Major contract research organizations (CROs) and leading investigative site networks are jockeying to attain competitive advantage by establishing stronger relationships with academic health systems. Such relationships may offer unprecedented access to not only large professional and patient communities, but also substantial operating infrastructure at a time when convergence between healthcare and clinical research is intensifying.
A look at the world’s largest and most active academic research organization (ARO), the Duke Clinical Research Institute (DCRI), provides insights into key success factors for players pursuing that strategy. Those insights include maintaining independence and objectivity while actively engaging in open collaborations, carefully and purposefully integrating progressive practices and technology solutions, and focusing first and foremost on the needs of the patient and healthcare provider communities.
DCRI has annual revenues that are in excess of $200 million, a third of which is federally- and foundation-funded. It is supported by a staff of 1,200 employees and a global network of 5,000 investigators in more than 65 countries. The ARO has completed more than 970 phase I-IV clinical trials involving more than 1.2 million patients, along with outcomes studies and comparative effectiveness analysis since its inception in 1996. It also manages registries comprised of more than a million patients and either has managed or monitored six mega-trials. Although DCRI has conducted clinical trials in multiple therapeutic areas, more than 60% of its trials target cardiovascular illnesses.
“We broadened the scope of trials and outcomes research based on what people were interested in and where there was a need and always with the patient in mind,” said Lisa Berdan, senior director of global megatrials and an executive committee member who has been at DCRI since 1990.
“The success of this organization is a combination of teamwork and collaboration across people and positions with the visionary leadership of Dr. Robert Califf, who had the ability to identify the key clinical research questions and inspire people to help him get answers to those questions,” said Berdan.
Growth by open collaboration
Califf, a prominent cardiologist who has spent years developing new clinical trial designs for medicines against blood clots, gained significant attention when he and co-Principal Investigator Eric Topol led the first GUSTO trial in the early 1990s. GUSTO was an influential study that helped Genentech establish one of the first major biotechnology drugs, tPA (alteplase). The trial also established the precedent of independent investigators acting freely without interference from the sponsor, which helped establish a new standard for the conduct of clinical trials. Califf used the infrastructure from the GUSTO trial to create DCRI as one of the first alternate and independent AROs separate from the purely commercial operations run by the pharmaceutical industry or outside companies.
DCRI’s senior management has continued to drive its growth by relying on open innovation models bridging connections across stakeholder groups within the clinical research enterprise. Califf led the key clinical trial evaluating Johnson & Johnson’s blood thinner Xarelto, which the FDA approved in 2011 to prevent strokes in people with an irregular heartbeat. Xarelto now generates more than $1.5 billion in sales annually, according to IMS.
To preserve DCRI’s neutrality and independence, Califf and his senior colleagues have taken the high road: No companies can review or approve manuscripts written by DCRI. Today, about 63% of DCRI’s research funding comes from industry and 37% from government organizations, notably the NIH.
In 2007, DCRI received funding from the FDA to form the Clinical Trials Transformation Initiative (CTTI)—a public-private partnership, now with more than 60 member organizations, that focuses on identifying and promoting practices to improve clinical research quality and efficiency.
Califf sees collaboration with a wide range of people as the route to improving patient care, according to Berdan. “We trusted him, and he trusted us and our industry partners, always looking for better patient care and the future, such as using electronic health records and working with our pharmaceutical partners,” she said.
“He also saw the importance of improving local healthcare here in Durham (N.C.) and was quick to point out that we live and take care of our neighbors, as well as the rest of the world overseas. The model he created is based on having a clinical champion with a passion to drive the growth of therapeutics through electronic health records, and improving technology to make trials more patient-centric. Trial methodology is booming here at the DCRI and it cuts across all therapeutic areas,” explained Berdan.
Earlier in 2015, Califf left DCRI to become one of the FDA’s deputy commissioners. He was recently recommended to be named the new FDA commissioner—he would succeed Dr. Margaret Hamburg, whose resignation took effect in March.
Progressive yet pragmatic
DCRI recently received a $144 million grant to study the impact of environmental exposure on child health and development. Researchers at four medical centers will leverage several pediatric data collection networks to test tools that assess children’s physical, psychological and social health, along with quality of family life and peer relationships.
“Our view of outcomes research is to ensure that the trials are representative of the population of patients we treat,” said Adrian Hernandez, M.D., DCRI’s head of outcomes research. “We also make sure to do pragmatic studies in the flow of care and always drive toward answers for patients to make sure that what we are doing is used for the development of a drug or device. We are addressing questions, not just study design but using the analytic methods to get studies done more efficiently and closer to the real world.”
One major example, he noted, will start next year with the launch of a large study comparing low and high dosages of aspirin used in secondary prevention of cardiovascular events in high-risk patients. The online public health study will involve 20,000 people through seven regional networks across the country using electronic health records and patient engagement. It is the first major study from the National Patient-Centered Clinical Research Network (PCORnet). Hernandez said it is designed to overcome the difficulties that make medical research expensive, inefficient and slow to provide results.
At its Innovation Center, DCRI is looking to incorporate novel clinical designs with real-world registries and endpoints using the Apple ResearchKit, wearables, sensors and other technologies. Also a priority at the Innovation Center: reducing protocol complexity, promoting better use of electronic health records and collecting data and information from patients in real time.
“Using a combination of electronic capabilities, we can create a ‘soup-to-nuts’ in clinical design and execution of capabilities, which is becoming the hallmark of DCRI,” said Zubin Eapan, M.D., assistant professor of medicine at Duke School of Medicine and faculty lead for the DCRI Innovation Center.
“There is always room for improvement at DCRI. It still needs to find enough people for specific jobs and participate in additional collaborative efforts,” noted Berdan.
Eapan said there were some initial studies where integration of clinical trials into health systems “were a bit early in their development, but we have always learned something and made the next clinical trial better.”
“We affectionately call DCRI the mother house as it relates to academic research organizations,” said Paul Armstrong, M.D., professor of medicine at the University of Alberta, Canada, and a director of the Canadian VIGOUR (Virtual Coordinating Centre for Global Collaborative Cardiovascular Research), another ARO.
“Califf and his team learn as they go. They’ve developed the talent, depth, breadth and commitment to high-quality research. At other academic research centers, people are worried about stealing ideas and sharing of data, but at DCRI there’s more than enough for everybody with a spirit to pitch in, learn and glean things from clinical trials that help patients and design better projects in the future. I’ve often said our ARO in Canada is like the corner store and DCRI is the Wal-Mart,” added Armstrong.
Ronald Rosenberg is a former business and science reporter for The Boston Globe. He has written features for New Scientist and Inc. magazine. His lengthy journalism career includes editing an award-winning weekly newspaper in Cornwall, N.Y. Ron also was a media relations specialist for the science faculty at Boston University, and a Knight Science Journalism Fellow at the Massachusetts Institute of Technology.
This article was reprinted from Volume 22, Issue 11, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. Subscribe >>