Transparency and Trust
The huge amounts of data created in clinical trials make it increasingly hard to share the information safely, keep it from being compromised, protect subject privacy and increase subject recruitment.
Developed to enable the online currency of Bitcoin, blockchain techniques allow for a high level of confidence between partners in a transaction, reports Sujay Jadhav in Forbes magazine. As he says, “The ability of blockchain to foster transparency and trust between parties has the potential to significantly disrupt the clinical trials industry. A recent study from IBM revealed that 16% of healthcare executives plan to put a commercial blockchain solution in place this year, while 56% expected to do so by 2020.”
In blockchain a group of linked computers holds and time-stamps data for which access has been encrypted, relating to transactions. Each element in the blockchain system independently confirms each data entry and stores it permanently. Because the data are diffused among multiple elements, it cannot be hacked or stolen. Finally, “immutability,” i.e., the provision that data are written once and can then only be read, is a key feature of blockchain.
Data systems using blockchain can link potential subjects with trial organizers anonymously. Pharma companies or the contract research organizations (CROs) that serve them can reach large numbers of potential participants and get enough information about them to contact and recruit them without names. This can speed up recruitment time, which can account for nearly a third of the total timeline for a clinical trial.
Blockchain makes possible the development of a new kind of data tracking of all patient-doctor encounters. Since most clinical trial results now are not reported, this could greatly increase the number that are, while allowing outside researchers to review the data.
Because blockchain includes time-stamping, coded access, read-only immutability once written and data that are held in multiple loci, it is virtually immune to fraud or changes of clinical trial results.
Informed consent can be a critical issue. Instances of failure to obtain it, use of incorrect forms and failure to get re-consent of a study is revised have all interfered with clinical trial progress. Blockchain can collect and time-stamp all consent data, demonstrating that proper consent has been obtained.
The US Food & Drug Administration (FDA) and the Centers for Disease Control (CDC) have started partnerships with IBM to develop blockchain techniques for patient records. This could signal a trend among government agencies.
As Jadhav summarizes, “From a global perspective, the application of blockchain technologies to clinical research is wide-ranging and promising, promoting data integrity, transparency and collaboration amongst partners, while increasing the availability of granular patient information in an anonymous fashion. Healthcare companies and regulatory agencies alike are excited about the new possibilities presented by this technology…Ultimately, patients stand to benefit, as blockchain technologies offer the possibility to further clinical research while improving patient safety and privacy.”