Digital Tech Transforms Clinical Trial Successes
Even though biopharma companies have been very successful in bringing many breakthrough treatments to market in the last decade, the current R&D model is unsustainable, thanks to notoriously high risks, low ROI, and high costs.
And it isn’t improving.
In fact, a Deloitte analysis of return on pharmaceutical R&D investments for 12 large biopharmaceutical companies shows a steady decline from 2010 to 2017, with returns dropping from 10.1% to 3.2%. Talk of digital R&D at clinical operations conferences has been gaining momentum in the industry as a possible means of turning these numbers around.
Recently, the Deloitte Center for Health Solutions interviewed over 40 industry stakeholders to discover the barriers of using digital technologies in clinical trials, understand why the pace of digital adoption is relatively slow, and to explore where the industry sees value for using digital tech in the clinical development process. The collected information did not disappoint.
Digital R&D and the Patient Experience
Clinical trials are by and large behind the times when it comes to implementing digital technology; many of them still use 1990s-era processes, and many R&D functions haven’t yet fully leveraged genomics information, real-world evidence, and emerging data sources like wearables, mobile apps, and the Internet of Things (IoT).
But what’s the big deal?
The big deal is that digital tech can have the power to completely upgrade the way biopharma companies execute, engage, and innovate during trial processes by addressing pain points that investigators, trial staff, and sponsors face. These pain points include those impacting patient identification, recruitment, and retention through the entire life of the trial.
With the advancement of digital tech across markets on a global scale, the expectations patients carry evolve; they demand a more personal, more inclusive trial experience. Digital technologies can grant them a better experience and support patient-centric objectives by redefining how patient care is carried out during trials and making participation less burdensome overall. This, in turn, improves the entire trial.
How Digital Tech Can Improve Patient Engagement and Trial Success
- Digital Tech Means Fewer Test Subjects and More Collaborators
Biopharma companies could learn far more from trial participants by treating them less like subjects and more like collaborators. Seek out their inputs on issues like getting past research mistrust; address patient-specific concerns related to the design of the study. Clinical teams who are embracing digital R&D are using tech to measure patient-centric endpoints, including the ability to perform specific daily tasks and overall quality of life. They then incorporate feedback into the trial process by way of things like focus groups, crowdsourcing, study pilots, and online surveys. In addition, patient feedback on the trial experience should be used to shape the final treatment.
- Digital Tech can Expedite Patient Recruitment and Increase Diversity
It’s become increasingly difficult to recruit patients for clinical trials; in fact, 15-20% of trials never enroll a single patient and 66% fail to reach original enrollment goals. Enrolling participants who reflect real-world patient cohorts is a problem, as well. In the U.S., only 10% of participants are non-white, even though it is known that factors like gender and ethnicity can impact drug efficacy. Digital tech can reduce the cost and effort required to diversify and recruit populations; technology-aided approaches include advertising on online patient communities, websites, social media, and through mining unstructured patient data.
- Digital Tools Improve Trial Patient Care and Treatment Adherence
Self-reporting is still the main means of measuring patient adherence. Blood tests can also validate self-reported data, but they aren’t always affordable or even practical. Digital technologies can increase treatment adherence and patient care throughout the entire trial; for example, smartphone apps and automated texts can remind patients to take their medications, provide answers to patients’ questions, make scheduling visits easier, and facilitate recording health data. Digital tools that use facial recognition can also confirm the administration of medication and generate reports of non-adherence to appropriate investigators, as well.
- Digital Tech Makes Participation More Convenient
Traveling for trials can be a significant burden for many participants. On average, 70% of potential trial participants in the U.S. live over two hours away from the nearest study center. This negatively impacts not only their willingness to participate, but also their ability to do so. Virtual trials can enable patients to participate from their own homes for much of the duration of trials, reducing or even eliminating the cost and inconvenience of participation. Using e-consent, telemedicine, mobile apps, social media, and biosensors to support data collection and communication is key. Results from remote patient monitoring are comparable, and in some cases superior, to in-clinic assessments because remote monitoring provides a continuous picture of a patients progression.
The rewards of digitizing clinical R&D can be significant, even though adoption can be complex, lengthy, and resource intensive. Digital tech can dramatically lower costs, increase effectiveness and accuracy, and improve the patient experience through the entire trial development process. It can also increase the amount and quality of the data that is collected. Finally, digital tech can enable faster cycle times for products in development, as well.
Interested in learning more about the advantages of digital tech adoption in the clinical R&D process? Reserve your seat at an upcoming clinical operations conference and gain an advantage from the latest developments in clinical digital technology.