Clinical Trials

Clinical Trials at New Jersey’s Healthcare Institutions

Discover how hospitals are partnering with drug companies in order to provide patients with cutting-edge medications and treatments.

Garden State hospitals are discovering state-of-the-art ways to prevent, diagnose and treat diseases and conditions ranging from cancer to high blood pressure by partnering with pharmaceutical and biotech companies to host clinical trials.

“The fundamental purpose of clinical trials is discovering how we can improve the outcomes that matter most to patients, particularly when the standard of care doesn’t result in a cure, such as cancer, or when managing a chronic disease like diabetes,” explains Robert C. Garrett, co-CEO of Hackensack Meridian Health, where one current clinical trial is focusing on the use of CAR T-Cell immunotherapy to treat cancer.

The healthcare network recently established the Center for Discovery and Innovation (CDI), a state-of-the art facility that offers researchers the support they need to develop novel therapies for some of the world’s most challenging diseases, including cancer, diabetes, dementia, antibiotic-resistant infection, and auto-immune disorders. “Our new center will transform the treatment of patients by integrating our extensive clinical expertise and research contributions with ongoing basic and translational research,” explains Dr. Andrew Pecora, former president of physician services and chief innovation officer at Hackensack Meridian Health. (Pecora was recently named CEO of Outcomes Matter Innovations, LLC)

To that end, John Theurer Cancer Center, part of Hackensack University Medical Center, announced in May that it’s joining the National Cancer Institute (NCI)-recognized Georgetown Lombardi Comprehensive Cancer Center Consortium (GTLCCC) to advance research and innovate treatment. “We’re committed to innovation across all aspects of health and healthcare, including how we research, treat and cure cancer,” Garrett says.

The only NCI-designated comprehensive cancer center in the state, the Rutgers Cancer Institute of New Jersey, is currently involved in some 100 clinical trials, and has forged partnerships with global, international and national firms in its efforts to remain on the forefront of cancer research. “Clinical trials have always been an important part of our institution, so we have a long track record of working with almost every major pharmaceutical and biotech company,” says Dr. Howard S. Hochster, associate director for clinical research and director of gastrointestinal oncology at Rutgers Cancer Institute of New Jersey and director of oncology research at RWJBarnabas Health.

Dr. Hochster explains that clinical trials typically fall into three categories: industry-sponsored trials, investigator-initiated trials, and NIH-sponsored trials. “Because we don’t cure as many people with cancer as we would like, clinical trials should be the standard for most patients who are eligible,” he asserts.

Choosing New Jersey Hospitals for Clinical Trials

When it comes to choosing a healthcare network to host a clinical trial, one of the most important factors in the decision-making process is turnaround time. Saint Peter’s University Hospital aims for a clinical trial activation timeline of two months by relying on central Institutional Review Boards (IRBs) and adherence to workflows that focus on efficiency and accountability. Saint Peter’s research program operates more than 200 clinical trials supported by pharmaceutical companies at both the national and international levels, including drug and device interventions as well as studies evaluating diagnostic testing.

According to Dr. Niranjan Rao, chief medical officer at Saint Peter’s, the hospital collaborates with pharmaceutical companies, government-sponsored programs, academic medical centers, and private physician practices to host clinical trials. The desire to host clinical trials is also a key reason why the state’s healthcare networks are striving to employ preeminent clinicians. “There’s a propensity for high-performing clinicians to be actively engaged in clinical trials, and they require the resources of a research program to support their efforts,” explains Alex Schramm, director of the office of research at Saint Peter’s University Hospital.

Hackensack Meridian operates under a 90-day rule when it comes to opening trials, and has built partnerships with life science and biotech companies to get trials to open faster. “Participating in clinical trials – and having the infrastructure these companies need – allows us to bring patients tomorrow’s medicine today,” Garrett says. “Patients who come to us are receiving treatments that will be given five to seven years from today at other healthcare institutions.”

At Valley Health System, Dr. Suneet Mittal was recently a member of the steering committee and site principal investigator for the WRAP-IT trial. The landmark clinical trial evaluated the ability of a novel, absorbable antibacterial envelope to reduce infections associated with cardiac implantable electronic devices (CIEDs). “The No. 1 benefit for Valley’s participation in clinical trials is improving patient care,” asserts Taja Ferguson, director of research for Valley Health System, whose research portfolio runs the gamut of: industry-sponsored trials with examples including AstraZeneca, Boston Scientific, Medtronics; federal, such as with the NCI and National Heart Lung and Blood Institute (NHLBI); and local, with firms such as Becton Dickinson (BD).

Hackensack Meridian Health’s CDI is home to experts including Dr. Roger C. Kornberg, a Nobel laureate and chemist revolutionizing modern genetics and molecular biology; Dr. David S. Perlin, former executive director of the Rutgers New Jersey Medical School’s Public Health Research Institute and former director of the Rutgers Regional Biocontainment Laboratory; and Dr. David S. Siegel, founding director of the center’s Institute for Multiple Myeloma.

Current Clinical Trials

At Saint Barnabas Medical Center, one clinical trial is aiming to help patients living with high blood pressure. “High blood pressure is one of the greatest threats to patients globally, including New Jersey residents,” says Dr. Sabino Torre, director of cardiac catheterization labs at Saint Barnabas Medical Center and a member of Barnabas Health Medical Group. In collaboration with the cardiac research and clinical trial coordination team at Newark Beth Israel Medical Center, the clinical study is investigating a medical device that will help lower blood pressure and determine the safety and efficacy of renal denervation on blood pressure using an investigational radiofrequency energy delivery catheter and generator.

