New England Research Institutes (NERI) is a key partner in a recent $23.4 million grant from the National Institutes of Health to Boston University that funds the Boston University Clinical and Translational Science Institute to train and support scientists conducting cutting-edge clinical research. The aim of the Institute is to stimulate “translational science,” which is the process of turning laboratory discoveries into new treatments, new diagnostics, and improved public health.

NERI will be participating in this exciting Program in several ways. It will be part of a local study unit called the Multi-site Research Implementation Control Unit (MR-ICU), to facilitate start-up and implementation of multi-site trials from the National Center for Advancing Translational Sciences at NIH. NERI was selected to join because of its practical experience in conducting trials, expertise in regulatory, contracting/budgeting, quality assurance, and site support. NERI also has an extensive database of more than 200 trial sites throughout the US and around the world.

In addition, NERI will be helping BU CTSI team members address a significant problem in conducting clinical research: slow or inadequate recruitment into trials. In many trials, the time between approval to begin recruiting and the first person actually enrolled takes several months. The goal is to reduce this time to 30 days. NERI will provide training and access to its clinical databases to help achieve this ambitious target.

“We are charged to grease the wheels of a very slow and cumbersome national clinical trials network,” says David Center, who has directed the BU-CTSI since 2008. “We aim to shorten the Institutional Review Board [IRB] process and to assist in the efficient enrollment and retention of subjects in trials and in all the steps along the way, from identification of the need for the trial to data analysis.”

Another way NERI will be engaged in the translational sciences effort is by hosting scholars and scientists in “mini sabbaticals.” These short-term programs (up to 3 months long) will encourage the injection of new ideas and approaches into member institutions’ research and ignite team members’ professional growth.

“We are helping to enhance team science training by developing new opportunities for scholars to participate together to solve problems both in seminars and in funded research,” says Sonja McKinlay, president of NERI and lead scientist on the BU grant.

NERI staff will be serving as expert mentors on the grant to help ensure that research protocols will be conducted in the same way at all of the clinical sites in the consortium. The team is currently drafting an inventory of the training programs that are currently provided to investigators in their networks. They will then select the best examples of each type of training and develop methods for delivering that to our on-site and off-site investigators. NERI has the most sophisticated site-monitoring program among the off-site affiliates and it will serve as the model for the program.

“Our affiliation with NERI will allow us to enhance our existing strong capabilities in biostatistics, data and research management, particularly with their clinical site monitoring network,” Center says.

About NERI

NERI is a global, privately-held specialty Contract Research Organization providing customized clinical trial solutions and patient registry services to pharmaceutical, biotechnology, biomaterial and medical device companies. NERI also has extensive experience collaborating on federally-funded research with organizations like the National Institutes of Health. Since its founding in 1986, NERI has earned widespread recognition for its scientific credibility, efficiency, and expertise in conducting clinical trials in a variety of medical specialties. For more information, visit www.neriscience.com.

About BU

Originally established in 1848 as the New England Female Medical College, and incorporated into Boston University in 1873, Boston University School of Medicine (BUSM) today is a leading academic medical center with an enrollment of more than 700 medical students and 950 students pursuing degrees in graduate medical sciences. BUSM faculty contribute to more than 668 active grants and contracts, with total anticipated awards valued at more than $693 million in amyloidosis, arthritis, cardiovascular disease, cancer, infectious diseases, pulmonary disease and dermatology, among other areas. The School’s teaching affiliates include Boston Medical Center, its primary teaching hospital, the Boston VA Healthcare System, Kaiser Permanente in northern California, as well as Boston HealthNet, a network of 15 community health centers. For more information, please visit http://www.bumc.bu.edu/busm/