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What is the CPCRA?
The CPCRA was formed in 1989 as a clinical
trials program that conducts research in primary care settings through a national network
of community-based clinical units. The CPCRA {currently} includes
16 units in 15 U.S. cities with more than 130 collaborating sites (in Bronx, NY; Camden, NJ; Chicago, IL; Denver, CO; Detroit, MI; Houston, TX; Newark, NJ; New Haven, CT; New Orleans, LA; New York, NY; Philadelphia, PA; Portland, OR; Richmond, VA; San Francisco, CA; and Washington, DC) that provide
HIV primary care for approximately 60,000 patients. Additionally, Associate Sites collaborate with the CPCRA network to enroll participants in targeted studies. In the SMART Study, four Regional Coordinating Centers oversee 27 U.S. associate sites (Arizona, California, Florida, Georgia, Illinois, Kansas, Minnesota, New Jersey, New York, North Carolina, Oklahoma, Texas, Wisconsin) and 187 sites in 33 countries (Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Lithuania, Luxembourg, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Russia, South Africa, Spain, Switzerland, Thailand, Uruguay, United Kingdom).
Together, the collaborating sites have
enrolled more than 35,000 HIV-infected individuals in 47 clinical trials.
Participating sites include private physicians' practices, public
hospital clinics, freestanding community clinics, university and
veterans' hospital clinics, and drug-treatment facilities.
Primary Objectives
The primary objectives of the CPCRA
are to:
- Conduct scientifically sound research relevant to the day-to-day management of HIV disease
- Integrate research into the primary care of persons with HIV disease
- Develop research questions relevant to community settings and to individual communities
- Involve community-based primary care providers in scientifically sound HIV clinical research
- Include in clinical research people previously under-represented: women, people of color, and injecting drug users
- Generate data about therapies and
treatment strategies that can be used in a wide range of patients
- Provide research results concerning
new therapies and treatment strategies to clinicians, clinical
researchers, pharmaceutical companies, and patient advocates
The results of CPCRA studies have significantly
improved the care of people with HIV disease and AIDS. The success
of CPCRA trials demonstrates that community-based research can generate
high quality, scientific data in a timely and effective manner.
Why CPCRA Trials?
The CPCRA, a national, community-based
clinical trials network, encompasses, within a single innovative
program, the elements necessary to conduct high quality clinical
studies.
Patient Access
Access to large numbers of patients
- As many as 3,000 patients have
been randomized to a study in a single year.
- As many as 7,500 patients have been
followed at one time.
Patient demographics that reflect
the current HIV epidemic
- Entry criteria for trials encourage
broad participation.
- Results can be applied to a wide
range of patients.
High patient retention
- Established clinician-patient relationships
foster patient retention and compliance.
- The lost-to-followup rate has averaged
less than 3%.
Long-term followup of patients
- The median followup of recent trials
is more than 3 years.
- Innovative clinical trial design
and management
- Ability to answer important strategy
questions pertinent to HIV primary care
Network Features
In addition, the CPCRA network offers:
- Scientific leadership and expertise
- Coordinated data collection and
management
- Comprehensive statistical analysis
and interpretation
- Education and training for researchers
and study participants
- Comprehensive support services (Division
of AIDS, NIAID, NIH): regulatory support, drug-distribution, DSMB
- A record of successful collaboration
with:
- Adult AIDS Clinical Trials Group
- Canadian Trials Network
- Centers for Disease Control
and Prevention
- Pan American Health Organization
- U.S. Department of Defense
Innovative CPCRA Trial Design & Management
CPCRA researchers approach clinical
trial design and management with an innovative outlook. Methodologies
developed and implemented by the CPCRA include:
- Standardized definitions for clinical
endpoints and an endpoint reporting and review system that expedites
study development and analysis - this system has served as a model
for other NIH-sponsored trials, as well as for industry-sponsored
trials
- Simplified data-collection forms
that are standardized across protocols to reduce the potential
for error, enhance the quality of data collected, and allow cross-study
analyses
- Co-enrollment and sequential enrollment
of patients into multiple studies (25% of patients are enrolled
in more than one clinical trial)
- Simplified toll-free telephone procedures
for randomization
- Followup data-collection visits
at standardized intervals in conjunction with standard primary
care visits
- Cross-study database used for observational
analyses and study design
- Incorporation of community input
into the design and implementation of CPCRA trials
Quality Assurance
The high quality of CPCRA data is the
result of quality assurance measures that include:
- Close monitoring of followup that
has minimized lost-to-followup across all trials
- Missed-patient-visit reports and
appointment reminders to ensure compliance with follow-up visit
attendance
- Education and training for CPCRA
researchers to enhance adherence to procedures and policies and
for patients to foster compliance
- Site-monitoring by an external contractor
to provide timely assessment of data quality to CPCRA units
- Comprehensive standards established
and monitored by the CPCRA Unit Performance Committee to help ensure unit accountability
- Data-quality-assurance plans, utilizing
a continuous quality improvement approach, designed for each unit
and approved by the CPCRA network
- Timely editing of case-report forms
by the Statistical and Data Management Center
- Quarterly quality control reports
to research units from the Statistical and Data Management Center
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