Background Clinical research offers an important contribution to improvements in medical care. Despite intrinsic risks, especially in the early phases of drug development, a safety plan, careful selection of patients and close follow up can bring significant benefits in clinical outcomes.
Purpose To evaluate the benefits of clinical research in a single kidney transplant centre.
Materials and methods A retrospective analysis of a cohort of kidney transplant recipients enrolled in clinical trials between July 1998 and October 2013 in a single Brazilian centre.
Results A total of 2883 kidney transplant recipients were enrolled in 60 clinical trials conducted in a single centre. Most of these studies had as objective the evaluation of immunosuppressive regimens. Seven phase II studies enrolled a total of 175 patients (6%), 22 phase III studies enrolled 636 patients (22%), in 28 phase IV studies 1772 patients (61%) registered and 300 patients (10%) were enrolled into pharmacogenetics studies. The 10-year patient and graft survival of this population were 92.3% and 73.4%, respectively compared to 90.1 and 71.3% of the control group composed of regular patients (not enrolled in a clinical trial) followed in our Institution, p < 0.001.
Conclusions Several factors have contributed to better outcomes of research patients compared to regular patients. The study population is selected according to inclusion and exclusion criteria; complementary examinations and procedures not performed routinely are done on study patients for safety purposes. In addition, in our case, these patients also receive pharmacist assistance, performed by the study coordinators during the hospitalisation, at the research pharmacy and during the medical visits at outpatient clinic follow up. Complementary analysis must investigate the contribution of each variable above and how to bring these encouraging results into routine practice.
No conflict of interest.
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