By Adam Berman and Kelsey Jakee, PA Consulting
Clinical research has benefited from several advancements in recent decades. Expanding access to information has empowered patients to have greater autonomy in their care and a voice during the development process. Personalized medicine has given rise to promising new therapies treating smaller, more targeted populations. And the number of clinical trials leveraging virtual health tools and mobile technology is increasing. But seismic challenges still remain.
Despite society’s seeming “hyperawareness of everything,” clinical trials are still little known and largely misunderstood. Worrying gaps in knowledge still exist for diseases that affect high percentages of the global aging population, such as Alzheimer’s. Public and political attention is focused on the cost and value of medicine, placing increased pressure on industry to innovate for better, faster, and cheaper drug development.
Clinical research stands to benefit from bolder, large-scale transformation — further helping it fulfill its role of advancing medicine and creating a positive human future. With this in mind, we set out to answer a question: What could clinical trials look like in 10+ years and how will this impact the health ecosystem?
In building out our report, we spoke with a cross-section of thought leaders within the biopharma industry, as well as patient advocates, about the current challenges, predictions, and opportunities for clinical research and trials of the future — as well as the barriers to progress.
We heard from many respondents about the lack of awareness of trials and a broader understanding about their role in medicine and healthcare. One respondent told us industry is missing the boat on awareness for everyone — awareness that trials exist, that they are a care option, and that they can translate to new and better medicine. Research backs up this assertion. More than one in five (21 percent) of respondents to a survey by the Center for Information and Study on Clinical Research Participation rated how well they understood the term “clinical research study” (or “clinical trial”) as either “not at all well” or “not very well” (of those who had never participated). And this lack of understanding was spread relatively evenly across different age groups, with those reporting “not at all well” accounting for 3 percent in the 18 to 34 bracket and 2 percent in the 65+ bracket.
Yet, more than any single enabler, collaboration was cited most frequently by respondents as key to future progress in clinical research. Several told us that increased collaboration outside of organizational, geographical, and even sector boundaries will be instrumental to industry’s future success. There’s a recognition that innovation will come through greater sharing and participation in networks and consortia and a realization that cooperative transformation will further influence social awareness and understanding of trials.
All of this led us to three major conclusions about the future of clinical trials — we found that they would be open, human-centered, and integrated. We dive into those themes below.
1. Clinical Trials Will Be Open
Open clinical trials will involve connected infrastructure, consistent operations, and cooperative stakeholder involvement. A system in which trial operations are no longer a “black box” will break traditional silos between stakeholder groups and foster consistency and speed. Using a shared foundation and common elements to design and execute trials will ultimately dial down attention on process and free attention to focus on science and more rapid delivery of patient value. Elements of openness and collaboration in clinical trials can already be found in industry today, signaling progress that will continue to evolve over time as research stakeholders embrace greater systems thinking in their approach. For example, targeted efforts led by industry consortia such as TransCelerate BioPharma have resulted in the use of shared platforms for sites to interact across various sponsors and for sponsors to share placebo and control-arm data. The nonprofit Quantum Leap Healthcare Collaborative recently announced promising results of its I-SPY 2 trial, an adaptive platform trial involving several drugs across biopharma companies contained within a single master protocol.
The rise of shared, trusted research networks (such as ones led by consortia, nonprofits, or international governing bodies) will allow several stakeholders to tap into a common infrastructure to run and participate in trials. A more transparent system can build trust and increased willingness to cooperate across organizational and geographical boundaries. Commonly accepted best practices will minimize unnecessary distinctions between how Protocol A and Protocol B are executed. Algorithms may be used to accelerate initial protocol creation and study design, building data-driven logic into decisions that today are a mystery for many (such as restrictive eligibility criteria). Machine learning and advanced data sciences may also accelerate decisions on the progression of therapies through the development life cycle.
Industry will need to take care to avoid building too much automation into trial processes or decision-making. Human judgment will continue to be critical for ensuring continuous improvement, dynamic learning, and new innovations. Additionally, each trial and its intended patient population will involve nuance that only patients can help address. As Tammy Guld, global team lead at Janssen Clinical Innovation, comments: “Diseases can’t be fully understood by science alone. Development strategies must begin by hearing the story of the disease from patients first.” Research networks will provide a more structured pathway for sponsors to engage meaningfully with patients, caregivers, and others to inform study design and even research prioritization, building patient-led development directly into the infrastructure.
2. Clinical Trials Will Be Human-Centered
As open clinical trials enable greater focus on science and patient value, rather than operations, industry will further orient itself around the humans served by research. This will be a necessary shift — consumer expectations will rise and be shaped in a variety of ways by other industries, raising the bar on expectations for trial participation and clinical research more generally. Further advances in “omics” will tailor industry’s understanding of human biology and improve the capability to deliver targeted therapies. Companies will differentiate themselves based on the value provided to end users and trial participants, offering experiences that are personalized, seamless, and information-rich. Value will not simply mean a less burdensome experience for trial participants. In the future, trials will increasingly be organized around participants’ lifestyles, rather than around existing site or sponsor infrastructures.
