June 23, 2017
Learn why digitalization of clinical trials is a winning bet
By: Ian Shafer

The next decade promises both tremendous potential and significant disruption for the biopharmaceutical industry, as companies transition their focus from blockbuster products and volume-based models to specialty products and value based models. Both science and development operations are becoming increasingly more complex, with an average drug development cost of $2.6 billion per product1. As development costs and complexities soar, stakeholder (patients, investigators, payers, etc.) expectations continue to evolve at pace with technology advancements creating the need for a more convenient and personalized approach for product.

Fortunately, new digital technologies exist to optimize the clinical development process, and more broadly the entire Research and Development (R&D) value chain. Research shows that digitalization will be fueling one-third of the growth and an estimated 40 percent of the profitability in the pharmaceutical market by 2020.

R&D executives recognize digital as a primary driver to deliver patient outcomes, and companies that embrace digital report stronger performance across several key R&D capabilities. Yet, many companies have been slow to embrace digital at an enterprise level, due to:

  • Perceived compliance risk.

  • Evolving regulatory guidance.

  • Technology maturity.

  • An ambiguous return on digital investments.

Overall, the industry’s adoption of digital lags that of other industries and stakeholders’ expectations.

Digitization or digitalization?
Gartner rightly defines digitization and digitalization as two different activities:

  • Digitization is simply changing from an analog to digital form.

  • Digitalization is leveraging technology to revamp a business model to invoke new value-producing capabilities.

We believe R&D organizations, and pharmaceutical companies more broadly, should boldly embrace digital technologies, rethinking both operating models and cultures.

In the past, companies have experimented tepidly with digital technologies. For example, in the early 2000s, enterprise Electronic Data Capture (EDC) solutions offered the potential to significantly reduce the data entry burden to sites and increase speed to high-quality clinical trial data. However, the capability was not transformed holistically—paper-based systems were simply replaced by digital tools without a thorough consideration of how the technology could revolutionize clinical trial data capture. As a whole, industry missed out on the expected value proposition, and today, nearly 20 years later, paper studies are still in use.

Unless our industry confidently embraces the holistic digitalization of R&D, the coming era will simply continue a slow trend of turning analog processes digital.

The vision: end-to-end digital clinical trials
Many R&D organizations are evaluating individual, niche use cases for digital technologies within the clinical trial process, such as the use of wearables and electronic informed consent. But surprisingly few are exploring digitalization of the end-to-end clinical trial process even though there are broad opportunities to add value across all clinical trial stages. Learn more about the value gained from digital clinical trials from trial design, trial start-up and during trial conduct and closeout.

In our next post, we’ll take a closer look at winning digital strategies available at each stage of the process.

1Cost of Developing a New Drug. 2016. Tufts Center for the Study of Drug Development.

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