martes, 28 de junio de 2011

The Future of the NIAID Clinical Trial Units |

The Future of the NIAID Clinical Trial Units | "Previous Post
Leave a comment Research June 28, 2011
The Future of the NIAID Clinical Trial Units

By Payton Manizhe, Director, Office of Clinical Oversight, Division of AIDS, National Institute of Allergy and Infectious Diseases

As the National Institute of Allergy and Infectious Diseases (NIAID) moves forward to restructure its HIV/AIDS Clinical Trials Networks and include a new network focused on infectious diseases other than AIDS, the Clinical Trial Units (CTUs) will continue to play a critical role in establishing, developing, and implementing the networks’ scientific research agendas. Additionally, we are seeking to strengthen the CTUs to enhance our ability to conduct clinical trials around the world.

CTUs provide the scientific and administrative expertise and infrastructure to implement the scientific agendas of the clinical research networks. Each CTU includes an administrative component with performance and resource management responsibilities and Clinical Research Sites (CRSs), the hospitals, outpatient clinics, health maintenance organizations, community health centers, private physician practices, and clinics where clinical trials are conducted. They provide uniquely identified and characterized potential cohorts (e.g., demographics, incidence and prevalence of HIV/AIDS) as well as qualified professionals with the facilities and resources necessary to conduct clinical research in accordance with Good Clinical Practices. Each CRS will be affiliated with one CTU and support the scientific agenda of one or more networks.

Although these enhanced CTUs will be similar to the existing structures, we anticipate supporting fewer CTUs that will generally be larger in size and scope compared to what we have today. Each CTU will need to affiliate with at least two HIV/AIDS Clinical Trials Networks and have the capacity and flexibility to work with other research networks. CTUs will also have the option of working with the new non-AIDS Infectious Diseases Clinical Trials Network, which will be focused on antimicrobial resistance and emerging infectious diseases.

CTU applicants interested in participating in the non-AIDS network will need to describe, in their applications, their capabilities, including potential investigators, participation in similar research efforts, and infrastructure. Because the exact research agenda for this network is not completely defined, CTU applicants will not need to identify specific performance sites and CRSs in their application. This statement of capability will be judged as either acceptable or unacceptable, rather than given a numerical score as in previous years.

The overall strength of the CTU will be judged in part by the strength of its CRSs, as well as its plan to efficiently coordinate and manage the sites’ activities. Further, we expect CTUs to take on greater responsibility for overall CRS evaluation and performance, in collaboration with the leadership groups for each of the networks for which each site is affiliated. To support greater flexibility to address evolving scientific agendas, CTU principal investigators and site leadership will play a major role in identifying and evaluating sites, including the performance and productivity of CRS pharmacy and laboratory components. For example, an investigator at the CTU level may propose an additional network affiliation to an existing CRS or add new protocol-specific sites to the CTU to meet specific network and/or NIAID research goals. To avoid redundancy and optimize efficiency, the CTUs, in collaboration with network leadership, will have more responsibility for evaluating the ability of specific sites to conduct study protocols, provide operational support to the sites, and drive quality management processes.

Successful collaboration between the network leadership groups and the CTUs will also require transparency in financial and operational matters. For example, the CTUs will have increased responsibility for efficient resource utilization, including reallocation of resources as necessary. The CTUs will also have a substantial coordinating role in administration and resource management (financial, human, technical and clinical) for their individual units and the sites.

Partnerships will also continue to be an essential component of the NIAID clinical trials enterprise. To that end, NIAID remains committed to preserving and strengthening relationships with the communities where we conduct research through community advisory boards. To encourage new scientific research collaborations, NIAID will build a mechanism for allowing other partners (e.g., other NIH Institutes and U.S. Government agencies) to access the CTU infrastructure.

Enabling others to tap into our expansive clinical trial network will build efficiencies into the clinical trials process by helping to meet enrollment targets faster. Similarly, granting access to network resources, such as data management, regulatory and statistical expertise, and clinical monitoring capabilities will also help achieve mutual clinical research goals.

Overall, we believe that these changes will enable the CTUs to provide greater breadth in scientific expertise and capability, increased capacity, and greater flexibility in addressing scientific agendas of the newly awarded clinical trials networks. We welcome your thoughts and feedback.

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