title: Do patients who participate in a clinic experimental protocol have the same probability of success from that who were not selected or refused to participate? Outcome surveillance, safety, and bioethical considerations in kidney transplant clinical research.
abstract: BACKGROUND
  Safety in conducting a clinical trial is a prerequisite for patients who will be enrolled into that study. The aim of the present study was to evaluate retrospectively if patient and graft survival were similar among patients who participated in clinical trials versus those who did not.
  
  
  METHODS
  We evaluated pretransplant and posttransplant characteristics of 245 kidney transplant (KT) patients who were selected to participate in at least one Phase II/Phase III clinical trial. We compared them with 361 KT patients who were not enrolled or refused to participate in those clinical trials; all studies were conducted at a single transplant center. Inclusion/exclusion criteria were as noted for each individual protocol. Only studies with enrollment at time of graft implant were considered.
  
  
  RESULTS
  Selection of patients participating in clinical trials in general exclude high-risk patients. In our experience, only 36% of transplanted patients were selected for a multicenter, prospective, randomized, international study that included changes to the strategies in the administration of immunosuppressive drugs already on the market or development of a new immunosuppressant. After 5 years, graft and patient survival rates were similar between those who participated and those who did not participate in a clinical study. Although our data were collected retrospectively, an alternative design to achieve these conclusions would be a noninferiority study.
  
  
  CONCLUSIONS
  Our results demonstrated similar rates of graft and patient survival among enrolled patients versus nonenrolled patients. Outcome surveillance offers safety in participating in clinical trials that involve changes in standard immunosuppression therapy and are part of the research necessary to develop patient-centered medical interventions.
authors.affiliation: Renal Transplant Unit, Organ Transplant Ph.D. Program, Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: J A
authors.initials: JA
authors.lastname: Pedroso
authors.affiliation: Renal Transplant Unit, Organ Transplant Ph.D. Program, Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: M P
authors.initials: MP
authors.lastname: Salerno
authors.affiliation: Renal Transplant Unit, Organ Transplant Ph.D. Program, Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Spagnoletti
authors.affiliation: Renal Transplant Unit, Organ Transplant Ph.D. Program, Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Pietroni
authors.affiliation: Renal Transplant Unit, Organ Transplant Ph.D. Program, Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Toscano
authors.affiliation: Renal Transplant Unit, Organ Transplant Ph.D. Program, Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Calia
authors.affiliation: Renal Transplant Unit, Organ Transplant Ph.D. Program, Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Favi
authors.affiliation: Renal Transplant Unit, Organ Transplant Ph.D. Program, Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Bianchi
authors.affiliation: Renal Transplant Unit, Organ Transplant Ph.D. Program, Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: J
authors.initials: J
authors.lastname: Romagnoli
authors.affiliation: Renal Transplant Unit, Organ Transplant Ph.D. Program, Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: fcitterio@rm.unicatt.it.
authors.forename: F
authors.initials: F
authors.lastname: Citterio
mesh_terms: D000328:Adult; D002423:Cause of Death; D002986:Clinical Trials as Topic; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000209:etiology; D006801:Humans; D007558:Italy / Q000453:epidemiology; D016030:Kidney Transplantation / Q000009:adverse effects / Q000401:mortality; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D035842:Research Subjects