Michael Lockshin, MD, director of the Barbara Volcker Center for Women and Rheumatic Disease at Hospital for Special Surgery in New York and CRTF co-chair, speaks to the flipside of awareness, which might be called unlearning. “A big part of the challenge is going to be getting all of the world speaking the same language, meaning that, for APS treatment there’s a British approach, an Italian approach, a German approach…” and while some of these geocentric paradigms are in agreement, others conflict, and none are sufficiently based on hard clinical data. “Erkan’s paper on aspirin and primary thrombosis prevention is one of the very few that was a really solid clinical trial. The field is full of case reports of ‘here’s my experience’ type data, yet only a handful of people who have systematically looked at the results. But if we don’t do it now, then when?”
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March 2011A Call to ACTION
The concerns of Drs. Erkan and Lockshin betray a sense of urgency, and this is borne out by the post-CRTF phase in APS advocacy: the newly formed APS Alliance for Clinical Trials and International Networking (ACTION). The primary mission of APS ACTION is to facilitate high-quality, multicenter, multidisciplinary clinical research, which will be partially based on, and thereafter contribute to, an international APS registry. “The whole point is to have uniform definitions, joint recruitment, and standard treatment protocols so we can move forward,” says Dr. Lockshin. Specific tasks in moving toward this goal will be determined by APS ACTION subcommittees. Foci for these include clinical trial design; database creation, biospecimen sample collection, and funding initiatives, among others. APS ACTION currently includes 27 physicians from 19 international centers, and the goal is to increase the number of centers when the infrastructure is finalized. Drs. Erkan and Lockshin are two of the eight international members of the APS ACTION Executive Committee, which is chaired by Dr. Erkan.
The clinical trial subcommittee operates under the FINER criteria (Feasible, Interesting, Novel, Ethical, Relevant). Adhering to the Relevant, Novel, and Interesting should be easy enough, but Feasible? Yes, insists Dr. Lockshin, if you cast a wide enough net. “Any particular clinic probably can muster a couple hundred patients, of whom up to 50% would be eligible to enter a trial. But for statistical power you need to have a few times that number, so if we combine our clinical efforts we will be able to do these investigations.”