Efforts to address and overcome barriers inherent in lupus clinical trials are a discussion that needs to be continually engaged in with the FDA, third-party payers, scientists, physicians who study new treatments, and lupus patients. We need to do more to educate regulators and insurance agencies about lupus, and continue the work of bringing down the barriers to treatment development. This should include convening key opinion leaders, the biotechnology sector, and the NIH and regulatory agencies to work on clinical trial design – something that must evolve further to optimize progress.
Dr. Merrill is the head of the clinical pharmacology research program and is a professor in the department of medicine, rheumatology, and immunology at the Oklahoma Medical Research Foundation, Oklahoma City. She has financial relationships with numerous pharmaceutical companies, including Human Genome Sciences/GlaxoSmithKline, maker of Benlysta. Ms. Raymond is president and chief executive officer of the Lupus Foundation of America, Washington, D.C. (www.lupus.org/newsite/index.html). She reports that she has no financial disclosures.