Our Commitment to Research

Rheumatic diseases are a major burden to the health of the U.S. population, causing substantial disability and taxing the limited resources of our current healthcare system—and exponential growth in the numbers of patients with chronic musculoskeletal disease is projected in the near future. There is a growing need for new clinical and pharmacological interventions to treat people with these conditions, most of whom receive their care from ACR members. Rheumatologists and rheumatology health professionals are dedicated to healing, preventing disability, and one day curing the more than 100 types of arthritis, and we must continue to support research to increase our ability to provide care for our patients.

The ACR continues to promote basic, clinical, and health services research in rheumatic and musculoskeletal diseases, which will translate into improvements in the care and clinical outcomes of patients. The ACR supports research and education through our professional meetings series, the publication of our journals, advocacy for increased funding for rheumatology research, and collaboration with the ACR Research and Education Foundation (REF). The ACR Committee on Research is charged with determining the emerging research priorities of our organization and developing a research agenda that comprehensively addresses the important rheumatic disease research areas. This agenda focuses on new technologies, infrastructure, and funding opportunities. The development of the Rheumatology Clinical Registry is one example of a technology innovation. This clinical data management tool is aimed at improving care and drug safety for patients with rheumatoid arthritis (RA), osteoarthritis, osteoporosis, and gout. The ARHP also has a research committee with a strong emphasis on support for new and established researchers. In the coming year, these committees will be revising the ACR’s research agenda to meet the needs of our research community.

More Support for Scientific Programs

The ACR works closely with the National Institutes of Health (NIH) to support strong scientific programs that will improve the health of patients with rheumatic diseases. Each year, ACR, REF, and ARHP leadership convene face-to-face meetings with senior staff of different NIH institutes and centers to discuss ways to work together to take maximal advantage of funding opportunities for our academic researchers. This year’s meetings have focused on strengthening the relationship between the ACR and NIH, including discussions about the ACR’s research agenda, progress made with the REF’s Within Our Reach: Finding a Cure for Rheumatoid Arthritis campaign, and ways to facilitate an exchange of ideas on current and future funding opportunities.

In addition to these efforts, the ACR continues to advocate for increased funding of federal programs engaged in vital research to combat arthritis and related diseases. Three times a year, the ACR goes to Washington, D.C., to encourage Congress to strengthen NIH funding. Support for rheumatology research programs is essential to the development of innovative treatments that will improve the quality of life for our patients and lead to more cost-effective care. Adequate funding from NIH is necessary to ensure a healthy academic rheumatologic community so that we have enough competent educators to teach the next generation of rheumatologists and rheumatology health professionals.

The ACR also advocates for the formulation of public policy to improve the care of people with arthritis and other rheumatic diseases. The recently passed Patient Protection and Affordable Care Act included many important provisions to improve healthcare access for our patients. The ACR, along with other physician and patient organizations, secured increased reimbursement for bone density testing, which allows practices to continue providing these necessary services in-office and not in a hospital setting.

Through the REF, the ACR seeks to increase research in the rheumatic diseases while fostering the development of early career investigators. The REF meets a vital need in the community, providing funding from the early years of medical and graduate school, through fellowship training, and into the early years of a career in academic research. The REF is committed to supporting research and training that advances the prevention, treatment, and cure of rheumatic diseases.

Within Our Reach

In 2006, the REF launched the Within Our Reach campaign. The ACR and REF determined that a targeted research funding effort in RA was needed due to a dramatic decline in NIH and Arthritis Foundation (AF) funding. A study at that time demonstrated that significantly more money was going to other diseases that were much less prevalent than RA. The goal of Within Our Reach was to rekindle interest in RA research, and four years in to the campaign that is exactly what has happened.

Through the Within Our Reach campaign, the REF has built an infrastructure to support additional groundbreaking discoveries and test hypotheses directly related to patient care that did not exist previously. Through this extensive research program, which includes a rigorous grant application and peer-review process, the REF has funded investigators with novel, innovative research projects in RA. To date, $24 million has been committed to fund 54 outstanding investigators across the country. These investigators are established and well-respected researchers, and a number of them have changed direction in their research efforts to specifically focus on RA. Additionally, the success of these investigators has resulted in 65 publications in peer-reviewed journals in just the last three years, and several investigators have received additional funding from the NIH. In fact, since 2007, NIH funding for arthritis has increased $24 million (not counting stimulus funds from the American Recovery and Reinvestment Act of 2009).

The Within Our Reach campaign has been tremendously successful, and one of the benefits has been the development of a diverse donor base. The campaign has received tremendous support from the physicians, patients, and our industry partners, with nearly $28 million raised to date. Over $9.7 million has been raised from nonindustry sources, including the initial $5-million commitment from the ACR, which provided the early campaign momentum needed for success, and $3.3 million from lay donors who had not previously been a focus of the REF. Initial discussions about expanding this targeted research initiative are ongoing, and the REF will likely expand this program to continue funding critical RA research and possibly expand into other inflammatory arthritis research areas.

Novel Clinical Trials

Despite improvements in therapeutic options, RA remains a serious and life-threatening disease. About 30% to 50% of patients continue to have active disease and how best to manage these treatment-resistant patients remains a challenge. Basic research efforts have identified a plethora of molecules that could be targeted.

RA clinical trial design came of age in the mid 1990s when the Food and Drug Administration (FDA), with help from many of our members, published a guidance document on conducting RA randomized clinical trials. This has served our community well, resulting in the approval of several new biologic therapies during the last 15 years. Nevertheless, conducting trials in 2010 is different than it was in 1995, when few therapeutic interventions were available other than methotrexate. There is now significant interest in improving the clinical trial design for drug development to enhance patient recruitment and reduce patient exposure to placebo. There are a number of questions in RA that need to be addressed regarding effective intervention. The movement to evaluate the “comparative effectiveness” of therapeutics will stimulate a new generation of clinical trials. Investigator-initiated trials, including those traditionally sponsored by the NIH, often address key questions related to mechanisms of action, personalized medicine including pharmacogenomics, active comparator trials, or patient-centered outcomes with an emphasis on quality-of-life measures, and can be complemented with translational research into genetic, gene expression, and metabolic biomarkers.

It has been clear to most in the RA clinical research arena that it is time to reevaluate this process to enhance our ability to conduct trials and most efficiently address the numerous clinical questions that have arisen over the last decade. Last month, the ACR held a strategy meeting in Washington, D.C., with key stakeholders to discuss how we can move the RA clinical trials field forward. The goal of this meeting was to identify unmet needs and priorities for future investigator-initiated and industry-sponsored clinical trials in RA. Attendees included investigators from across the country, as well as representatives from the various NIH institutes, the FDA, AF, and REF. This meeting hopefully will serve as the catalyst to stimulate innovative trial design and influence the NIH agenda.

The ACR remains committed to promoting rheumatology research, advocating for increased funding, and building a better infrastructure to support research in arthritis and rheumatic and musculoskeletal diseases. The ACR and all of its members understand the need for a strong academic-based rheumatology research effort. Through support of basic and clinical research efforts, subsequent improvement in the quality of life for our patients will follow.

Dr. Cohen is president of the ACR. Contact him via e-mail at [email protected].