Clinical Research | Lahey Hospital & Medical Center (2024)

Clinical Research at Lahey Hospital & Medical Center

Clinical Research programs at Lahey Hospital & Medical Center encompass more than 300 clinical trial protocols. The clinical staff of Research Administration possesses extensive experience in conducting research and clinical trials. Lahey Hospital & Medical Center is deeply concerned with safeguarding the rights and welfare of all those who participate as subjects in research projects by requiring that the research projects be reviewed and approved by the IRB.

Recruitment

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.

Lahey Institutional Review Board (IRB)

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.

Staff Training/Education

Lahey Hospital & Medical Center’s Office of Research Administrationis 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.

Clinical Departments

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.

Tertiary Services

Lahey Hospital & Medical Center is unique amongst research facilities. We provide numerous in-house specialized tertiary services in addition to laboratory, radiological, and basic clinical resources. We know that accessibility for both patients and study sponsors is essential in providing the best possible environment for the entire research process.

Investigational Pharmacy

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.

Laboratory

The Laboratory Departmentis 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.

Affiliations

In addition to treating patients at our Medical Centers in Burlington, Lexington and Peabody campuses, Lahey Hospital & Medical Center physicians see patients at several Community Primary Care Sites, Satellite Specialty Care Sites, Boston Children’s Hospital, Cape Ann Medical Center in Gloucester, and New England Rehabilitation Hospital in Woburn, Massachusetts.

Lahey Hospital & Medical Center is a partner of the Tufts Clinical and Translational Science Institute (CTSI) and collaborates with the Koch Institute of MIT.