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Virtual Clinical Trials

Despite being one of the most expensive parts of the modern healthcare, clinical trials are not as effective as they need to be, low recruitment particularly hindering their success.

The clinical trial market continues to grow at an astronomical rate. In 2000, there were only 2,119 active trials, while now lists upwards of 280,000 active clinical research studies. The market’s value is predicted to reach $65.2 billion by 2025.

Context & Challenges

Clinical trial research is one of the most costly parts of modern healthcare, with each trial valued at $100 million on average, pushing up the cost of developing a single new drug to up to $2.6 billion. This cost varies according to therapeutic area, with oncology and immuno-modulatory drugs being the most expensive to develop and sitting at a median of $2.8 billion and a mean of $4.5 billion.

Calculating these costs is also dependent on the success rate of trials, many of which are still unknown. Oliver Wouters, Assistant Professor of Health Policy at the London School of Economics estimated that trial success rates of 14% for experimental drugs entering Phase 1 clinical trials, 35% entering Phase 2 and 59% entering Phase 3.

Despite the price tag, often trials are clearly not as efficient or productive as they could be, and fewer than 1 in 10 drugs that go through clinical trials make it to market. As Dr. Uli Brödl, VP for medical and regulatory affairs at Boehringer Ingelheim observed. “The clinical trial ecosystem is highly complex as it involves different stakeholders, resulting in limited trust, transparency and process inefficiencies without true patient empowerment.”

One of the greatest hindrances within the clinical trial process is the difficulty of patient recruitment. A 2011 Tufts Report showed that around 20% cancer clinical trials fail due to low patient recruitment rather than issues with the drug. These means that many potentially life-saving drugs are not making it to the market.

Up to 30% of the clinical product development lifecycle suffer long and expensive patient recruitment cycles with a typical Phase III clinical trial taking nine months to finish enrollment and costing up to $86 million.

More concerning, over 10% of investigator sites fail to enroll a single participant, meaning that much of this cost is sunk.

Only 5% of the US population participates in clinical trials today because trials are often inaccessible, and the consent process is cumbersome and time-intensive.

  • Patients
    Patients can reap significant financial benefits from clinical trial participation, however, are prevented from doing so by the inconvenience at hand.
  • Pharma Companies
    A successful clinical trial can generate millions to billions of dollars for pharma companies’ market cap, but a failed one can cause irreparable damage.
  • Society
    If potentially life-saving drugs do not make it to market because of fixable factors like patient recruitment, society is inevitably worsened.
  • The FDA
    The FDA must process labor-intensive patient recruitment and clinical trial administration, often to little effect. With more streamlined systems, resources could be redistributed more effectively.

The Good News

In July 2019, ALTEN CalSoft Labs and BlockApps launched BioPharma Ledger, a blockchain clinical trial platform focused on resolving many of these inefficiencies.

STRATO digitizes the bulk of clinical trial procedures by providing a single ledger within which data can be stored, communicated, and updated in real-time, saving pharmacy companies 25% of an average ten-year drug development or $273 million.

As such, participants in trials can transmit data through wearables or remotely, as well as complete consent processes digitally. Moreover, STRATO encrypts data so that patient privacy is ensured and patient and trial data can be stored in the same place. This could radically increase incentive to participate, which in turn would decrease costs of recruitment, increase clinical trial efficiency and drive faster production of new drugs, with far-reaching implications for society.

Researchers, clinicians, patients, and the drug industry could all massively benefit from such innovation, with a rapid onboarding promising to save up to 6 months or $54 million on average.

Solution Benefits

  • Encrypt data to protect sensitive patient information and address security concerns
  • Spin private chains to immediately and securely provide access to data to new permissioned parties
  • Store all data in one consolidated ledger to allow seamless communication along the complex clinical trial supply chain
  • Digitize processes to allow patients to participate remotely through wearable devices
  • Use Smart Contracts to allow patients to digitally complete consent forms and automatically execute certain terms

Any STRATO insurance solution leverages STRATO’s enterprise grade features

  • RESTful APIs for direct connection of IoT devices such as provider’s iPads to the blockchain network
  • Identity Management, OAuth and SSO capabilities for simplified IoT authorization and user login for permissioned parties
  • Privacy via private chains to keep sensitive data private and secure
  • Enterprise Data Modeling for integration of relevant data from previous trials