Digital technology has driven improvements in industries like banking, retail, and finance. Now, these tools have the power to transform clinical development as well.
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According to Deloitte, the current R&D model in biopharma is thought to be unsustainable. Return on investment in pharmaceutical R&D is dropping (10.1 percent in 2010 to 3.2 percent in 2017)[i], in no small part due to the inefficient production of data. Some clinical trial activities still use the same processes from the 1990s, despite rapid technological change since that time.
An improvement in harnessing data could result in new treatments and better results for patients. As stated in “Digital R&D: Transforming the Future of Clinical Development,” digital technology can fundamentally transform the approach to clinical development by “incorporating insights from multiple sources of data, improving the patient experience, enhancing clinical trial productivity, and increasing the amount and quality of data collected in trials.”
Potential of Digital
Most companies currently view digital as a collection of technologies like AI, machine learning, and robotic processes that can be applied to solving problems. Companies are looking for digital tools to take on operational activities like recruiting patients and capturing, then analyzing, data.
The goal, however, should be to get away from a narrow viewpoint where digital is a solution or tool for an individual problem, and instead focus on how these technologies can help accomplish bigger objectives and identify opportunities, like addressing pain points faced by patients and staff in clinical development.
Companies should start looking through a digital lens and accept this shift as a new way of doing things. Deloitte points to three main opportunities that digital technologies have the potential to transform in biopharmaceutical R&D: the way companies engage, execute, and innovate.
Engage — Effective engagement with patients and stakeholders can help establish and improve relationships. Mobile technology, in particular, could make clinical experiences more patient-friendly, eliminating needless visits, recording health data, and reminding patients to take medications.
Innovate — Digital can drive patient care innovation by accelerating the development of products and services, providing value for all parties involved. Digital tools can deliver value by collecting data more frequently via sensors or wearables, generating more data, and enabling shorter studies and a reduced need for study subjects. Applying artificial intelligence and advanced analytics to existing data can also help reveal new insights based on real-world evidence or other studies.
Execute — Executing with efficiency through digitized processes helps reduce cycle times and optimize cost savings while addressing operational efficiencies. Digital tools can ease the manual burden for repetitive tasks, improve recruitment by reducing the effort required in patient identification, and make data-driven investigating more productive through automated data capture and data sharing.
Current State of Digital
Deloitte interviewed 43 leaders in the clinical development sector, and found that the industry has lagged in digitizing clinical development processes. They also discovered that digital adoption varies greatly. Even the most advanced biopharmas are largely “focusing on piecemeal solutions or new tools to support the existing process.”
Wholesale changes or fully digitized processes have been slow to be implemented because digital transformation is viewed as a complex, resource-intensive undertaking. Most interviewees admitted that biopharma has been slow to experiment with, and integrate, digital technology—despite being aware of its potential.
Interviewees expressed the sentiment that companies are taking a wait-and-see approach, waiting for someone else to make the first move. However, they agreed that once early adopters get regulatory approval and have a working digital approach, adoption will follow rapidly.
There was a prevailing theme that the benefits of innovating—as opposed to waiting—outweigh the risks. The global head of pharma portfolio management in a large biopharma company remarked, “The risk that you take the wrong bet is probably smaller than the risk of not moving.”
Pilot programs, Deloitte believes, can prove to be valuable learning experiences, even if the programs themselves don’t result in resounding success. Those that start sooner have a better chance of finding success than those who try to follow.
Considerations for Future Adoption
Deloitte points out several current barriers to adoption when it comes to digital R&D, the first of which is immature data infrastructure and analytics.
Interviewees described how many data of today’s archaic platforms are not conducive to digital innovation. The industry will need to design data systems that can enable real-time analysis and secure data-sharing throughout the clinical trial process.
Regulatory considerations are also a current stumbling block. However, interviewees noted that regulatory agencies are seemingly open to new solutions, and dialogue with these agencies can inform a course of action to incorporate new tools and set a path for future adoption.
More stringent privacy rules and regulations in EU countries make the U.S. the most conducive market for adoption, followed by Asian markets. Future improvements in connectivity and mobile device acceptance are likely to drive adoption in other parts of the world.
Another obstacle mentioned is internal organizational and cultural barriers. Interviewees conveyed the belief that clinical development has a risk-averse culture where innovation is often siloed away from the rest of the organization. Experts suggested change management activities like education about new processes and technologies, creating incentives for collaboration between teams, and embedding innovation champions in clinical teams.
Adoption may be hindered by a lack of tangible metrics to measure success, as few companies can really assess ROI in their pilots. It is also hurt by a talent shortage, making the development of in-house expertise in the areas of analytics and technology paramount.
Despite the barriers, Deloitte suggests that adopting a digital mind-set should become a new “business imperative.” Digital R&D is necessary in the clinical development field to process the massive amounts of data effectively and to generate value. The next few years will likely be a period of digital evaluation, but experts have suggested starting a transformation sooner rather than later.
Authors: Dawn Anderson, Jonathan Fox, Natasha Elsner
[i] Mark Steedman et al., A new future for R&D: Measuring the return from pharmaceutical innovation 2017, Deloitte Centre for Health Solutions, 2017, p. 4, accessed January 24, 2018.