“We all need somebody to lean on,” wrote singer-songwriter Bill Withers in 1972. His wise advice is especially appropriate for scientists on the long, tricky road of translational and clinical research. The team of people behind Dartmouth SYNERGY, the Dartmouth Clinical and Translational Science Institute, are providing that kind of support for junior biomedical scientists committed to improving patients’ health. SYNERGY helps junior researchers take their biomedical research findings and leverage them into new treatments for patients through a huge range of research tools and clinical research support.
One major piece of support is SYNERGY’s Clinical Research Unit (CRU). The CRU provides a “structure for high quality research that protects the safety of patients and also educates the junior researchers of tomorrow,” says William Rigby, MD, director of the CRU and a professor of medicine at the Geisel School of Medicine. The unit offers investigators, especially those early in their career, a range of important services to help conduct clinical trials. These include preparing and shipping samples, space to work with patients, education on how to handle the immense paperwork (writing informed consents, working with the institutional review board), and the services of research nurses, a research manager, and study coordinator. Using the CRU is like using a travel agent to book a trip. “You can have somebody just book the rooms for you, book the flights for you, or they can provide the whole package. You just show up and we take you from point A to point B,” says Rigby. The CRU has a review board—consisting of SYNERGY leadership and faculty investigators—that oversees CRU’s activities and ensures that patient safety and other professional standards are met.
A key mission of Dartmouth SYNERGY, the Dartmouth Clinical and Translational Science Institute, is to foster discovery and innovation in translational and clinical research.
Clinical research is designed for direct advancement of patient care; it often involves testing a drug to see how effective it is in treating a certain disorder and comparing that drug to another drug or a placebo. Translational research is further upstream in biomedical research. “You’re trying to ask a question about a disease or how a drug may work and you have a hypothesis you wish to test that may be more relevant to the disease or its particular biology,” says William Rigby, MD, director of the SYNERGY CRU. Translational research is work that is steered towards developing new treatments for a disease.
SYNERGY has grown rapidly since it was first launched in 2010. A major part of its funding is through a highly competitive Clinical and Translational Science Award (CTSA), received by Dartmouth in 2013.
Since it opened in October 2012, SYNERGY’s CRU now supports 83 studies (both patient clinical trials and laboratory processing studies); 40 investigators currently use the CRU across 18 sections of Dartmouth-Hitchcock, including gastroenterology, rheumatology, dermatology, and pulmonology. Dermatology has especially benefited. Prior to the CRU, they had one research nurse who managed everything from “regulatory startup all the way through to study completion including seeing all of the patients,” says Debra Rodgers, the CRU’s operations manager. Dermatology managed four studies at a time. Now the CRU provides dermatology with a nurse, research coordinator, and administrative support and their research output has exploded. As of fall 2014, they are running 11 clinical trials. “That collaboration has allowed for the streamlining and more efficient use of the physicians’ time,” says Rodgers. The CRU’s team includes partners in other areas of Dartmouth-Hitchcock including DH’s Imaging CRU and Center for Surgical Innovation, as well as clinical researchers at the White River V.A. Medical Center.
Shane Chapman, MD, section chief of dermatology, has worked with the CRU for many of these trials (he and his team have completed 35 clinical trials at DHMC since 1999). A lot of the medications he studies, especially for skin cancer, are “life-changing,” he says, “and it turns out they’re actually very safe.” Clinical trials are very useful, says Chapman, because it is an opportunity for him to learn early on about a drug’s safety and effectiveness, even before the drug may become FDA approved.
“There are a lot of advantages academically to be doing clinical trials and talking about them, and speaking from your own experience rather than from someone else’s data,” he says.
Chapman did initial trials at Dartmouth of the drug Otezla for psoriasis; the drug was later approved by the FDA in September 2014. Chapman is now working with the CRU on a trial using the same drug, Otezla, to treat atopic dermatitis.
“My goal in doing clinical trials is I want to know if [the drug] works. I don’t want the company telling me that is works or how well it works, or what the side effects are or how common they are,” he adds. “I would rather talk about different medical products to my colleagues for studies that I’ve done, firsthand experience before they’re FDA approved,” he says.
The CRU has filled an “enormous amount of services that have gone wanting in the last few years,” says Rigby. “In the old model, everybody had their own clinical research units in their departments. That has really imploded and we’re providing space, energy, resources, and skill for all those things. Even to the simplest thing of shipping out samples [for analysis]. Shipping out samples is a huge effort.” A major goal moving forward is to expand the CRU’s services to the southern New Hampshire region by creating a partner CRU in Manchester, N.H. Researchers will then be able to conduct their trials in both Lebanon and Manchester, creating more clinical opportunities for patients and reducing travel time for patients and investigators.
“The whole point of the CRU is that it only works as long as you’ve got a great team providing really great service,” Rigby adds. “So fortunately we’ve got a great team.”