Technology could help biopharmaceutical companies pull more meaningful data from clinical trials and speed cycle times for products in development. Patients could see benefits, too, including higher satisfaction rates and better overall experiences during each phase of the trial. But, given the complexity of institutions and the broader drug environment, adoption has typically been slow and there are challenges ahead.
Clinical-trial model has not kept pace with technology
Biopharmaceutical manufacturers rely on technology to discover and develop breakthrough treatments that can turn deadly diseases into manageable chronic conditions—or sometimes cure a disease altogether. But the costs of developing a new therapy and bringing it to market can top $2 billion;4 and the research and development (R&D) process often relies on a clinical-trial model that has changed little since the 1990s.
Costs are now increasing faster than revenues, which makes this model unsustainable. A Deloitte analysis of the return on pharmaceutical R&D investments among 12 large biopharma companies revealed a sustained decline—from 10.1 percent in 2010 to 3.2 percent in 2017.
Technology also could help solve for some productivity challenges in the clinical-trial stage of drug development. The Center for Health Solutions recently interviewed 43 leaders across the clinical-development ecosystem in our new research, Digital R&D: Transforming the future of clinical development. We sought to understand how digital technologies are being used (or not) by biopharmaceutical firms. We also wanted to understand the relatively slow adoption of digital technologies in clinical development.
Despite the potential of digital technology, digital tools are generally not being incorporated into clinical trials. (In our research, the term “digital” covers a wide range of disruptive and emerging technologies, such as social media, artificial intelligence, wearables, blockchain, and virtual reality.) Surprisingly, many clinical trials still rely on paper. Even the largest and most technically advanced organizations are often only beginning to integrate digital technologies into their clinical-development processes.
What are the barriers?
Our interviewees certainly recognize the potential for digital technologies to transform clinical development. But they also acknowledge challenges, such as data infrastructure problems (including interoperability issues), privacy rules, and a lack of data standards. There are also regulatory and cultural considerations. These issues can make it difficult to take advantage of new technologies and data sources. Moreover, interviewees agreed that issues related to the safety, performance, and reliability of new technologies must be addressed before they could be included in clinical development.
What are the opportunities?
Based on our research, digital technology could help improve clinical trials and other R&D processes in the following ways:
- Reach and enroll a more diverse patient base: Digital technologies can help researchers more accurately assess trial feasibility, and adjust inclusion-exclusion criteria accordingly. This can help enroll a more diverse patient base more quickly compared to traditional approaches. Case in point: Using a cloud-based platform, a technology-enabled clinical research company recruited patients for a rare-disease trial 20–30 times faster than could have been possible using more traditional recruitment methods. The company sifted through patient records from hundreds of trial sites across the US, and recruited 372 patients from seven states. The result was a diverse study population.
- Remove barriers to trial participation: An estimated 70 percent of prospective clinical-trial participants live more than two hours from the nearest study center, which could impact their willingness and ability to participate.5 Along with travel time, participants might need to take time off from work, or find childcare. The ability to conduct virtual clinical trials could encourage more patients to participate. Taking part in a clinical trial without having to leave home also could ensure that fewer patients drop out once they sign up for a trial. Some interviewees estimate that as many as half of all clinical trials could be conducted virtually.
- Improve drug adherence: Ensuring medication adherence among patients is commonly an ongoing challenge during clinical trials, and it is becoming increasingly difficult as treatment regimens become more complex. Adherence ensures that the effect of an investigational drug is fully reflected in the data. Some adherence tools use facial recognition to confirm that a medicine has been ingested, and generate non-adherence alerts to investigators.
- Capture patient-centered endpoints: Many endpoints used in trials today offer just a glimpse into a patient’s physical and mental functioning. Advances in sensors and mobile technologies have made it easier to continuously collect patient-generated data. New technologies also make it possible to electronically gather patient-reported outcomes, including the ways an intervention impacts a patient’s quality of life. Analytical insights on clinical and patient-reported outcomes can provide a competitive advantage and support the case for reimbursement.
- Expand collaboration: The use of blockchain could make it easier to securely store and share clinical data—even among competitors. Blockchain is sort of a living, unalterable ledger of digital records. The technology can also be used to manage and track informed consent across multiple sites, systems, and protocols.
A comprehensive digital R&D strategy can be essential to process large amounts of data effectively, make business decisions quickly and accurately, and generate evidence that supports the development of future products. Many of the people we interviewed expressed a desire to be fast followers. Given the complexity of operationalizing a digital strategy, they also understand the risks in falling behind.