Clinical Research & Clinical Trials

Biography

Biography: F.X. Frapaise MD

Abstract

By design or by necessity, clinical trials protocol tend to evolve during the course of the investigation and patients must be kept abreast of any significant change to the protocol and consent in writing to the most recent versions of the protocol. Experience shows that the vast majority of patient adequately consent in writing to participate in a given trial, but that many investigators fail to ask patient to “re-consent” to the amended version of the trial.

This can have dramatic consequences, with all the data coming from a clinical center being discarded by the regulators in the analysis

To address this risk, Pharmacos and CROs deploy field monitoring resources and auditors to support investigators and detect this type of compliance issues as early as possible. Unfortunately the currently implemented risk-mitigation solutions by CROs only represent a wide-mesh net.

Blockchain technology, widely used and validated in the bank and insurance industries does provide an opportunity to address most of these consent management risks, as it provides a mechanism for immutable time-stamping of consent forms, storing and tracking of the forms in a secure and verifiable way. Blockchain technology provides a “single point of truth” for all partners involved in clinical research process, enables real-time synchronization of information between partners, while guaranteeing confidentiality and privacy as shared data can be encrypted.

In a time when many stakeholders tend to distrust data and information coming from the Pharmaceutical industry, Blockchain represent an opportunity to provide immutable and unfalsifiable data, hence increased shared trust between pharmaceutical industry and all stakeholders: patients/prescribers/ regulators.

Last, it should be mentioned that Blockchain benefits can also be leveraged in pharma supply chain management, contract management, prevention of counterfeiting.