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Research at Mass General
The Translational and Clinical Research Centers at Massachusetts General Hospital combine to form a new 18-bed in-patient clinical research facility that is designed to support investigator-led studies and proof-of-concept clinical trials done in collaboration with industry.
The goal of the Massachusetts General Hospital Translational and Clinical Research Centers (TCRC) is to provide an infrastructure for researchers who conduct patient-oriented research.
The TCRC was established through blending the two entities of translational and clinical scientific inquiry.
The 18-bed inpatient facility is conducting a large number (>140) of active protocols, about 80% of which are investigator-initiated protocols funded by the NIH.
Approximately 20% of the study volume comprises industry studies. With the expansion of the facility from five to 18 beds this year, the TCRC has experienced a substantial increase in study capacity, and is seeking to increase its partnering activities with the local biopharma community.
To facilitate this, major improvements have been made in contract negotiation procedures and in institutional review board (IRB) approval times to meet the more pressing timelines typical of industry studies.
Investigations carried out by the TCRC include studies of normal and abnormal human physiology and studies of the cause, prevention, progression, treatment and cure of diseases that afflict individuals from all backgrounds.
Resources are provided to translate basic scientific discoveries into novel diagnostic and therapeutic methods that improve health care. Both adult and pediatric study subjects can be accommodated.
Located on the main campus of Mass General, the TCRC includes 18 beds and four infusion chairs. The staff includes expert research nurses, nurse practitioners, research nutritionists, laboratory technicians, project managers and others.
Each of our 18 beds is standardized to meet the hospital requirements for inpatient care and also has central monitoring. There are two private rooms with air flow monitoring that would be suitable for a wide range of studies involving gene therapy vectors or other agents where containment of biological materials is critical.
The highly experienced staff of the TCRC provides research support from all disciplines, beginning with protocol review, resource determination, operationalization and ongoing monitoring.
Each room in the new Clinical and Translational Research Center at Massachusetts General Hospital features central monitoring and oxygen at the headwalls.
Studies are conducted in accordance with Good Clinical Practice (GCP), and industry-standard standard operating procedures are in place to ensure data can be provided to relevant regulatory authorities.
For smaller biotech companies with limited in-house clinical expertise, the TCRC can form a collaborative partnerships that bring in-house disease experts from Mass General (as well as non-Mass General faculty from around the world) to help build clinical trial protocols that ask and answer key questions in the evaluation of a novel therapeutic.
The extensive laboratory and imaging technical capabilities of the hospital (e.g., genomics, specialized immunological assays, PET scanning) are available for studies where those modalities can illuminate key research questions.
Devoted to the on-site and timely preparation of patient samples, the study team can aliquot and ship/store routine and specialized laboratory samples (blood, urine, stool and biopsy). The laboratory contains alarmed -80 and -30 degree C freezers; as well as refrigeration for short-term storage to maintain specimen integrity and refrigerated and room temperature centrifuges for sample preparation.
Dedicated nutrition services include the provision of standard meals/snacks; the design and provision of specialized research meals; expert completion of anthropometric measurements including stature & weight, circumference and skinfold assessments; specialized indirect calorimetry measurement of energy expenditure; DXA determination of bone mineral density; assessment of body composition by impedance and DXA, administration of research questionnaires and detailed analysis of nutrient intake from food records and recalls.
Specialized nursing services include pharmacokinetic and pharmacodynamic study sampling of biologic fluids, frequent sampling protocols with maintenance of intravenous lines, physiologic measurements, administration of research questionnaires, administration of research agents and assistance in the collection of a variety of other research data. The nursing staff also ensures subject safety, including routine and specialized surveillance during all TCRC visits.
On the TCRC, nurse practitioners complete admission and discharge, daily rounds, assess for adverse events and in some cases consent participants. The clinical nurse specialist is an expert in clinical practice, provides consultation and supports nursing and investigators.
Please contact us by email for more information about the TCRC.
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