Industry & Partners

Hartford HealthCare is committed to improving the lives of cancer patients through value-based research and education. Progress is represented by increased participation in clinical studies examining therapies, supportive care and screening.

Our honed focus is on outcomes, improving quality care, reducing health disparities, immuno-oncology, and integrating cutting-edge technology and treatment options.

Our research commitment overlays multi-disciplinary disease management teams and standards of care. The program is enriched by a collaborative partnership with Memorial Sloan Kettering centered on bi-directional learning for research and implementation science.

Examples include a new, comprehensive Phase 1 program offering novel therapeutics for patients with late-stage disease, a molecular tumor board guiding clinical decision-making based on genomic indicators, and improvements to the delivery of cancer care in medically underserved communities through our receipt of the Stavros Niarchos Foundation award through the ASCO Quality Improvement grant. We continue to optimize research by reducing barriers and administrative burdens while maximizing use of existing technology.

Our primary focus is offering our communities clinical research studies faster and more efficiently.


The Hartford HealthCare Cancer Institute (HHCCI) includes cancer centers at seven hospitals across Connecticut and 16 owned and operated cancer care clinics. HHCCI programs treat more than 6,000 new cancer patients and tens of thousands of existing patients each year, with multidisciplinary disease management teams offering a full range of innovative, evidence-based and personalized treatments.

Our structure, impact and reach

HHCCI is organized around disease areas, applying best practices system-wide so patients receive the highest standard of care close to home. Our physicians and research team rotate through practice sites, also providing cutting-edge treatment with equal quality and expertise.

Support

A Central Clinical Research Office

Our physician-investigators are supported by a dedicated Central Clinical Research Office (CCRO), a shared resource with highly-trained research staff. CCRO units have expertise in such areas as: clinical coordination, research nursing, informatics, regulatory expertise, fiscal management, training and education, protocol development, research laboratory, research informatics and quality assurance.

The CCRO – which is comprised of experienced clinical research professionals like certified oncology research nurses (OCN) and ACRP/SoCRA-certified clinical research coordinators - operates under a shared service model that draws on nimble structure and staffing elasticity so resources can quickly shift according to volume needs, allowing execution of “just-in time” models of care.

Approximately 145 studies are open to IRB at any given time, with 50 open to enrollment consistently.

Key Partnerships

MSK Cancer Alliance

HHCCI is a charter member of the Memorial Sloan Kettering (MSK) Cancer Alliance, a transformative initiative designed to collaboratively guide community providers toward state-of-the-art cancer care. Our membership includes a rigorous resourcing and capabilities assessment by MSK.

The Alliance is rooted on three pillars:

  1. Alignment of practice-changing standards of care
  2. Access to clinical research
  3. Bi-directional education

The MSK Cancer Alliance is a transformative initiative designed to improve the quality of cancer care and the lives of people with cancer by bringing evidence-based, world-class standards of care to community healthcare providers. The Alliance accelerates integration of the latest advances in cancer care into community settings and, as a charter member, an increasing number of leading-edge MSK cancer clinical trials and protocols are now available to patients receiving care through HHCCI.

Alliance goals include:

  • Foster the rapid adoption of MSK standards of care and the integration of the latest treatment advances in the community setting
  • Expand access to MSK’s clinical trials and cutting-edge cancer research
  • Improve the quality of care and outcomes for cancer patients both in the community and at MSK in a measurable way
  • Encourage learning and integrated collaboration among physicians and health professionals across all member institutions and MSK

More about the MSK Cancer Alliance


Jackson Laboratory Research Institute

Our translational partner is The Jackson Laboratory (JAX), a world leader in genomics research and distinguished NCI-designated program. JAX brings advanced genomic technologies to bear on persistent cancer problems through collaborative partnerships with our clinical investigators. We partner to interrogate cancer in clinically meaningful ways. Many of our clinical investigators have joint appointments, shared grants and investigator-initiated studies with JAX scientists. Together, we are able to move discoveries from bench to bedside.

