Summary: 2019 Bridging Clinical Research & Clinical Health Care Collaborative

Since 2018, the Bridging Clinical Research & Clinical Health Care Collaborative has brought together patients, advocacy groups, biopharmaceutical companies, clinical research organizations, hospitals, regulators, technology companies, and others to discuss how to improve participation in clinical research and eliminate the chasm that divides research and care.

SCORR Marketing, the organization behind the Bridging event, is collaborating with the Conference Forum on the 2020 Clinical Research as a Care Option (CRAACO) conference. Bringing these initiatives together ensures that the entire spectrum of discussions needed to put patients at the center of research and care are entertaining more diverse viewpoints and supporting action, all in one event.

CRAACO will be April 27–28, 2020, in Raleigh-Durham, N.C. SCORR will be the event’s lead media sponsor.

Summary of three major themes that occurred during discussions:

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“Frankly, this is probably our industry’s most important topic and conference – the industry just doesn’t realize it yet.”

John Barry, MBA
Chief Operating Officer
Pharm-Olam

Patients and Patient-Centricity

Patients as partners in research was an important focus. Research data presented at the Collaborative showed that patient perceptions and attitudes toward clinical research differ by condition and demographics — indicating that taking a single approach to encourage patient participation may not be effective. Patients are motivated by a variety of factors, and the industry needs to consider these motivators when designing and communicating about research.

Incorporating patient feedback and preferences has been supported by FDA-led, patient-focused drug development (PFDD) meetings and is intended to capture patients’ experiences, perspectives, needs, and priorities to guide drug development. This approach is being continued with externally led PFDDs and coordinated by advocacy groups, to continue to inform research and medicine and medical device design to meet the needs of patients with specific conditions. These initiatives play an important role in advancing research to benefit patients by basing design on what patients need.

In addition, in a survey of Collaborative attendees, many reported they incorporate the patient voice through traditional methods such as partnering with advocacy groups and conducting patient interviews, focus groups, and surveys.

Top Two Benefits of Learning Health Systems for Patients:

  • Health care professionals will provide more informed care and research options
  • More informed care and improved health outcomes

Integrating patients’ preferences and advocacy groups into research processes can help companies design and improve clinical studies. Additionally, techniques such as direct-to-patient and virtual and hybrid studies were discussed as potential solutions to reach more patients by making it easier for patients to participate in research. Several companies mentioned using patient burden scores to improve the patient experience.

Technology was discussed as an important element for supporting patient-centric initiatives based on larger datasets. The use of artificial intelligence to gather data about patient preferences for medicines, medical devices, clinical outcomes, and education needs, when combined with behavioral insights, can inform product and research protocol design for end users. Through the use of real-world data, researchers and health professionals can get a better understanding of patients’ day-to-day lives and what motivates them; with that information, it is hoped that we can improve strategies and produce better health outcomes.

The Power of Patient Data

It is clear that patients must be the priority in both research and health care; however, we must also consider the power we can gain when we leverage their data.

First, this data can drive efficiencies: Patient health data in a digital format such as an electronic health record (EHR) can assist with recruiting, establishing enrollment criteria, assessing trial feasibility, and selecting sites — and, ultimately, reducing costs and accelerating development of new treatments to patients.

Second, de-identified patient data can improve clinical care. When patient data can be analyzed across a hospital, a practice, a region, or by therapeutic area, physicians build their knowledge by evaluating what treatments, procedures, and support are most effective and produce the best outcomes for patients. De-identified patient data can also be used for regulatory purposes such as continued risk assessments and drug safety and quality oversight. However, to leverage the inherent power of patient data, clinical trial data systems and EHR systems must have standard formats to enable information to be consolidated for analysis. Recognizing how critical this is to the future of research, the FDA provided an update during the Collaborative on its end-to-end strategy for creating data standards.

However, more is needed. To maximize the value of patient data, especially as it relates to global clinical studies and health, global data standards will need to be established and harmonized with data from a variety of external sources like the literature, benefit claims, social media, and digital behaviors.

Integrating research and patient data into a learning health system

In a survey of Collaborative attendees, ensuring patients learn about research as a care option was cited as a primary challenge.

And, patients do, in fact, want to improve their health literacy — and learn more about clinical research. Seventy-seven percent want the industry to make it easier to learn about clinical trials, 70% wish findings from clinical trials were more readily available, and 66% would like clearer information about the costs of participating, according to research presented at the Collaborative.

Two Biggest Industry Challenges in Strengthening the Connection Between Research and Health Care to Realize a Learning Health System:

  • Ensuring that all patients learn about research as a care option
  • Harmonizing global standards for EHRs and clinical research

Advocacy groups can play an important role in providing educational resources to patients. However, in addition to patient education, there are other bottlenecks that reduce the speed of drug development.

One well-known problem is patient recruitment. It is estimated that 11% of initiated investigative sites in Phase II and III clinical trials will fail to enroll a single patient (1). While there are a variety of reasons for this, the failure to reach physicians, interest them in research, and support them during a trial is a major concern.

11%

of initiated investigative sites in Phase II and III clinical trials will fail to enroll a single patient

Administrative burden, time-consuming tasks, unreimbursed work, difficulties finding appropriate patients, and lack of knowledge of available clinical trials and how to access them are all significant challenges faced by doctors and other health care professionals — and a major reason why we have been unable to integrate research and care. Building clinical trial infrastructure into a physician’s office is one approach being taken by research companies to support physicians and address some of the challenges related to connecting research and care.

Several presentations at the Collaborative explored other strategies for reinventing clinical research. Converting patient data to knowledge is no easy task, but the Collaborative allowed us to learn from experts how these concepts have been applied with demonstration projects in Japan, Europe, Serbia, China, and the United States.

Conclusion

In summary, the varied presentations and stimulating group discussions at the Bridging Collaborative included diverse perspectives from stakeholders, visionaries, and thought leaders across the clinical research spectrum. While everyone was excited about the possibilities of what can be achieved with the new ideas, technologies, research, products, and services presented, the Collaborative gave attendees the opportunity to zero in on the people at the center of research: the patients.

In addition to the key themes discussed, a few speakers challenged the Collaborative with yet bigger ideas. They questioned whether the industry has fallen in love with the problems and challenges associated with the current paradigm, in which we develop products, technologies, and services to essentially plug every gap. As an alternative, should we rethink the entire process?

“We have plenty of solutions that address plenty of problems. Are we thinking about this as solutions or [should we be] thinking about this as platforms?…A platform allows us to build an ecosystem that ever advances, that is ever increasing.”

Badhri Srinivasan, ABD, MS
Head of Global Development Operations
Novartis

Particularly over the past 30 years of clinical research, the world has changed: from technology and digital advances and the ensuing cultural shifts in the way people communicate, to the emergence of health care systems and globalization, to precision medicine and innovative scientific discoveries. Do we need to rethink the process to address new global health imperatives? Do we need to look at solving problems with a platform solution rather than with many individual solutions?

How we answer these questions carries great ramifications for the future of clinical research. Let’s be sure we keep asking the questions and seeking the answers.

(1) Applied Clinical Trials, The Need and Opportunity for a New Paradigm in Clinical Trial Execution, June 01, 2018, Kenneth Getz, Volume 27, Issue 6. http://www.appliedclinicaltrialsonline.com/need-and-opportunity-new-paradigm-clinical-trial-execution