By Premdharan Meyyan, senior consultant, Fuld + Company
According to a common refrain, blockchain will “transform” and “disrupt” the life sciences industry. While the technology’s applications in industries such as banking and broader financial services are readily apparent and, in fact, already being adopted, tangible applications in the life sciences prove more nebulous.
Fuld + Company conducted an analysis aiming to nail down the areas within the life sciences industry in which blockchain shows the most immediate promise. Our findings suggest clinical research being conducted in the context of new drug and device development is the area most ripe for innovation using blockchain. The immutable nature of the technology holds the key to answering concerns around data transfer, data integrity, and overall transparency of the clinical development process for both internal and external stakeholders.
A Primer on Blockchain
Blockchain, in its most basic form, refers to a series of blocks connected to one or more computers using a peer-to-peer (P2P) network. Each block contains readable data, and all computers in the network must provide unanimous approval before new blocks are added to the chain. The key is that as new blocks are added, old blocks maintain a completely immutable record of the history in that blockchain. In this way, one can build decentralized or distributed databases, where responsibility for information stored in the database is shared among multiple parties.
This immutability is the defining characteristic of the blockchain, as it is practically impossible to modify data within existing blocks without consensus from all parties involved. The fact that blockchain can be used to record and transmit any structured information, not just transactions, in the form of “smart contracts” results in significant opportunities for clinical research executives.
Clinical Trial Applications
Fuld + Company recently provided analysis on the potential for wearable devices that allow for remote patient monitoring in clinical trials. A natural extension of this subject is a dialogue about how this data is collected and stored. In a traditional client-server architecture, anybody with the proper user permissions can read and write data outputs from these devices.
Consider a real-world use case of a wearable device collecting real-time inputs where the effect of a novel therapeutic on heart rate is being investigated. In this scenario, the investigator uses a wearable device to monitor a patient’s heart rate. Data related to cardiorespiratory activity will be collected and stored somewhere locally (either on the device itself or a nearby computer). The stored data will then be transmitted to a remote, centralized server for collection and aggregation.
Now, consider a case in which, rather than sending this data to a remote location, it is stored on blockchains in which each block contains raw data on the patient’s heart rate at a discrete time point. The decentralized nature of the blockchain means all parties with a vested interest in the outcome data (e.g., the site staff, pharmaceutical company, CRO) have access to the information stored in the database, but no modifications can be made without consensus. This means even if a single party has an interest in hiding or modifying certain outcome data, there is no practical way to do this without resorting to conspiratorial unethical practices. Theoretically, this provides all inside and outside parties with greater confidence in the integrity of the data being collected by improving overall data completeness and accuracy while simultaneously avoiding selective reporting.
Although the model is intriguing, several challenges must be considered. First, inefficiencies may occur when changes need to be made to the study protocols or outcomes on the fly due to the underlying consensus mechanisms. Second, studies have shown that decentralized models were more costly than centralized databases in the context of multicenter clinical research studies. If these challenges can be overcome as the technology matures, it is clear the model has utility in clinical research, particularly to improve data robustness and integrity at the trial level. When extrapolating this to the broader universe of clinical research, there is also potential to improve the robustness and accuracy of clinical trial registries.
While registries are useful tools for practitioners, patients, and industry professionals to track historical, ongoing, and planned clinical trials, they present challenges in gleaning critical information from the database. There are often inconsistencies with what information is available and how frequently it is updated from trial to trial. With an ever-increasing therapeutic pipeline driven by new drug discovery tools and methods coupled with the ubiquitous need for new treatment solutions, it is increasingly important to have a reliable, complete, and up-to-date source of information.
Again, considering the previously described heart rate scenario, one can envision a future in which the data inputs from the patient are anonymized, aggregated, and fed directly to blockchains, which are further aggregated into a single trial record that is available to the public. Something like this could form the clinical trial registry of the future, assuming proper encryption protocols are established and buy-in from all stakeholders in the development process is established.
How will these applications translate to returns for the clinical development process’ stakeholders? In other words, is this a true benefit for pharmaceutical and device companies, or does it just open a can of worms? With current systems, it is difficult, and in some circumstances impossible, to find information on why certain therapies don’t progress past a certain stage. Was it a safety concern? Funding issue? If there was a serious safety concern, does the development company even want that information disclosed to the public and, by extension, potential licensees, investors, and customers?
Keeping the long-term picture in mind, our analysis suggests, yes: it is in life sciences companies’ best interest for the industry to be as transparent as reasonably possible around clinical trials. First, taking concrete steps to increase transparency only increases the public’s trust in the process, especially in a climate marked by a high level of disillusionment with Big Pharma. Second, over longer periods of time blockchain technology will narrow knowledge gaps by making it possible to conduct more comprehensive, objective reviews of why certain classes of drugs did not meet endpoints, which will help inform future drug discovery and development. Third, prescribers can have more confidence the treatments they select have been robustly evaluated for safety and efficacy, and they can access the data to conduct their own analysis. The result across the board is enhanced brand loyalty and customer retention.
One consideration that must be made centers around the high costs and rigid frameworks associated with decentralized data management models. Blockchain technologies, like any new approach or archetype, may pose a threat to current paradigms. Yet, overall, these blockchain applications will move the industry toward a more community-driven form of healthcare in which all stakeholders have the ability to provide checks and balances on the development process. In turn, the quality of therapies being developed will improve, as will outcomes for patients.
About The Author:
Premdharan Meyyan is a senior consultant at Fuld + Company, based in Boston. He has several years of experience designing and delivering market research and consulting solutions for clients in the life sciences industry through robust market and competitive analyses and monitoring broader industry trends. He has worked across several therapeutic areas in both pharmaceuticals and medical devices, with a large focus in oncology, urology, women’s health, ophthalmology, and cardiovascular. Meyyan received a B.S. in biomedical engineering with concentration in nanotechnology from Boston University. You can reach him at firstname.lastname@example.org.