Memberships

The National Clinical Trials Network (NCTN)

The National Clinical Trials Network (NCTN), supported by the National Cancer Institute (NCI), has played an integral role in cancer research over the past 50 years. The primary goal of NCTN research is to conduct definitive, randomized, late-phase clinical treatment trials to help establish new standards of care, set the stage for FDA approval of new therapies and validate new biomarkers. Nearly half of NCTN studies do just that. A retrospective cohort study evaluating 182 Phase III NCTN trials involving 148,028 patients from 1980 to 2017 concluded that 45 percent led to guideline care (NCCN) or new drug indications with positive and negative findings1.

Hartford HealthCare is a long-standing NCTN member dating to the early 1980s through NRG Oncology. Several of our physicians serve on committees and in key leadership roles within NCTN, representing our research program and HCCCI at the national level. This visibility adds legitimacy to our program, brings new opportunities and connects us with practice-changing science.

Our membership is evaluated routinely based on physician engagement and service at the national level, data quality and enrollment to clinical trials.

1JAMA Netw Open. 2019 Sep 4;2(9):e1910593.

HHCCI was an early adopter of the TransCelerate Shared Investigator Platform, which facilitates interaction between investigators and multiple clinical trial sponsors to enhance efficiency, reduce administrative burden and hasten trial activation.

We are listed under Hartford HealthCare Cancer Institute at the organizational level. All investigators associated with the organization delegate feasibility survey and credentialing management to the CRO.

Early Phase Research Program

The HHCCI Cancer Innovation Clinic provides personalized care for advanced and complex cancers.

The clinical team collaborates to perform in-depth genetic and immunological testing to develop cutting-edge treatment strategies that might include gene-targeted and immune-based therapies and provide opportunities to participate in promising early phase clinical trials.

Expertise

Our early phase program team is led by a group of nationally-renowned physician researchers, supported by a multidisciplinary team that includes medical oncologists, oncology pharmacists, oncology-certified nurses, nurse practitioner/physician assistants, a dedicated research nurse practitioner, nurse navigator, pathology and molecular biologists, financial counselor, social worker and clinical trial specialists.

State-of-the-art facility

Our Phase I Cancer Innovation Unit is a 1,650-square-foot facility adjacent to the inpatient oncology unit. The Unit offers ICU-level patient care rooms for up to seven patients, patient/family lounge and adjoining biomarker laboratory for rapid specimen processing. Headed by Dr. Omar Eton, the Unit has seven full-time staff and extensive experience in adaptive design, including participation in the NCI Alliance basket trials. In addition, the team has several genomic-directed clinical trials and a comprehensive experimental therapeutics program focused on precision medicine and immunotherapy research in advanced solid tumors and malignant hematology.

Recruitment and reach

Through our network of 16 owned and operated cancer care clinics across Connecticut, HHCCI treats more than 6,000 new cancer patients each year. This large volume means we can recruit patients to meet clinical trial accrual targets. Clinical research is a focal point of our community engagement and outreach efforts. Monthly HHCCI newsletters list ongoing trials and e-blasts reach more than 500 community oncologists, providing easy access to active clinical trials through targeted web presence, clinical trial awareness materials and discussion at tumor boards. We also conduct comprehensive pre-screening of all new consultations for potential trial matching.

Innovation

HHCCI also participates in the MSK-IMPACTTM (Integrated Mutation Profiling of Actionable Cancer Targets), a 468-gene sequencing platform panel that offers targeted all patients tumor-sequencing so they can be matched with targeted agents based on their tumor’s molecular profile. MSK-IMPACTTM is the first laboratory-developed tumor-profiling test with FDA authorization.

Quality

In 2020, we established the Quality Assurance and Education Program to ensure protocol adherence and data monitoring and facilitate audit preparation. Program staff conduct regular internal quality reviews of case, regulatory and pharmacy records and facilitated several external audits across multiple studies, all resulting in acceptable outcomes. Through the Program, a centralized secondary eligibility verification system ensures protocol compliance and patient safety, specifically in complex early phase clinical trials.

