Kearney, Neb., April 19, 2018 — The Bridging Clinical Research & Clinical Health Care Collaborative, a strategic forum to strengthen the connection between clinical research and clinical health care, brought together leaders from pharma, biotech, clinical research organizations, health care organizations, advocacy groups and the FDA on April 4–5. With active participation and problem-solving, the forum stimulated collaborative solutions to the multifaceted challenges of improving patient and physician participation in clinical research and making clinical research a clinical care option.
The event’s three pillars — regulatory, technology, and people and processes — featured more than 50 speakers over 15 interactive sessions. Collaborative Chair Badhri Srinivasan, ABD, MS, head of global development operations at Novartis, launched the event by urging attendees to embrace advances in clinical research while reducing the complexity in protocol, processes and access that burdens patients.
Keynote speaker Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, proposed initiatives to build the bridge between the dysfunctional clinical research enterprise and clinical health care. For all stakeholders, the focus needs to shift to collaborative learning and the rapid sharing of information gained from research. Patients and community practitioners must be brought back into the enterprise, rather than marginalized by complex science and a lack of data sharing.
Technological advances such as eConsent, mHealth, the Internet of Things, the cloud, artificial intelligence and machine learning, and blockchain can both improve patient engagement and simplify clinical trial workflows. Speakers also discussed how electronic health records (EHRs) represent a data goldmine that can be leveraged toward learning health systems, where stakeholders learn and improve as a result of every experience of every participant. The key to creating a single solution is to leverage data to simplify workflows to understand both patient populations and sites across geographic areas.
Clinical trial participant and a keynote speaker T.J. Sharpe shared his personal perspective, bringing emotion to the event and reminding attendees of the need to make clinical trials a valid clinical care option for everyone. “I was able to bridge those gaps. I can tell you that many others don’t, can’t or won’t do that. And they deserve a chance to live, just like I did,” he said.
Throughout the people and processes session, participants reiterated the patient’s central role. Because patients are scarce, clinical trials should be designed not for or around them, but with them. The patient ultimately makes the treatment path decision. To simplify access and provide complete transparency, it is necessary to look for existing principal investigators in planned studies that are part of health systems, and health systems’ marketing strategic investments need to expand.
“We need to bridge clinical research and clinical care to patients. If both of those enterprises connect to patients, they will connect to each other,” said keynote speaker Greg Simon, JD, president of the Biden Cancer Initiative. “Participation in the collaborative is a critical step in strategizing and implementing solutions that ultimately bridge patients to clinical care and research.”