Clinical trials, including the four phases regulated by the Food and Drug Administration (FDA), require several steps for patient consent and processing with the Institutional Review Board before drugs are safely released to market.
Informed patient consent involves making the patient aware of each step in the Clinical Trial process including any possible risks posed by the study.
During Phase I, healthy volunteers test the safety of the drug. Phase II, which can span as long as two years, often includes blinded studies where one group of patients receives the experimental drug while another group of patients receives a placebo. During Phase III, a more robust number of patients (often in the thousands) are tested for drug efficacy. Lastly, Phase IV trials, also called Post Marketing Surveillance Trials, test to compare the marketed drug to the current alternative drug options that exist (1).
Since the passage of the Prescription Drug User Fee Act in 1992, which allowed the FDA to receive funding from pharmaceutical companies, some patients and physicians have begun to question the current standard for Clinical Trial funding. Among the sceptics is Avalere Health, a healthcare consulting firm based in DC. According to their 2017 report, the FDA has collected $7.67 billion in user fees from pharmaceutical manufacturers since the passage of the 1992 Act. Furthermore, the report shows a trend of increasing annual funding to the FDA from drug manufacturers, as shown in the graph below (2).
A majority of the mistrust in this process stems from prior knowledge of fraud in the proceedings. For example, prior knowledge of the Tuskegee experiments showed negative correlation with willingness of certain African American patients to participate in clinical trials. “Other examples of misconduct include the 2007 case regarding the clinical trial on the safety and effectiveness of oral telithromycin and amoxicillin/elavulanic acid in outpatients” (5). A survey on 717 adults in the United States found mounting distrust in clinical research staff in 2007, (3) when user fee rates at drug manufacturers surpassed $1,000,000. This lack of trust often hinges on consent signing prior to participation in the Clinical Trial proceedings.
“Indeed, the US Food and Drug Administration reports that almost 10% of the trials that they monitor feature issues related to consent collection: failure to obtain written informed consent, unapproved forms, invalid consent document, failure to re-consent to a revised protocol and missing Institutional Review Board approval to protocol changes” (4).
One of the ways to combat this growing mistrust and lack of organization is to turn to decentralized, immutable ledger technology like blockchain. Decentralizing the network and placing patient consent forms on a blockchain ledger hinders pharmaceutical manufacturers from monopolizing the process and limits fraudulent proceedings.
In particular, Benchoufi and Ravaud, two researchers in Paris, France from Hospital Hôtel Dieu, have done the preliminary work to investigate the application of Blockchain in clinical trial consent-taking efforts.
This team of researchers designed a Proof-of-Concept in which each step of a patient’s consent was time-stamped and encoded on the blockchain in an immutable fashion as shown in Figure 1 below (5). After receiving and approving an email for partaking, each participant was assigned a private key that aligned with their digital signature.
By designing a platform for patient consent documentation on the blockchain, the Benchoufi research team created a consensus standard model in which all stakeholders are satisfied in the Clinical Trial regulatory process while also minimizing informed patient consent documentation error.
Published in 2017, the team chose the Bitcoin blockchain as opposed to the Ethereum blockchain due to the Bitcoin “multisig” feature which allows for multiple signatures on a single transaction.
Additionally, the IFTTT function used in conjunction with blockchain technology enabled proper verification in the following fashion: Only if patient consent registration linked to the patient’s unique digital signature had taken place, then could the patient join the Clinical Trial. This prompted the formation of several smart contracts.
A smart contract, an example of which is the IFTTT contract, is data deployed to the blockchain, in particular ethereum’s blockchain. It enables the exchange of an immutable transaction with various trusted third parties. Smart contracts can store information, transmit information, and perform calculations.
Benchoufi, Porcher, and Ravaud’s efforts stand out as an example of how blockchain can be applied in the healthcare industry to streamline informed patient consent proceedings and limit fraudulent practices, thus restoring consumer trust in the market.