Resources & Capabilities

Study Activation

To hasten trial activation, contract and budget processes are conducted in parallel with scientific and IRB review. Our centralized contract office team is responsible for legal language, with approximately 30 master agreements on file to expedite negotiations. We also utilize an e-signature process via DocuSign® to eliminate administrative burden and decrease time required for wet ink signatures. We can provide desired terms in advance as a standard template to streamline the process.

The CCRO provides financial specialists who work on new clinical trials. We perform a comprehensive coverage analysis to determine items or services considered standard of care, followed by a detailed cost analysis using the protocol, manuals and investigational brochure, if applicable. We have a standard budget template that is detailed and transparent, but have also developed sponsor-specific rate cards to facilitate smooth budget negotiations and provide our site fees in advance.

Our Institutional Rates

Our goal is to be cost neutral, with a standard fee schedule updated each calendar year and applied consistently across programs to external sponsors. Our personnel rates are within fair market value and reflect protocol requirements. We are a non-profit organization with strict policies prohibiting underwriting research costs and preventing unnecessary surpluses.

All study activation workstreams (IRB, contract, budget) are conducted in parallel, however IRB approval notification will not be released until a final contract is signed. We typically utilize central commercial IRB but can use Hartford HealthCare local IRB as needed. A dedicated regulatory analyst is assigned to each study from beginning to end to facilitate opening and ongoing maintenance of required documentation and regulatory compliance.

IRB Policies, Fees, FWA and Membership

All studies are shepherded through the process by a highly sophisticated project manager to ensure timely activation, mitigate unnecessary delays and monitor progress and deliverables through the activation continuum. Our standard activation times are 12 to 18 weeks.


Rapid Activation

Rapid activation - an exclusive, fast-track mechanism for study activation – is reserved for high-priority studies at HHCCI. Rapid activation target timelines are 56 days from time of site selection to open to accrual, compared to standard 90-day timelines*.

Priority studies essentially skip the study activation queue and are assigned additional resources to meet aggressive timelines. Additionally, an oncology research leadership team member, with authority to make swift executive decisions, is assigned to ensure project success by monitoring progress and removing bottlenecks in real time.

Rapid activation requires approval by the Research Leadership Council, which critically evaluates opportunities to assess the:

  • Degree of alignment with our strategic initiatives
  • Relationship to balance scorecard focus areas
  • Internal capacity to ensure adequate resources to reliably deliver
  • Return on investment

*Timelines are calculated from study selection official memo or Disease Management Team approval notification. All days are calculated in workdays, including the first day and excluding the last day, weekends and public holidays.


Research Laboratory and Biospecimen Management

The clinical research laboratory is fully equipped with the following instrumentation: refrigerated centrifuge, ambient centrifuge, -20ºF freezer, -80ºF freezer, 32ºF refrigerator, laboratory hood, water bath, Vortex machine, calibrated pipettes, dry ice and supplies. All freezers/refrigerators are on daily temperature monitoring and records are meticulously kept and stored for documentation. These main instruments are also on red outlet plugs that trigger backup generator electricity if needed.

HHCCI clinical and research managers are on an on-call backup paging system and are immediately notified should any freezers/refrigerators malfunction after hours or on weekends. All our instrumentation is calibrated before use and maintained yearly by the Biomedical Engineering Services Department.

Adjacent to the Clinical Innovations Unit, the research laboratory and its expert staff perform complex processing for early phase clinical trials. Our dedicated bio-specimen team includes a unit leader, two research coordinators and a pathology assistant who are IATA-certified to support clinical and translational research across the HHCCI. The team is responsible for timed specimen collection, processing, storing, tracking, inventory management and shipping. Complex processing utilizes the research laboratory rather than the clinical laboratory. Research coordinators and biospecimen research laboratory staff complete all shipping and handling.


Investigational Pharmacy

Hartford HealthCare’s investigational study drug program provides high-quality services regarding investigational medications used in clinical research here. This includes meeting all regulatory requirements associated with storage, preparation, management and dispensing of investigational medications. Research pharmacists support and collaborate with HHC’s research community to facilitate successful outcomes for projects.

