How Blockchain Can Improve Clinical Trial Design

October 30, 2019

Blockchain technology can improve clinical trial design by ensuring the validity of consent forms and the security of patient data.

Although most data generated through clinical research is digitized, concerns about patient privacy, the prevalence of cyberattacks, and the lack of interoperability standards present significant barriers to data-sharing between healthcare institutions. Even when data is shared, manually entered data can be error-prone or incomplete, and verifying information is often time-consuming and expensive.

Fortunately, the rise of blockchain technology may provide a surprising solution to concerns about data security and accuracy in clinical trials. Blockchain is perhaps best known for underpinning cryptocurrencies such as bitcoin, but its potential applications are much more expansive. Here’s how the technology is revolutionizing clinical trial design and patient recruitment.

Blockchain’s Growing Role in Clinical Trials

Blockchain is a decentralized, distributed ledger that keeps track of unchangeable data. By using cryptography, it can ensure that different copies of data are identical without centralizing information in a single database.

A recent study in the BMJ proposes that blockchain technology can improve clinical trial design by “ensuring transparency and yielding better quality data.” In particular, using blockchain during auditing helps ensure that forms are complete and accurate without changing the patient interface. In this way, blockchain is capable of solving administrative problems while maintaining a positive, convenient experience for patients.

As blockchain technology matures in industries outside of cryptocurrency, healthcare leaders are already investing in the technology. According to Deloitte’s 2019 Blockchain Survey, healthcare executives are among the most enthusiastic about the possibilities of blockchain. Additionally, an IBM survey found over half of healthcare institutions believe that blockchain can improve administration in the areas of clinical trial records, medical records, and regulatory compliance.

Sharing Data – Without Sacrificing Security

During the drug development process, data is shared between multiple stakeholders including researchers, patients, sponsors, and CROs. Blockchain makes it impossible to change individual sets of data without changing the chain, enabling administrators to integrate existing databases while keeping them distinct. By timestamping changes to data in different locations, blockchain can prevent unwanted tampering and ensure that multiple sets of data are accurate.

Beyond ensuring data accuracy, blockchain technology can also play a crucial role in the regulatory auditing process by monitoring the validity of agreements, contracts, and consents. For instance, blockchain-enabled smart contracts can notify relevant parties of noncompliance or missing signatures, eliminating common problems that prevent patients from moving forward with clinical trials.

The Many Benefits of Blockchain

For sponsors and CROs, blockchain offers the added benefit of improved patient recruitment and retention. By integrating existing patient information and clinical trial databases, blockchain technology can connect patients to the trials that interest them most – while still restricting access to sensitive personal information.

An increasing number of clinical trials are leveraging wearable devices to more closely align trial design with patient needs, and blockchain technology can streamline this process by strengthening security as data transfers between individual devices and clinical trial data servers. Further, by removing barriers to data-sharing without compromising security, blockchain solutions can build trust between patients, researchers, and sponsors.

For medical marketers, blockchain-enabled data-sharing may mean significant enhancements to smart marketing capabilities. However, until blockchain technology becomes more widespread, digital marketing remains the fastest and most direct way to reach potential patients.

In particular, the increasing sophistication of Google display and Facebook ads helps clinical trials reach relevant patients based on demographic data, geography, and interests. Search ads through engines like Google and Bing can help sponsors and CROs connect with patients and their caregivers who are already seeking treatment options. Combined with robust analytics and performance tracking, these digital marketing tactics can create significant results for clinical trials that need a patient recruitment and retention boost.