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Investing in Clinical Trials Compliance
The number of clinical trials is rapidly increasing both in the U.S. and throughout the world given the need for new treatments and cures for disease and disability. The backbone of the U.S.’s efforts to bring new drugs and technologies to market, clinical trials are essential to the research mission of academic health centers.
- Clinical trials can be sponsored by a variety of organizations, individuals, or federal agencies, including:
- Medical institutions
- Foundations
- Voluntary groups
- Pharmaceutical companies
- The National Institutes of Health (NIH)
- The Department of Defense (DOD)
- The Department of Veterans Affairs (VA)
- Clinical trials can take place in a variety of locations, including:
- Hospitals
- Doctors’ office
- Community clinics
- Academic health centers
- Academic health centers are ideal locations to conduct clinical trials due to the fact that the personal competencies and skills and research infrastructure necessary for such sensitive and highly regulated trials are largely found within academic health centers.
- Establishing an effective and efficient process for clinical trials billing can be particularly costly given the large number of individuals, the number of sites involved, and the IT integration that is necessary.
- The IT industry has not kept pace with clinical trial operations and the demand for services, often forcing academic health centers to turn to homegrown IT solutions or to purchase IT software from multiple vendors, thus increasing expenditures.
- The costs of compliance are skyrocketing; for a one-year period, some institutions reported increases as high as 70%, according to a 2005 AAHC report.
- The heightened concern over accountability, along with the regulatory environment, has changed the way academic health centers approach compliance, with the result that the organization, management, and funding of compliance has become a top priority for academic health center leaders.
- Compliance is considered to be the most commonly expanded academic health center function today, incorporating elements such as budgeting and billing, training, auditing, and monitoring.
A significant move toward consolidation of compliance functions is underway in academic health centers as existing decentralized organizational structures may not be able to accommodate new legal and regulatory environments. Research administrators are acquiring additional responsibilities and new administrative offices are being established for oversight.