Englewood Health is currently working with a pharmaceutical sponsor to evaluate a new investigational drug as a potential new treatment for patients with ulcerative colitis. It is also participating in an NCI-cooperative group trial studying the effects of weight loss on the incidence of breast cancer recurrence, and collaborating on a study to determine the best outcome between two different vascular surgery options.

“The path to improved patient outcomes is through research. Clinical trials generate the data needed to advance our medical knowledge and develop the next generation of treatments,” says Jamie Ketas, vice president of quality at Englewood Health. “As part of our commitment to providing state-of-the-art patient care, we incorporate investigational treatment options through participation in clinical trials.”

Funding Clinical Trials

While the benefits of clinical trials for the future of healthcare seem limitless, there’s always the question of how this research will be funded. Jillian Hoopes, Virtua Health System’s director of research administration, explains that when a hospital or healthcare network is approached by a company, it will devise a contract and budget to cover costs so that anything research-related is taken care of by the company, and the care always remains free to the patient.

Ferguson notes that although there’s a federal law requiring most health insurance plans to cover routine patient care costs in clinical trials under certain conditions, they aren’t required to cover the research costs of a clinical trial. However, most sponsors will cover research costs as well as travel costs for additional doctor visits. “Clinical trials aren’t typically seen as a revenue generating source. They’re more of a long-term investment,” she explains. “Over time, research has contributed to an efficient and effective healthcare delivery system, which can be recognized as a financial benefit for Valley and our patients.”

Patient Safety

When it comes to clinical trials, patient safety is always of the utmost importance. As such, federal agencies at both the state and national levels play a crucial role in protecting human subjects. “The safety and efficacy of the study treatment are tracked through the same standard of care testing and monitoring that would be done if the patient were receiving a routine treatment,” Ketas explains.

Every clinical trial in the US must be approved and monitored by an Institutional Review Board (IRB), an independent administrative body that protects the rights and welfare of patients participating in clinical trials. According to Schramm, the Department of Health and Human Services (DHHS) maintains oversight of clinical research through two agencies, the Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP). “Clinical trials, when performed under the regulations set forth by the FDA and OHRP, ensure the transparency of the results and an assurance of the consistent standards and conditions in which they were achieved,” he adds.

There are also internal reviews within each healthcare network that exist to help ensure patient safety. “Most hospitals believe in patient-centered care, and thus we have internal checks and balances and an internal review process and auditing committee that’s always watching to ensure we’re protecting patients and following protocols – and the sponsor of the trial will also do their own audits,” explains AnnMarie Palatnik, assistant vice president of clinical learning for Virtua.

Of course, in addition to protecting human subjects, the state’s healthcare networks also have to ensure they are legally protected. Dr. Hochster explains that before any patient goes into a clinical trial, they sign an informed consent document that explains the risks and benefits of the trial and the rights of the patient. Additionally, the hospital itself shouldn’t face any issues as long as it follows the necessary protocols and conducts the trial as it’s intended.

“We’re proud to be able to offer these opportunities to patients within our community,” Hoopes says, noting that many of Virtua’s current trials are targeted towards improving patients’ quality of life. “I think people sometimes underestimate what can result from a clinical trial. It may not always be a brand new drug, but instead a new formulation that could mean taking medication only once or twice a day instead of every four hours … and these advancements make a huge difference in the lives of our patients.”


Healthcare Efficiency – NJ’s Progress Toward High-Value Care

By Sean Hopkins, Senior Vice President, Center for Health Analytics, Research & Transformation, NJHA

Hospitals remain the largest cost component of the healthcare system and, as such, have been under constant pressure to provide care more efficiently.

The New Jersey Hospital Association’s Center for Health Analytics, Research & Transformation (CHART) analyzed New Jersey hospital data from 2006 and 2016 to measure the magnitude of improvement in the efficiency of hospital care delivery achieved.

Per National Health Expenditure Data, health expenses nationally in 2017 accounted for 17.9% of Gross Domestic Product (GDP). With healthcare spending expected to grow faster than GDP from 2018-2027, costs related to healthcare will rise to 19.4% of GDP in 2027.

Hospitals have been a target for controlling cost growth. The percent of national health expenditures in 2017 for hospital services was 32.7%.

Hospitals in New Jersey have spent the better part of the last decade shifting services from the costlier inpatient setting to the less costly outpatient setting, making a commitment to provide the right care with the right provider in the right setting.

In 2006, the total number of inpatient admissions to New Jersey’s acute care hospitals was 1,139,228. That number decreased by 14% in 2016, with inpatient admissions falling to 979,099. This reduction took place even though New Jersey’s population increased by 3.7% over that same time period. Additionally, the average length of stay (ALOS) at New Jersey’s acute care hospitals declined from 2006 to 2016.

When more, less sick patients are treated outside the inpatient setting, what is left in the hospital inpatient setting is a more complex case mix.

In 2006, the average complexity score for inpatient services across all New Jersey hospitals was 1.4987. In 2016, that index jumped to 1.7370. This represents a 16% increase in the average inpatient complexity at a New Jersey hospital. When the New Jersey ALOS from each year is neutralized for the differences in complexity, hospitals produced a real reduction of 20.4% over 10 years. This compares favorably to the national reduction of just 13.6%.

The sustained increase in healthcare spending has been the subject of discussion and scrutiny by government officials, policymakers and providers as they grapple with bending the cost curve. As the rate of growth in healthcare spending in the United States outpaces the growth in GDP, the pressure on providers to become more efficient care deliverers will remain.

New Jersey hospitals have received that message and have acted to improve the efficiency of the patient care they deliver.

For the full report and resources, visit www.njha.com/CHART.

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