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After the excitement of discovery, clinical trials bring science to the community

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Story - Clinical Trials Research nurse coordinator Carol Ciccarelli, RN, prepares Peter Lavallee of Northbridge for a clinical trial of an infusion drug for diabetes.

It’s a long way from the scientist’s “eureka” moment to the physician’s prescription pad, and necessarily so. Every biomedical  development brought to bear on human health must first progress through rigorous and heavily regulated clinical trials—meeting standards of safety, demonstrating efficacy and proving therapeutic benefit—before making its way into use. Clinical trials, which to patients can sometimes seem frustratingly long and slow, are critical to the bench-to-bedside process; without them, untested new medications and procedures could potentially cause great harm in patients.

Being selected by the National Institutes of Health for a $20 million Clinical and Translational Science Award means UMass Medical School joins an elite consortium of 55 institutions charged with accelerating the pace of clinical research and more quickly bringing safe and effective therapeutics to patients. UMMS has been laying the groundwork for increasing the size and scope of its clinical research enterprise through infrastructure enhancements, collaboration with clinical partner UMass Memorial Health Care and a new Clinical Research Center (CRC), all of which position the institution for quick action.

With UMass Memorial, UMMS faculty already enroll patients in 800 to 900 open human studies each year; of those, about 250 to 300 are intervention trials measuring the therapeutic effect of a medical procedure or pharmaceutical. Other types of trials underway include medical device testing (often comparing a standard device to one that has been altered or enhanced), observational studies or healthy volunteer studies. Many of the intervention trials conducted by UMass principal investigators are externally sponsored multisite trials—with UMMS contributing patient data and documentation but not analyzing the data or drawing conclusions—but faculty are increasingly designing, conducting and analyzing their own trials.

The CTSA gives UMMS the resources to do more—and more complicated—trials in the hospital setting, such as a comparison study of surgical devices or a 12-hour infusion study in which the dosage of a new chemotherapy agent is being tested. “Any new device or medication carries with it some risk,” said Sheila B. Noone, PhD, assistant vice provost for clinical research, who has been involved in the Medical School’s methodical efforts to build its clinical trials capabilities and win the five-year CTSA grant. “In some cases, a hospital setting provides peace of mind and additional ‘just-in-case’ safeguards. We’re fortunate to have an excellent tertiary care center as our clinical partner.”

Strategic plans call for doubling the capacity of the current Clinical Trials Unit (CTU), an outpatient center located on the seventh floor of the Medical School building where specially trained research nurse coordinators manage the hands-on needs of clinical trials, such as collecting blood samples or delivering medications and providing careful and consistent documentation for PIs. In addition to the CTU, the new CRC on the first floor of the soon-to-be-opened Ambulatory Care Center (ACC) will have six exam rooms and three infusion bays in which to conduct studies, as well as additional research nurse coordinators and other staff.

To some degree, the growth of the institution’s clinical trials portfolio will hinge on the community. Clinical trials require the availability of a large pool of everyday people and patients willing to take part in clinical research and clinical trials as volunteer study participants. Many clinical studies recruit patients who suffer from the disorder being studied, but there is an increasing need for healthy people in phase 1 trials.

“When you stop and think about it, every patient who benefits from a medication or a diagnostic test or a minimally invasive procedure owes a debt of gratitude to the participants of the clinical trials that made that medication or test or procedure possible,” said Dr. Noone, who is preparing to build a communication campaign to engage the community and raise public awareness about what participation in a clinical trial entails. Toward that end, the front door of community access to clinical trials will be the new Clinical Research Center soon to open on the first-floor of the ACC, adjacent to the lobby. There, patients and visitors alike can obtain information about open trials and current recruitment needs.

Concurrent with public outreach efforts are internal efforts to pilot an electronic system tying together numerous components of the clinical research arm—from the Institutional Review Board to the Human Subjects Committee to the Institutional Animal Care and Use Committee, along with grants and contracts—allowing real-time tracking of study status, from grant proposal through patient recruitment to publication.

In addition, the Medical School has also been laying the groundwork for accreditation as a Human Research Protection Program (HRPP)—the gold standard, Noone said, for clinical studies programs. “It’s a rigorous review of the systems we have in place—protocols, policies, cross checks and safeguards—for conducting studies that are as efficient, safe and ethical as possible,” said Noone. “It raises the bar and says a lot about the organization’s commitment to its study volunteers. We owe it to our volunteers for all they do to help us advance medical care.”