Skip to main content
Journal cover image

Antiphospholipid Syndrome Clinical Research Task Force report.

Publication ,  Journal Article
Erkan, D; Derksen, R; Levy, R; Machin, S; Ortel, T; Pierangeli, S; Roubey, R; Lockshin, M
Published in: Lupus
February 2011

The Antiphospholipid Syndrome (APS) Clinical Research Task Force (CRTF) was one of six Task Forces developed by the 13(th) 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 non-standardized 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 truly international collaborative approach to design and conduct well-designed prospective large-scale multi-center clinical trials of patients with persistent and clinically significant aPL profiles. An international collaborative meeting to formulate a good research question using 'FINER' (Feasible; Interesting; Novel; Ethical; and Relevant) criteria took place in November 2010.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Lupus

DOI

EISSN

1477-0962

Publication Date

February 2011

Volume

20

Issue

2

Start / End Page

219 / 224

Location

England

Related Subject Headings

  • Pregnancy
  • Humans
  • Female
  • Congresses as Topic
  • Clinical Trials as Topic
  • Biomedical Research
  • Arthritis & Rheumatology
  • Antiphospholipid Syndrome
  • Antibodies, Antiphospholipid
  • Advisory Committees
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Erkan, D., Derksen, R., Levy, R., Machin, S., Ortel, T., Pierangeli, S., … Lockshin, M. (2011). Antiphospholipid Syndrome Clinical Research Task Force report. Lupus, 20(2), 219–224. https://doi.org/10.1177/0961203310395053
Erkan, D., R. Derksen, R. Levy, S. Machin, T. Ortel, S. Pierangeli, R. Roubey, and M. Lockshin. “Antiphospholipid Syndrome Clinical Research Task Force report.Lupus 20, no. 2 (February 2011): 219–24. https://doi.org/10.1177/0961203310395053.
Erkan D, Derksen R, Levy R, Machin S, Ortel T, Pierangeli S, et al. Antiphospholipid Syndrome Clinical Research Task Force report. Lupus. 2011 Feb;20(2):219–24.
Erkan, D., et al. “Antiphospholipid Syndrome Clinical Research Task Force report.Lupus, vol. 20, no. 2, Feb. 2011, pp. 219–24. Pubmed, doi:10.1177/0961203310395053.
Erkan D, Derksen R, Levy R, Machin S, Ortel T, Pierangeli S, Roubey R, Lockshin M. Antiphospholipid Syndrome Clinical Research Task Force report. Lupus. 2011 Feb;20(2):219–224.
Journal cover image

Published In

Lupus

DOI

EISSN

1477-0962

Publication Date

February 2011

Volume

20

Issue

2

Start / End Page

219 / 224

Location

England

Related Subject Headings

  • Pregnancy
  • Humans
  • Female
  • Congresses as Topic
  • Clinical Trials as Topic
  • Biomedical Research
  • Arthritis & Rheumatology
  • Antiphospholipid Syndrome
  • Antibodies, Antiphospholipid
  • Advisory Committees