Task force report on antiphospholipid syndrome clinical research

Abstract

The Antiphospholipid Syndrome (APS) Clinical Research Task Force (CRTF) was one of the six task forces developed by the 13th International Congress on Antiphospholipid Antibodies (aPL) organization committee with the purpose of: (a) evaluating the limitations of APS clinical research and developing guidelines for researchers to help improve the quality of APS research; and (b) prioritizing the ideas for a well-designed multicenter clinical trial and discussing the pragmatics of getting such a trial done. Following a systematic working algorithm, the task force identified five major issues that impede APS clinical research and the ability to develop evidence-based recommendations for the management of aPL positive patients: (1) aPL detection has been based on partially or nonstandardized tests, and clinical (and basic) APS research studies have included patients with heterogeneous aPL profiles with different clinical event risks; (2) clinical (and basic) APS research studies have included a heterogeneous group of patients with different aPL-related manifestations (some controversial); (3) thrombosis and/or pregnancy risk stratification and quantification are rarely incorporated in APS clinical research; (4) most APS clinical studies include patients with single positive aPL results and/or low-titer aPL ELISA results; furthermore, study designs are mostly retrospective and not population based, with limited number of prospective and/or controlled population studies; and (5) lack of the understanding the particular mechanisms of aPL-mediated clinical events limits the optimal clinical study design. The task force recommended that there is an urgent need for a true International collaborative approach to design and conduct well-designed prospective large-scale multicenter clinical trials of patients with persistent and clinically significant aPL profiles. Following the final recommendation of APS CRTF, an international collaborative working meeting took place in Miami (Nov 2–4, 2010) that resulted in the formation of a clinical trial research alliance entitled: AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking (“APS ACTION”).