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Both the Massachusetts General
Hospital and Brigham and Women's Hospital have a long,
rich, and diverse tradition of excellence in clinical
research that continues to expand today. The extensive
resources for training clinical investigators and performing
high quality translational investigation include:
- An integrated full service primary,
secondary, and tertiary care hospital network with access
to large numbers of both local patients with common
diseases and national and international patients referred
for evaluation of rare disorders
- Over 600,000 square feet of
research space
- A diverse population of thousands
of basic and clinical scientists studying topics ranging
from very basic molecular biology to direct patient
management
The
Research Study Volunteer Program, RSVP for Health,
where individuals register to be notified about clinical
studies in their areas of interest (e.g. healthy volunteer,
or in therapeutic areas) is the latest in our expanding
services to further clinical research and to make our
community aware of important clinical studies.
The MGH and BWH Clinical Research Mission
Both the MGH and BWH have established
clinical research support programs to enhance translational
(bench to bedside) research, train clinical investigators,
increase clinical trial activity, and support the clinical
research programs of the Harvard-Dana Farber Cancer Institute
Joint Venture, and the Harvard Medical School. Through
academic enrichment programs and direct support services,
the MGH Clinical Research Program (CRP) and the BWH Center
for Clinical Investigation (CCI) are contributing to a
culture in which all forms of clinical research can flourish.
Both the MGH CRP and BWH CCI provide direct services and
resources to facilitate the performance of quality clinical
research.
Our clinical research services
provide:
- advice and support to beginning
investigators to help them design a study, locate a
mentor, obtain funding, and proceed through the regulatory
approval process;
- direct support services for
investigators (biostatistical consultation, links to
sponsors, study start-up and subject recruitment services,
access to a pool of experienced study coordinators who
can manage day-to-day protocol activities, and access
to project management services for large or multicenter
studies.); and
- advocacy for clinical investigators
within our hospital systems, serving on committees and
managing special projects.
The MGH and BWH clinical
research programs offer:
- biostatistical support
to all clinical investigators and consultation prior
to grant submission on study design, and statistical
analyses for inclusion in grant submissions and protocols,
statistical modeling, statistical analyses of preliminary
data, sample size calculations, and other biostatistical
issues.
- study start-up services
for investigators initiating clinical studies. Staff
offer assistance in preparing IRB submissions, preparing
budgets, identifying study coordinators, collaborating
with sponsors in securing support of investigator initiated
studies of scientific merit, and managing study initiation;
- subject recruitment
services to consult with investigators to design
effective recruitment strategies tailored to the protocol’s
target population, budget and timelines; and
- study coordinator services
offer the services of experienced study coordinators
for day-to-day management of clinical studies.
Our programs also serve as an interface
between clinical investigators and sponsors.
We are the first point of contact for an investigator
seeking a commercial sponsor or source of a novel therapy.
Our educational programs strive to improve
the quality and increase the quantity of clinical research
of clinical research by educating current and future investigators,
research nurses and study coordinators.
To learn more about the Brigham
and Women’s Hospital Center for Clinical Investigation,
click here.
To learn more about the Massachusetts
General Hospital Clinical Research Program, click here.
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