With this attitude in place, additional focus will be on offering participants a richer, more engaging experience personalized to their unique needs and preferences. Participants will gain intuitive insights about their own health and care that they wouldn’t have had otherwise. The offering will become especially valuable when trials involve endpoints embraced widely across industry and regulators that are developed in partnership with patients, rather than by scientists alone. Approaching patients and trial participants as human beings with a wide variety of unique attitudes, desires, and lifestyle objectives will be an important shift in thinking.
The next decade will see continued empowerment of patients as individuals rather than as a cohort characterized by a medical diagnosis or set of symptoms. Those who participate in clinical trials will expect a more holistic and immersive experience, providing opportunities for continuous learning while receiving quality care. Personalized health reports, data visualizations, and portable raw data provided at the conclusion of a trial will provide participants the opportunity to carry forward their experience and power greater ownership over their health and care.
Building an informative and immersive experience will require striking the right balance between human and virtual interaction. Remote or decentralized trials, including those aided by wearable technology, are already on the rise. These approaches can enable patients to overcome logistic hurdles of participation and have already demonstrated promising improvements to enrollment. While virtual and hybrid trials become more common, this need not translate to less time with expert clinicians or other healthcare practitioners (HCPs) who contribute to the quality and attention of care. Virtual eConsent may be aided by live discussions with a care practitioner and interactive assessments to confirm understanding of important concepts. Uncomplicated labs may be performed at local pharmacies, using in-home specialists or even using self-service tools aided by same-day pickup. Digital connection to a participant’s care team and live, virtual visits can offer flexibility and tailored attention.
3. Clinical Trials Will Be More Integrated
As trials become more open and human-centered, society will have improved capacity to better understand and interact with clinical research. Trials can become more integrated in the medical system and perceived as a critical component of advancing health. Outcomes and learnings from trials can be applied more broadly and coherently with the purpose of helping to transform lives. Clinical trial networks can play a foundational role in embedding research and emerging science into healthcare, or “learning health systems.”
It should be noted, however, that the gap between our current state and a future when trials are better understood is not trivial. Today, there are more than 300,000 registered research studies across the globe, yet recent statistics indicate a large majority of the public has a limited understanding of clinical trials. Many clinical trials are situated at the intersection of science, for-profit motive, and human lives. Industry has an opportunity to rebrand the image of clinical trials in the most authentic way — as engines for discovering new, evidence-based therapies and tools for learning about one’s own health and the health advancements for generations to come. Industry will benefit from further educating the public about the rigor of the process and the quality of experience, but rebranding efforts will require more than basic education. Real-world stories and visibility into the actual lived experience of participating in a trial and its impact on empowering the individual will be crucial.
We believe that with the right action by the research community and former trial participants acting as ambassadors of research, clinical trials will reach a tipping point of perceived value and public interest. A groundswell of former trial participants, armed with their own data, may be more empowered to speak openly about their experiences — not as guinea pigs but as benefactors of a cutting-edge process of learning. While more people in the health system begin to speak the language of clinical research and trial networks connect to EHR systems, trials have the potential to become near ubiquitous in this setting.
Today’s fragmented health technology and points of care will increasingly tap into a shared network. Physicians and patients will regularly receive eligibility alerts in their EHR interface and patients’ collaborative care teams will include trial staff. Care pathways, automatically generated for shared decision-making between providers and patients, will expand to include trials as additional care options.
Takeaways For Biopharma Companies
So, what does this vision of the future mean for today’s researchers in the biopharmaceutical industry? It’s evident that adopting and applying a more open, human-centered, and integrated mind-set is essential to success in the next evolution of clinical trials. However, the respondents we spoke to identified culture and inertia as the largest overall barriers to progress. Preparing for the future of clinical trials — whether focused on a specific theme presented above or a combination of all three — requires action and leadership. While political, demographic, technological, and scientific factors will all determine the scope of change and the speed with which it arrives, opting to wait and see isn’t a viable option. We believe industry leaders will need to:
- Make tomorrow’s end consumer the focal point of their business, in some instances reversing traditional logic to understand their universe and anticipate future needs.
- Engineer innovation speed and agility into their organization to enable more rapid idea development through a think big, start small, and scale fast mind-set.
- Participate in cooperative, systemic transformation outside company walls to deliver on shared goals around technologies, operational methods, and disease understandings, as well as to benefit from greater transparency of learnings.
About The Authors:
Adam Berman is a life sciences expert at PA Consulting focused on helping clients design and deliver innovative strategies to accelerate product development programs. He brings a deep understanding of the product development life cycle and has worked with most of the top 20 pharmaceutical and biotech companies to implement new capabilities across the entire R&D value chain. Connect with him on LinkedIn.
Kelsey Jakee is a life science expert at PA Consulting. She is experienced in R&D strategy and transformation, patient-centered drug development, and operating model design. Connect with her on LinkedIn.