The White House Clinical Trials Forum brought together key leaders in science, healthcare, and patient advocacy to address the pressing issues in clinical trials. The event, organized by the White House Office of Science and Technology Policy (OSTP), aimed to highlight innovative approaches to make clinical trials more inclusive and accessible to all Americans.

The director of the OSTP emphasized that despite being one of the wealthiest countries, the U.S. faces unacceptable health inequities, with dozens of countries boasting longer life expectancies. The need for inclusive clinical trials that reflect the country’s diverse population to develop effective interventions was highlighted. Here’s a comprehensive overview of the forum’s discussions and the significant takeaways from The White House Clinical Trials Forum.

Innovation in Clinical Trials: Perspectives from Experts

The White House Clinical Trials Forum featured a medical oncologist who moderated the first panel on people-centered clinical trial innovation. Experts included the national coordinator for health IT and the director of ARPA-H

Progress in Digitizing Healthcare Records

The healthcare system has undergone a significant transformation over the past decade. Ten to twelve years ago, only about 5% of provider organizations used electronic medical records (EMRs). Today, 97% of hospitals and 80% of physician offices use certified electronic health records (EHRs). This shift from paper-based to digital systems has laid the groundwork for more advanced data utilization in healthcare, particularly in clinical trials.

Standardized APIs and Nationwide Network Interoperability

The Department of Health and Human Services (HHS) recently finalized a rule related to the 21st Century Cures Act, which prohibits information blocking to enhance this interoperability further. This rule mandates that provider organizations, technology developers, and health information networks must share all electronic health information with authorized parties, including for research purposes. This regulatory change aims to break down barriers that previously hindered data sharing, ensuring that essential patient information is available when needed.

The national coordinator emphasized that the healthcare industry is finally beginning to “discover the internet” using digital tools and policies to improve patient care and research. The ongoing efforts to create a nationwide interoperability network, the Trusted Exchange Framework and Common Agreement (TEFCA), will further enhance these capabilities. TEFCA, which went live in December, includes major EHR vendors and aims to create a scalable and efficient means of sharing health information across the country.

Enhancing Patient Access and Engagement

The advancements in health IT also empower patients by giving them more control over their health data. Patients can now access their medical records on smartphones and share their information with healthcare providers or researchers. This patient-centric approach is critical for enhancing participation in clinical trials, as it reduces the administrative burden on patients and ensures their data is readily available.

Laying the Groundwork for AI and Advanced Data Analysis

The digitization and interoperability of healthcare data also set the stage for more advanced technologies, such as artificial intelligence (AI) and machine learning. These technologies can analyze large datasets to identify patterns and make predictions, which can be invaluable in clinical trials.

These advancements in health IT are crucial for future clinical trials, enabling faster, more efficient, and more inclusive research. These technologies’ continued development and implementation will be vital to improving health outcomes and advancing medical science.

Improving Access and Participation

The second panel, at The White House Clinical Trials Forum, moderated by the deputy assistant to the president for the cancer moonshot, focused on improving clinical trial access and participation. Panelists included Dr. Robert Califf, commissioner of the FDA, the director of the NIH, and a patient advocate.

The patient advocate shared her experience as an eight-year cancer survivor who has participated in multiple clinical trials. She highlighted patients’ financial and logistical challenges when enrolling in clinical trials, emphasizing the need for more accessible, patient-centered approaches.

For example, she discussed the high costs of traveling to trial sites, as many trials are conducted at major academic centers far from rural or underserved communities. She also pointed out the time burden, as participating in a trial often requires frequent visits to these centers, which can be challenging for individuals who must take time off work or arrange childcare.

Additionally, the patient advocate underscored the importance of simplifying the enrollment process. She noted that the extensive paperwork and preliminary tests required can be overwhelming and deter participation. Streamlining these processes and offering more support to patients could significantly enhance enrollment rates.

Dr. Robert Califf and the FDA’s Diversity Action Plan

Dr. Robert Califf announced the release of a new draft diversity action plan guidance to increase diverse participation in clinical trials. This initiative is critical, as historically, clinical trials have often lacked diversity, leading to a lack of data on how treatments affect various populations differently.

The draft guidance calls for more comprehensive planning by pharmaceutical companies and researchers to ensure that trial participants reflect the demographics of the broader population. This includes considering race, ethnicity, age, and gender in trial designs.

Dr. Califf stressed the importance of clinicians in encouraging patient participation. He highlighted that participation rates improve when doctors and nurses actively inform and inspire patients about clinical trial opportunities. This underscores the need for healthcare providers to be well-informed about ongoing trials and effectively communicate their potential benefits to patients.

NIH’s Care for Health Initiative

The NIH director introduced the Care for Health initiative, a groundbreaking effort to bring clinical trials to underserved communities by integrating research with primary care. This initiative addresses the significant disparities in health outcomes observed across different regions and demographics in the United States.

The initiative focuses on establishing enduring partnerships with primary care providers in communities with exceptional needs, such as rural areas or regions with high rates of chronic diseases. By embedding clinical trials within primary care settings, the initiative aims to make participation more accessible to patients who might otherwise be unable to travel to distant academic centers.

Additionally, the Care for Health initiative emphasizes the importance of tailoring research to meet the specific needs of each community. This approach recognizes that health challenges and priorities can vary widely across populations. By allowing communities to select the most relevant research, the NIH aims to ensure that the outcomes of these trials are directly applicable to the populations they serve.

The initiative also supports primary care providers by offering resources and training to conduct research. This helps improve patient care and builds a sustainable infrastructure for ongoing research within these communities. Over time, this could significantly improve health outcomes as new treatments and prevention strategies are developed and tested in real-world settings.

The Path Forward

The White House Clinical Trials Forum concluded with a call to action. Participants were encouraged to continue collaborating and innovating to ensure clinical trials are accessible, inclusive, and reflective of the diverse U.S. population. The vision is clear: to build a healthcare system where clinical trials are a standard, equitable part of patient care, leading to better health outcomes for all Americans.

As the discussions and collaborations continue, the hope is that the initiatives and innovations shared at the White House Clinical Trials Forum will pave the way for a more inclusive and effective healthcare system.