scholarly journals Pitfalls in the Design of Clinical Trials for Prevention or Treatment of Acute Graft-versus-Host Disease

2006 ◽  
Vol 12 (1) ◽  
pp. 31-36 ◽  
Author(s):  
Paul J. Martin ◽  
Richard A. Nash
Keyword(s):  
Clinical Trials ◽  
Graft Versus Host Disease ◽  
Host Disease ◽  
Graft Versus Host ◽  
Acute Graft

scholarly journals Effectiveness of immunosuppression minimisation, conversion or withdrawal strategies in paediatric solid organ and haematopoietic stem cell transplantation: a protocol of a systematic review and meta-analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e037721
Author(s):  
Carlos Martin Saborido ◽  
Alberto M Borobia ◽  
Javier Cobas ◽  
Lorenzo D'Antiga ◽  
Esteban Frauca ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Blood Pressure ◽  
Clinical Trials ◽  
Graft Versus Host Disease ◽  
Graft Rejection ◽  
Host Disease ◽  
Graft Versus Host ◽  
Acute Graft

IntroductionPaediatric transplantation is the only curative therapeutic procedure for several end-stage rare diseases affecting different organs and body systems, causing altogether great impact in European children’s health and quality of life. Transplanted children shift their primary disease to a chronic condition of immunosuppression to avoid rejection. Longer life expectancy in children poses a greater risk of prolonged and severe side effects related to long-term immunosuppressive (IS) disabilities and secondary cancer susceptibility. The goal remains to find the best combination of IS agents that optimises allograft survival by preventing acute rejection while limiting drug toxicities. This systematic review will aim to determine the optimal IS strategy within the so-called minimisation, conversion or withdrawal strategies.Methods and analysisWe will search the following databases with no language restrictions: Cochrane Central Register of Controlled Trials in the Cochrane Library, OvidSP Medline and Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily; OvidSP Embase Classic+Embase; Ebsco CINAHL Plus, complete database; WHO International Clinical Trials Registry Platform search portal. We will include controlled and uncontrolled clinical trials along with any prospective or retrospective study that includes a universal cohort (all participants from a centre/region/city over a certain period). Cases series and cross-sectional studies are excluded. Two review authors will independently assess the trial eligibility, risk of bias and extract appropriate data points. The outcomes included in this review are: patient survival, acute graft rejection, chronic graft rejection, diabetes, graft function, graft loss, chronic graft versus host disease, acute graft versus host disease, surgical complications, infusion complications, post-transplant lymphoproliferative disease, liver function, renal function, cognition, depression, health-related quality of life, hospitalisation, high blood pressure, low blood pressure, cancer—other, cancer—skin, cardiovascular disease, bacterial infection, Epstein-Barr infection, cytomegalovirus infection, other viral infections and growth.

scholarly journals Endpoints for Clinical Trials Testing Treatment of Acute Graft-versus-Host Disease: A Joint Statement

2009 ◽  
Vol 15 (7) ◽  
pp. 777-784 ◽  
Author(s):  
Paul J. Martin ◽  
Carlos R. Bachier ◽  
Hans-Georg Klingemann ◽  
Philip L. McCarthy ◽  
Paul Szabolcs ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Graft Versus Host Disease ◽  
Host Disease ◽  
Graft Versus Host ◽  
Joint Statement ◽  
Acute Graft
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