Building a New Generation of Clinical Trials, Together

Clinical trials serve as the bridge between scientific innovation and medical progress. Despite their importance, only about 5% of people in the U.S. have participated in a clinical trial1 — underscoring the urgent need to build greater awareness of their value and to eliminate barriers to participation. For clinical trial sites, operational complexity and administrative burden are increasing, while clinical trial participants face obstacles that hinder their involvement. These challenges widen the gap between scientific discovery and real-world impact. But with the right focus and collaboration, we have an opportunity to strengthen this bridge and create a system that benefits all those involved.

The Weight of Clinical Trial Complexity

Across the healthcare industry, there is a recognition that the growing complexity of clinical research poses significant challenges to drug development. Research from the Tufts Center for the Study of Drug Development (CSDD) shows the tangible impacts of protocol complexity. For investigators and sites, every additional procedure adds operational strain, time and workload. For clinical trial participants, this complexity can mean more visits, longer timelines for participation and greater effort to stay enrolled.

These findings provide clarity and highlight the need for transformative action. By leveraging these insights, we can move from acknowledging the problem to implementing solutions. The goal is clear: to design and deliver clinical trials that are simpler, more efficient and more accessible. Importantly, this is more than an aspiration; we already have the tools and capabilities to make this transformation a reality. 

A Path to More Practical Research

To accelerate medical progress, clinical trials must work for all stakeholders: investigators, sites and participants. Achieving this requires balancing scientific rigor with practical design, so research is efficient and sustainable for those on the front lines. Key to achieving this balance are three priorities:

• Grounding decisions in data: Leveraging data from diverse, real-world sources can help ensure clinical trials reflect needs of the patients for whom an investigational therapy is being developed. Insights from Tufts CSDD illustrate how protocol design decisions influence timelines and operational complexity. Incorporating these insights can help sponsors develop clinical trials that are more efficient to conduct. 

• Incorporating participant and site feedback: Engaging participants and clinical trial teams early in the process and often can help clarify the factors that drive — or hinder — participation. Sponsors can use this feedback to streamline protocols, reduce non-critical procedures and design studies that fit more naturally into routine clinical care.

• Using technology as an enabler, not a replacement: AI, automation and digital tools can reduce administrative burden and streamline operations. By freeing up human capital, the integration of new, innovative technology allows clinical teams to focus their time and expertise where it matters most. 

Together, these approaches can help enable a more resilient clinical research ecosystem that aligns with the realities of modern health care. 

Empowerment Through Awareness and Education

For clinical trials to truly evolve, participants and healthcare professionals must view them as an integral part of care rather than a last resort. Unfortunately, many patients remain unaware of clinical trials or are uncertain about their role in advancing medicine. Others may feel intimidated, or unsure of where to find information about participation. 

However, those who do take part often share a different perspective. A Regeneron survey revealed that most people who participated in a clinical trial would participate again or would recommend others do so. Their top motivator: the desire to help save and improve lives.

Clinical trial sponsors have an important role in shaping this awareness. At Regeneron, initiatives like the “What’s Your Legacy?” campaign celebrate the role of investigators and participants. By emphasizing the human impact of clinical trials, such efforts can transform perceptions and lead to more empowered medical decision making. 

Creating Progress Together

Enhancing the clinical trial experience for participants, investigators and research sites requires collective effort. No single company or organization can solve these challenges alone. Progress depends on shared accountability, open dialogue and coordinated action across the healthcare ecosystem. Each stakeholder has a unique role to play:

• Pharma & life sciences: Continue to collaborate to establish clinical research standards, share insights and reduce barriers. Lead efforts to educate the public about the value of clinical trials. 

• Sites & investigators: Provide sponsors with critical insights into the key drivers of complexity that slow recruitment and retention. 

• Providers & health systems: Integrate trial opportunities in everyday care conversations when appropriate. 

• Patients & advocates: Offer feedback to ensure trial designs and experiences are realistic, supportive and tailored to real needs. 

• Policy makers & regulators: Adapt frameworks to accommodate innovation while maintaining trust and safety. 

The future of clinical trials is one where participation is easier, protocols are streamlined, and research becomes a natural extension of care. Now is the time to act — to share insights, contribute solutions and move forward as a unified community dedicated to advancing medical progress. Together, we can usher in a new era of clinical trials that will shape the future of medicine and improve patient outcomes worldwide. 

Reference:

1. Jiang S, Hong YA. Clinical trial participation in America: The roles of eHealth engagement and patient-provider communication. Digit Health. 2021;7:20552076211067658. Published 2021 Dec 14. doi:10.1177/20552076211067658.