executive_Summary.pdf

https://www.worldfinance.com/special-reports/trade-in-illegal-medicine-hits-pharmaceutical-sector

https://www.coindesk.com/blockchain-day-big-pharma-seeks-dlt-solution-drug-costs/