The research pharmacy on the Hartford campus provides 24/7 inpatient services, outpatient specialty pharmacy five days per week, and outpatient infusion staffing six days per week. There is a dedicated IDS manager who oversees research pharmacy across all campuses, and IDS can provide standard drug preparation capability with BSL2 capacity. The research pharmacy is fully equipped to perform oncology clinical trials including but not limited to refrigerators, -20 and -80 ultralow freezers, liquid nitrogen storage tanks, electronic temperature tracking, electronic inventory control system for investigational drugs (Vestigo), pre-built oncology research order sets (EPIC Beacon) and use of the Pyxis system for narcotic and drug stock control. IDS SOPs cover transport and handling of biohazardous products, transfer of investigational product from one location to another, and preparation of all sterile compounded products and standard agents.

The investigational pharmacy manager reviews all protocols, attends SIV meetings, provides secondary checks to ensure protocol compliance, signs off on research treatment plans and participates in mock walk-throughs as necessary.


Technology/Systems

Healthcare and research software programs are harmonized and utilized across the system.

  • Electronic records. We have a single instance of the electronic health record (EHR) with one standard of care across the system. Direct on-site access is granted to verify source and remote access is permitted to facilitate remote monitoring and auditing.
  • Clinical trial management. All studies and research participants are entered into our central database which interfaces with our HER.
  • Instant communication. Our internal care team uses a secure instant messaging platform to communicate.
  • Digital signatures. A 21CFRpart11-compliant electronic signature system ensures prompt review and timely documentation of clinical trial documents.
  • Virtual health. Technology eases the burden of research participation and we offer IRB-approved virtual health options for research patient visits.

Radiation Oncology

Our team helps advance important research initiatives in radiation oncology, putting us at the forefront of innovation in the field. Our state-of-the-art technology includes:

  • 4D CT simulation to assess target and normal tissue movement during the respiratory cycle
  • Intensity Modulated Radiation Therapy (IMRT) and Volumetric Modulated Arc Therapy (VMAT or RapidArc)
  • Image-Guided Radiation Therapy (IGRT) utilizing MV imaging, KV imaging cone beam CT scanning, and Exactrac with 6D robotic motion
  • 3-dimensional Conformal Radiation Therapy
  • Deep Inspiration Breath Hold technique for treating left breast cancers
  • Low-Dose Rate Brachytherapy for prostate cancer, head and neck cancer, soft tissue sarcoma and other tumor types
  • High-Dose Rate Brachytherapy for gynecologic, breast, prostate, head and neck cancer, lung and esophageal cancers, sarcoma and other tumor types
  • Systemic radioisotopes to manage bony metastatic disease and lymphoma
  • Stereotactic Radiosurgery (SRS) and Stereotactic Radiation Therapy (SRT) for primary and metastatic brain tumors
  • Stereotactic Body Radiation Therapy (SBRT) for lung cancer, spine lesions, liver lesions and other tumor types
  • Yttrium 90 radioembolization for primary and metastatic liver tumors
  • Collaboration with medical oncology colleagues to optimize personalized concomitant therapies including chemotherapy, immunotherapy and targeted molecules

Data Science

The Hartford Hospital Department of Research Administration is well-equipped with network-secured 32/64-bit computers using Windows 7 and/or Linux. Specialized database management includes SQL Management Studio, Navica and MySql WorkBench. Software for statistical analysis and data visualization includes SPSS, STATA, R, Python and TIBCO Spotfire. Databases are hosted on two network-secured virtual 2008 SQL servers, each of which contains multiple databases, and collections of securable objects. Every SQL server securable has associated permissions to be granted by the system administrator. Once approved, each user is granted a login and password to access the database. The servers are backed up daily and the architecture includes a building failure redundant cluster environment maintained offsite to ensure functionality.

We have a team of data managers experienced in data extraction from our EMR and creating sophisticated data collection tools, modeling and forecasting. They also have experience creating data feeds for IRB-approved studies.


Cancer Research & Clinical Trials

Clinical Trials