Professor Joel Lavine Explains How to Organize and Operate a Clinical Research Network

DEL MAR, CA / JULY 11, 2022 / Clinical research networks are collaborative groups of clinician-researchers that unify to locate and answer essential clinical questions. Dr. Joel Lavine is an academic physician-scientist who was the former Director of Liver Research at Boston Children’s Hospital and Harvard Medical School. He holds countless awards and accolades, including being the most cited Pediatric GI specialist in the United States.

Advantages of Research Networks

Dr. Lavine began by discussing the advantages of creating clinical research networks. A leading advantage is the diversity of the researchers involved. Clinicians from different backgrounds and locations bring unique ideas to studies, providing a broader perspective and expertise. The variety of researchers leads to the diversity of study questions and opportunities to study rare diseases. 

Organizing a Clinical Network

Joel Lavine, MD, Ph.D., explained organizing a clinical network is not an easy task. It requires numerous clinicians with expertise and willingness to offer the time and energy needed to find answers. Other organizational concerns include the availability of the subjects, the geographic distribution of researchers and subjects, the interaction of principals, the unique quality of the study, and the availability of center infrastructure. 

Creating a clinical network also involves tackling a variety of regulatory hurdles, including the FDA for IND, CRADA contracts, DCC site visits, external advisory boards, trial registration, and more. 

Budgeting a Clinical Network and Research

Budgeting is one of the most significant considerations when organizing a clinical network and performing research. Necessary budgeting considerations include budgets for patient care, investigator time, equipment, travel, data entry, coordinators, supplies, and numerous other elements. The network will also have to determine if payment is capitated or noncapitated. 

Operating a Clinical Network

Clinical networks enable change within the healthcare system. However, a clinical network must have effective leadership, functioning partnerships, and excellent communication to succeed. 

A variety of factors determine the effectiveness of a clinical network. Qualitative studies in 2016 showed how and why network operations function and what factors led to their success. 

The following are several factors contributing to the successful operation of clinical networks:

• Adequate resources, including funding
• Efficient management and credible leadership
• collaborative efforts and effective communication strategies
• trusting relationships among clinicians and patients
• strategically aligned and well-designed projects 
• quality partnerships, including those with professional organizations

A clinical network must include several committees, including steering, executive, database, pathology, radiology, imaging, ancillary studies, publication, and others. Each committee performs a role that works toward the success of the network and research. Role clarity and coordination are necessary to create an efficient and successful network.

Joel Lavine and Clinical Research Networks

Dr. Lavine worked with dozens of clinical research networks throughout the course of his career. He was the Vice-Chairman of Pediatrics Research at Columbia University for five years and Vice Chairman of Pediatrics faculty and fellow development at UCSD for eight years. Dr. Lavine was the most cited author at Columbia University in Children’s Health, according to Research Gate. 

Lavine’s research has altered the diagnosis, treatment, and outcomes of many diseases, including metabolic liver disease, pediatric cholestasis, viral hepatitis, and more.