Making human trials work

Certificate course prepares clinical research managers for success

By Sandra Gray

UMass Medical School Communications

April 22, 2011
noone article 
  Carol Bova, PhD and Sheila Noone, PhD

In their quest to discover medical breakthroughs, researchers rely on clinical research studies with human subjects. But a principal investigator (PI) with a great idea for an investigation, and the funding to pursue it, is only the beginning of a successful clinical trial. Assessing the feasibility of a study’s design, assuring legal and ethical integrity while enrolling subjects and managing data that yields usable results are all essential elements of a successful clinical trial. In addition to the PI, these responsibilities are often undertaken by other professionals on the research team, who must navigate the many logistical aspects of implementing a study. Seeking more in-depth knowledge and advanced understanding of what issues must be addressed in order for a clinical trial to be a success, 13 such individuals signed up as charter members of the new Clinical Research Management (CRM) Certificate program at UMass Medical School. 

“Our goal in creating this program is to develop an experienced workforce that considers all aspects of clinical research, including data management, feasibility and ethical considerations, to name just a few,” said Sheila Noone, PhD, assistant vice provost for clinical research and assistant professor of obstetrics & gynecology. “Our first class represents the exact target we had in mind, including management level research nurses and coordinators, data coordinators and regulatory staff.” 

Along with Dr. Noone, who has institution-wide responsibility for the oversight of clinical research practice, clinical study agreements, training and education and the Institutional Review Board (IRB) at UMMS, Carol Bova, PhD, associate professor of nursing and medicine, co-directs the CRM course. Also a member of the IRB, Dr. Bova conducts National Institutes of Health (NIH) funded clinical investigations. “We understand that clinical trial managers and coordinators are the front line for the safety of human subjects in clinical trials,” she said. 

Bova and Noone experienced the complexity of clinical trials with human subjects firsthand when they originally worked together in the 1980s as nurses on the front lines of the HIV/AIDS epidemic, administering trials of the experimental drugs that have since turned HIV infection from a death sentence to a manageable chronic condition. “Back then there was no formal training,” recalled Bova. Now, 25 years later, they are delighted to have the resources to share their and others’ knowledge with the clinical research managers who are following in their footsteps. 

With the award last summer of a prestigious five-year, $20-million Clinical and Translational Science Award (CTSA) grant, the NIH recognized the outstanding research already being conducted at UMass and its clinical partner, UMass Memorial Health Care. Launched in 2006, the CTSA program supports critical infrastructure for clinical and translational science at top academic medical centers. With the award supporting establishment of the system-wide University of Massachusetts Center for Clinical and Translational Science (CCTS) at UMMS (see sidebar), the scope of clinical research undertaken by the Medical School and UMass Memorial will evolve to a whole new level. “There is an institutional advantage to having high-level clinical research management personnel who will drive and shape our ability to conduct increasingly sophisticated investigations,” said Bova. 

Funded by the CCTS and offering continuing education credits for participants seeking the knowledge, skills and attitudes required to function at a senior level of clinical research management, the CRM certificate course comprises four modules covered during eight classes with a blended approach of web-based readings, assignments and on-site seminars. Case studies give students a chance, individually and in teams, to address critical issues for safe and ethical research practice. The text that Noone and 

Bova selected, Principals and Practice of Clinical Research, reflects the complex, multi-faceted nature of the field, with sections addressing no fewer than 27 critical considerations for clinical research managers who, in many respects, are the face of the principal investigator whose study they are managing. 

The inaugural CRM Certificate class brings together nurses, scientists and other clinical research staff from a broad range of disciplines, including cardiology, surgery, gene therapy, infectious diseases and pediatric immunology. One of them, UMass Memorial research nurse Karen Berni-Giarusso, RN, was drawn by the course’s advanced level. “Understanding the feasibility of protocols will help us pick studies with a better chance of completion and success,” she explained. “This class discusses these issues and supports what we are doing.” Berni-Giarusso, who has been involved with clinical trials for more than ten years, first in the Department of Medicine, now in the Department of Surgery, and whose oversight currently includes studies of cardiovascular aortic aneurysm grafts, kidney transplants, pancreatic cancer markers and traumatic brain injuries, appreciates the varied perspectives of guest faculty and classmates alike. “I love the discussions, the speakers have been great, and Carol and Sheila both have a wealth of knowledge to share with us.” 

“Participation in potentially risk-laden trials is a gift from a subject that needs to be honored by the institution and its staff,” said Noone. “Our subjects deserve our competence and care.” 

“We want to give credit and support to those who do this complex work.” added Bova. “We’re excited that we’ve already had many calls for the next session.” 

The UMass Center for Clinical and Translational Science 

The recently established University of Massachusetts Center for Clinical and Translational Science (CCTS) serves as the home for clinical and translational scientists and research across all five UMass campuses. The CCTS is supported by a prestigious five-year, $20-million Clinical and Translational Science Award (CTSA) from the National Institutes of Health that places UMass Medical School in an elite group of 55 prominent medical research institutions working together as a national consortium to improve the way biomedical research is conducted across the country. Along with consortium partners, the CCTS shares a common vision to shorten the time it takes for laboratory discoveries to become treatments for patients; engage communities in clinical research; and train a new generation of researchers. 

Related links: 

Certificate in Clinical Research Management 
Clinical and Translational Science Award 
University of Massachusetts Center for Clinical and Translational Science