Clinical Research at Lahey Hospital & Medical Center

We have above average recruitment success due to the following factors:

• A large geographical patient population
• Research pages on both the Lahey Hospital & Medical Center intranet and www.Lahey.org
• Education of community and local groups about the latest treatments and developments pertaining to individuals’ specific medical conditions
• An active marketing department that develops recruitment advertising specifically focused for research purposes
• More than 3,000 patients treated each day in Lahey Hospital & Medical Center’s ambulatory care center
  Specialists in most clinical areas
• Complete clinical services offered to serve our extensive and diverse clinical population
• A very loyal physician and patient population
• An excellent compliance rate of participants in our studies
• Very low drop-out rate
• Based on these factors and our past success conducting clinical trials, we do not anticipate any problems recruiting patients for our clinical trials.

All research activity conducted at Lahey Hospital & Medical Center is monitored by the hospital’s local Institutional Review Board (IRB) to ensure the safety of study participants. The Lahey Hospital & Medical Center IRB is composed of Lahey colleagues and lay community members. The board typically meets monthly but also convenes weekly for time sensitive review.

All IRB correspondence at Lahey Hospital & Medical Center is facilitated through IRBNet. All protocols and procedures as well as consent forms are reviewed by the IRB prior to commencing the investigation and annually thereafter. All unanticipated events are reviewed by the IRB, and all changes to the protocols or the consent forms must be approved by the board.

Lahey Hospital & Medical Center’s Office of Research Administration is comprised of a diverse group of experienced administrative and clinical professionals. Investigators, study coordinators, clinical research associates and regulatory associates attend comprehensive training programs. Training involves review of proper management of clinical studies, Good Clinical Practice (GCP’s), participant safety, maintenance of study data, regulatory forms, completion of case report forms (CRF’s) and research quality assurance. All investigators and research staff participating in clinical trials must complete a research study session that includes Lahey-sponsored education and the CITI Research program with certification renewals every three years. Staff is encouraged to attend workshops and training as part of continual education.

Lahey Hospital & Medical Center’s various clinical departments provide an excellent clinical environment to conduct research investigations. Each department has sufficient exam rooms and large, friendly and comfortable waiting area where receptionists greet patients. All components of the study are conducted in the department, and, in the event other services are required (laboratory, radiology, etc.), they are usually available the same day at that location, reducing the need for repeat visits.

Lahey Hospital & Medical Center has a dedicated investigational pharmacy staffed by two registered pharmacists. The investigational pharmacy monitors and maintains all study drugs and medications.

The pharmacists participate in the investigational study process from the initial start-up phase through the duration of the clinical trial. All study drugs are shipped directly to the investigational pharmacy, and the pharmacists maintain all receipt and dispensing logs. The investigational pharmacists are an additional resource on research study drug questions, including side effects, concomitant medications and potential adverse events.

The Laboratory Department is concerned with supporting patient care activities through the provision of accurate and timely clinical laboratory information on blood, body fluids and other specimens, as well as providing consultation to the staff. Department sections include Phlebotomy, Immunology, Andrology, Hematology, Chemistry, Special Chemistry, Microbiology and Blood Bank.

Support services are provided by Information Systems, Specimen Processing and Client Services. The IATA (International Air Transport Association) has specific guidelines for handling and transportation of dangerous goods/hazardous substances. All personnel handling these substances require certification. Several members of the Laboratory involved with research study specimen packaging, labeling and shipping are IATA certified.

Lahey Hospital & Medical Center is one of two facilities in the area that has a GE Discovery Series 64-slice, hybrid positron emission technology (PET) and computerized tomography (CT) scanner as Nuclear Medicine. Our comprehensive PET/CT program is ACR accredited and is able to provide patients with the highest quality diagnostic PET/CT services currently available.

The Department of Diagnostic Radiology offers a full range of diagnostic imaging techniques and interventional services. The department maintains ongoing research partnerships with several high technology companies for the development of systems that apply computer technology to imaging processes. Consultations regarding individual cases are encouraged.

Neuroradiology is a subspecialty of Lahey’s Department of Diagnostic Radiology that is devoted to the imaging of the central nervous system (the brain and spine) and the head and neck. Imaging modalities used in neuroradiology include magnetic resonance imaging (MRI), CT scan, diagnostic angiography and myelography.