“The 21st Century Cures Act (2016) gave the FDA a mandate to accelerate regulatory approval for new treatments that incorporate the perspectives of the patients. This has led pharma to integrate “”real world evidence”” (RWE) into clinical studies. These include Electronic Health Records (EHR), Patient Reported outcomes and connected health sensors.
The problem is that current methods of collecting RWE are costly, slow and inefficient. Contract research organizations (CROs) typically take more than one year to compile RWE manually from industry silos, often completing this with more studies. Per patient cost of trials is $36,500 on average & $16,500 for phase 4. Patients are not compensated when their aggregated data is sold, and do not give explicit consent. Finally, aggregated data does not have the quality of individual patient-level data typically required.
On top of the $140Bn annual drug development market, pharmaceutical companies are buying expensive datasets, as shown by recent deals. For instance, Vertex pays $10,000 per patient per year to the Cystic Fibrosis Foundation. Roche bought Flatiron, valuing cancer patient records at approximately $9,500 a year..
To improve RWE, we replace centralized organizations by decentralized networks with Blockchain. We offer real-time data availability with smart-contracts without intermediaries, reducing time and cost. Allowing patients to set the terms and be compensated for their involvement offers higher resolution individual patient level data.