The Future of Clinical Trials: 5 Predictions From Industry Leaders

Key Takeaways
  • Decentralized clinical trials aren’t new, but the COVID-19 pandemic undeniably forced the research industry to adapt and adopt more decentralized practices, virtually overnight. 

  • Clinical-community linkages between clinical providers, community organizations, and public health agencies may become more commonplace in the effort to respond to a target population’s health needs more effectively.

  • There is a growing focus on patient centricity. DCTs help remove common barriers to patient enrollment, participation, and retention.

  • Behavioral science strategies can help researchers better understand what motivates people to take action or not when they are participating in a trial.

  • Strategic collaborations between organizations within the clinical research space can create a sum of parts that is greater than the contributions of the individual parts.

Clinical trials are at the heart of all medical advances that improve quality of life for patients across the globe. Researchers rely on these trials and the participation of volunteers to develop new ways to prevent, detect, or treat disease. Even when results deviate from predicted outcomes, information gained from clinical trials can help guide scientists in the right direction.[1]

For the past decade, clinical research has become increasingly decentralized thanks to new digital technologies and remote capabilities. This shift has been necessary, but even more so in light of COVID-19. The pandemic catalyzed the adoption of decentralized clinical trials (DCTs) while highlighting the critical benefits of virtual trials and improving the experience for both patients and physicians.[2]

After nearly two years, industry leaders met in-person at the 2021 Decentralized Trials and Research Alliance (DTRA) annual meeting to discuss key observations and celebrate successes that have taken place in the face of COVID-19. Vault Health was proud to share its most recent clinical research alongside Rutgers University and be part of the conversation around making patient-focused research accessible to everyone. Below are our key takeaways, which we believe will keep clinical trials at the heart of better health outcomes — more effectively.

DCTs Aren’t New, But There’s #NoGoingBack

Medical science has historically been slow to adopt new technology, but the pandemic changed attitudes and allocation to resources almost overnight. Over 1,200 clinical trials across the world were facing some kind of disruption, such as slow enrollment, suspension of registration, and delayed initiation of trials.[3] And we’re not just talking about COVID vaccine studies; time-sensitive oncology and hematology trials for cancer and blood disorders were impacted too. All eyes were on the clinical research industry to adapt and expand how it delivered patient care in a crisis.

And adapt, we did. Virtual and remote technology became the crux for everything from site selection, eligibility screening, electronic consent, telehealth, and data capture. Researchers, medical staff, sponsors, and sites enacted new procedures and processes that allowed patients to continue participating in clinical trials safely.

If there was any doubt before, these efforts during the pandemic proved that DCTs can yield better, safer, and faster health outcomes. And now that we know what is possible, leaders in the clinical research community are coming together in a social movement called #NoGoingBack. Pledging to this movement means that you 1) acknowledge the incredible progress that has been made in such a short amount of time, and 2) you are committed to continuing the momentum for improving clinical research. What innovation actually looks like is entirely up to the beholder. It could mean anything from providing a better patient experience through technology to developing new treatments for people across the globe. If you’re interested in joining the movement, you can pledge here.

Community Sites with Clinical Capabilities are Huge Assets

In the same spirit of adopting new technologies, expanding clinical capabilities is advantageous when it comes to improving the patient experience. In this context, a capability is any tool that enables research or research support. This includes, but is not limited to:

  • unique or specialized expertise
  • telemedicine
  • equipment that facilitates insights and innovation in clinical research
  • 24-hour care
  • digital patient tracking
  • dedicated programs
  • monitoring and education
  • a dedicated space for a subset of patients
  • network upgrade

A common theme we heard from other leaders at DTRA was that having clinical capabilities ultimately improved patient access, enrollment, and engagement during the COVID-19 pandemic. This isn’t surprising since DCTs inherently remove common barriers to participation, such as time, money, and transportation.

Clinical-community linkages can also play a pivotal role in improving the health of people and the communities in which they live. These linkages are strategic collaborations between clinical providers, community organizations, and public health agencies.

The goals of clinical-community linkages include:

  • coordinating healthcare delivery, public health, and community-based activities that are responsive to a target population’s needs
  • leveraging partnerships and varied expertise to fill gaps in needed services
  • to provide education and promote greater community involvement that will ultimately make public health programs more sustainable

Having clinical capabilities and the ability to link sites, whether virtual or physical, across the country, are huge assets — for both patients and physicians. When clinical and community sectors work together, they can improve care and support patients better than either of these sectors could do alone.[4]

Patient Enrollment is Slow — Accessibility, Diversity, and Inclusion Can Help

Globally, more than 80% of trials fail to enroll on time, and 55% of trials are completely terminated due to a low accrual rate.[5] Advances in medicine depend on volunteer study participation, so naturally, the research doesn’t happen without patients. This makes accessibility, diversity, and inclusion all the more important when it comes to recruitment.

In the traditional clinical trial model, patients have to travel to on-site locations for clinical treatments and observation, sometimes hours away from home — like taking time off of work, having transportation available, or a host of other inconveniences. Any of these factors can make study opportunities inaccessible to the individuals and communities that need them most. DCTs help remove these barriers by providing entirely virtual or hybrid care. Taking a patient-centric approach to medicine means that we can also reach people who live in clinical care deserts.

