Significant progress has been made in the development, investigation, and clinical application of immunosuppressive agents to treat a variety of @entity792 . The expansion of clinical applications of these new agents requires the performance of large multicenter clinical trials. These large clinical trials are particularly important as one considers these agents for the treatment of type 1 @entity6 , which although autoimmune in its pathogenesis, is not classically treated as an @entity792 . Although these agents hold promise for amelioration or cure of this disease, they have the potential to facilitate infectious complications. There are limited data regarding the prospective assessment of infectious risks with these agents in trials of this nature. Pediatric subjects may be at greater risk due to the higher likelihood of @entity281 . A subgroup of experts associated with TrialNet (a National Institutes of Health [NIH]-funded Type 1 @entity6 research network) with expertise in @entity166 , immunology, and diagnostics developed an approach for screening and monitoring of immunosuppression-associated @entity281 for prospective use in clinical trials. The goals of these recommendations are to provide a structured approach to monitor for @entity281 , to identify specific laboratory testing and surveillance methods, and to consider therapies for treatment of these potential complications. Prospective evaluations of these infectious risks allow for greater scientific rigor in the evaluation of risk, which must be balanced with the potential benefits of these therapies. Our experience supports an important role for investigators with expertise in @entity281 in immunocompromised individuals in protocol development of immunosuppressive trials in type 1diabetes and potentially other @entity792 .

Screening and Monitoring for Infectious Complications When Immunosuppressive Agents Are Studied in the Treatment of XXXX .

@entity281 :: ('MESH:D007239', 'Disease') :: ['infections', 'primary infection'] @entity792 :: ('MESH:D001327', 'Disease') :: ['autoimmune disorders', 'autoimmune disorder', 'autoimmune diseases'] @entity6 :: ('MESH:D003920', 'Disease') :: ['diabetes', 'diabetes mellitus'] @entity166 :: ('MESH:D003141', 'Disease') :: ['infectious diseases']
@entity792 :: (MESH:D001327,Disease) :: ['Autoimmune Disorders']