Enhancing clinical trial diversity is another moral and scientific imperative that leaders in the industry are actively working to solve.[6] Among the under-represented and under-studied populations include women, racial and ethnic minorities, children, and the elderly. This matters because different subgroups may present diseases at disproportionate rates or react differently to certain medical products.[7] Understanding the safety and efficacy of treatments across different populations can help reduce disparities and advance equity in healthcare for all.

Clinical researchers should be mindful that many of the same communities that lack access to traditional trials may also live in areas where there’s limited digital infrastructure. Patients in these particular communities might face challenges participating in DCTs that require a reliable internet connection or the use of digital devices. In the effort to diversify trials, researchers should look for opportunities to join forces with study sponsors that are able to provide potential patients with reliable, high-speed internet.

On the other side of digital literacy, youth often have a different set of expectations that could make or break their willingness to participate in clinical studies. Millennials and Gen Z have grown up using mobile solutions for everything from working, banking, shopping, and transportation. They not only rely on technology, they also expect it to work flawlessly. Clinical researchers wanting to study younger age groups should prioritize mobile solutions and technology that provide an enjoyable patient experience.

Behavioral Science Strategies Promote Higher Patient Engagement

Continuing with the theme of patient-centricity, behavioral science strategies can help researchers better understand what motivates people to take action or not. This is not a new concept; in fact, it has touched nearly every aspect of our lives over the past several decades, including the ads we see on television and the products we purchase. During the COVID pandemic, many research organizations adopted this practice using evidence-based interventions, or ”nudges,” to track patterns of human behavior related to participating in clinical studies.[8]

There are three core components of implementing behavioral science strategies and turning them into actionable opportunities:

  • Create Motivational Intervals – Setting milestones with rewards for patient action throughout the trial can help foster engagement, adherence, and retention.
  • Reduce Losses – Find the sources of lost time, money, and trust (the most common barriers for patient disengagement and drop offs). Decrease these losses by using virtual visits, reminders, passive data, content, and eConsent.
  • Embed Meaningful Goals – Give patients additional goals outside of the overall study milestones to make their progress trackable. Gamifying the experience or offering digital rewards that can be exchanged for real life rewards or experiences can further incentivize patients to take action.

We know that trial drop-outs can affect study costs, data collection, timelines, regulatory approval, and time-to-market for treatments. Taking a patient-centric approach to clinical trials and incorporating behavioral science strategies can help build a better patient experience, thereby improving engagement and retention.

Strategic Partnerships Are Powerful

With the industry increasingly focused on patient centricity, the need for partnerships that connect patients with research opportunities, and make it easier to participate, is greater than ever. And the reality is that collaborations between organizations within the clinical research space can create a sum of parts that is greater than the contributions of the individual parts. This includes labs, contract research organizations (CROs), patient advocacy groups, biotechnology and pharmaceutical companies, healthtech companies, as well as healthcare institutions and public health organizations.

Patients should also be regarded as active partners in clinical research. Once viewed as “subjects” with experiments performed on them, these individuals are now deeply involved in the design and planning of research protocols that contribute to clinical development. In order to empower patients and elevate their voice in future trials, researchers need to understand what patients value most. This can help inform what technologies are most appropriate, how to motivate patients, and develop treatments that will continue moving clinical research forward.

References

  1. Novitzke J. M. (2008). The significance of clinical trials. Journal of vascular and interventional neurology, 1(1), 31.
  2. No place like home? Stepping up the decentralization of clinical trials. (2021, July 28). McKinsey & Company. https://www.mckinsey.com/industries/life-sciences/our-insights/no-place-like-home-stepping-up-the-decentralization-of-clinical-trials
  3. Vara, V. (2021, March 2). Covid-19 pandemic disrupted more than 1,200 clinical trials: GlobalData. Pharmaceutical Technology. https://www.pharmaceutical-technology.com/surveys/covid-19-pandemic-disrupted-more-than-1200-clinical-trials-data/
  4. Centers for Disease Control and Prevention. (2016). Community-Clinical Linkages for the Prevention and Control of Chronic Diseases: A Practitioner’s Guide. https://www.cdc.gov/dhdsp/pubs/docs/ccl-practitioners-guide.pdf
  5. Desai M. (2020). Recruitment and retention of participants in clinical studies: Critical issues and challenges. Perspectives in clinical research, 11(2), 51–53. https://doi.org/10.4103/picr.PICR_6_20
  6. Gray, D. M., Nolan, T. S., Gregory, J., & Joseph, J. J. (2021). Diversity in clinical trials: an opportunity and imperative for community engagement. The Lancet Gastroenterology & Hepatology, 6(8), 605–607. https://doi.org/10.1016/s2468-1253(21)00228-4
  7. Office of the Commissioner. (2021, November 16). Clinical Trial Diversity. U.S. Food and Drug Administration. https://www.fda.gov/consumers/minority-health-and-health-equity/clinical-trial-diversity
  8. VanEpps, E. M., Volpp, K. G., & Halpern, S. D. (2016). A nudge toward participation: Improving clinical trial enrollment with behavioral economics. Science translational medicine, 8(348), 348fs13. https://doi.org/10.1126/scitranslmed.aaf0946

DISCLAIMER: This article is for general information purposes only, does not constitute medical advice and is not intended to be relied upon for medical diagnosis or treatment. If you are experiencing a medical emergency, dial 911 immediately.