The Association for Patient‐Oriented Research

In the 1990s, the hardships and challenges facing clinical research reached a peak. These were described initially in James Wyngaarden's article The Clinical Investigator as an Endangered Species, published in the New England Journal of Medicine in 19791 and subsequently by Edward H. ("Pete") Ahrens' monograph The Crisis in Clinical Research in 1992.2 The explosion of basic science knowledge had shifted research emphasis away from humans and human diseases. As the focus of researchers moved away from the bedside to the bench and from the patient to large clinical cohorts and databases, financial support from the National Institutes of Health (NIH), foundations, and charitable organizations also moved away from patient-oriented research and toward laboratory-based investigations. Consequently, career advancement within academic medical centers became even more difficult for the clinical investigator who worked with his or her patients to formulate and resolve scientific questions. Greater involvement of individual subjects in patient-oriented research is one suggestion for improving this area of clinical research. Similarly, encouragement for young clinicians and clinically-oriented investigators waned to the point of active discouragement due to the significant decrease in full-time researchers whose primary role was patient-oriented research. Finally, the "Tri-Societies" (American Association of Physicians [AAP], American Society for Clinical Investigation [ASCI], and American Federation for Clinical Research [AFCR]) dissolved their relationship and ended an almost 75-year history of hosting the annual Clinical Research Meeting. This had regrettable concrete as well as symbolic consequences for clinical research, not the least of which was the severing of ties between many of the leading individuals in academic medicine and young investigators aspiring to be a part of it. The turmoil and frustration within the clinical research community led to a meeting of a group of established patient-oriented researchers to discuss how to deal with the situation. The group, comprised of Pete Ahrens (Rockefeller University, New York, New York), Emil J Freireich (M.D.Anderson Cancer Center, Houston, Texas), Jules Hirsch (Rockefeller University), David Robertson (Vanderbilt University, Nashville, Tennessee), Michael Thoerner (University of Virginia, Charlottesville, Virginia), Judith L. Vaitu-kaitis (NIH, National Center for Research Resources, Bethesda, Maryland), and Gordon H. Williams (Harvard Medical School, Boston, Massachusetts), laid out a series of needs for patient-oriented research and researchers. These ideas were embodied in a document prepared by David Robertson and included: Increased visibility and advocacy for patient oriented research, both within academic medical centers and within the federal government including the NIH; Reward for excellence in patient-oriented research at all levels of professional development, thereby supporting full-time career ladders; Emphasis on the involvement of individual subjects in patient-oriented research and not only large cohorts involved in epidemiologic, therapeutic, and outcome studies; Bringing all patient-oriented researchers under "one tent" regardless of their training and clinical interests, thereby including not only general clinical research center (GCRC) program directors, but also GCRC users, patient-oriented researchers at institutions without GCRCs, and non-physicians interested in clinical research emanating from patient contact; and Links and collaborations with like-minded investigators abroad. The group felt that a new association was needed to address these needs, especially since the AAP and ASCI focused on recognizing career achievement more than promoting career advancement, and the AFCR appeared to be losing its patient focus, exemplified by its name change to the American Federation for Medical Research (AFMR). Furthermore although the GCRC Program Directors' Association (GCRC PDA) contained many of the distinguished leaders in patient-oriented research, it was limited in scope by definition and could not include clinical investigators who were not GCRC directors, those at institutions without GCRCs, and individuals without medical degrees. From these discussions, the Association for Patient-Oriented Research, or APOR, was born in 1998, committed to help address the crisis then facing clinical research. Its mission statement reflects this charge: The mission of the Association is to demonstrate and reinforce the centrality of scientific study of human subjects, in furtherance of the understanding of the causes of disease and to contribute thereby to disease therapy and prevention. The Association will work to maintain and expand clinically derived scientific knowledge, with auxiliary use of laboratory science, and to promote patient-oriented science as a core discipline of the profession of medicine. APOR representatives also decided that a year should not pass without a clinical research meeting. Therefore, its first conference was held in 1998 at Atlantic City, New Jersey, the site where many of the 20th century's major presentations of clinical research were made. The following year, APOR rejoined the GCRC PDA at its Arlington, Virginia meeting; at the following year's meeting, the AFMR also participated. Thus, the continuity of the clinical meeting was preserved, albeit without the participation of the AAP and ASCI. As the focus of researchers moved away from the bedside to the bench and from the patient to large clinical cohorts and databases, fi nancial support from the National Institutes of Health (NIH), foundations, and charitable organizations also moved away from patient-oriented research and toward laboratory-based investigations. The early organizers and members of APOR next set out to help enhance clinical research education and training. Along with other societies committed to clinical research, models were developed and commitments sought to revitalize training. Congressional mandates grew out of these efforts during the final years of Harold Varmus' directorship of the NIH and were implemented as the Clinical Research Enhancement Act of 2000. These included support for the K12, K30, K23, and K24 programs, which helped revitalize clinical research and training and were ultimately the basis for the Clinical and Translational Science Award (CTSA) program launched in 2005. APOR's position paper for clinical research (see http://www.apor.org), authored by Barry Coller, MD, David Rockefeller Professor of Medicine at Rockefeller University, and other APOR members, foreshadowed many of the most successful aspects of the CTSA program. In November 2006, based on the initiative and efforts of Dr. Hirsch, APOR hosted a national meeting, Visions of Clinical Research: The CTSA and Post-CTSA Periods, to discuss how the clinical research landscape might look in 20 years and what types of initiatives should be instituted to contribute to and support that environment. The meeting included formal presentations by NIH director Elias Zerhouni and more than 15 patient-oriented researchers; the content of these presentations can be found on the APOR Web site. A shorter follow-up meeting of this type was held approximately 6 months later, hosted by APOR's then-president Rose Marie Robertson, of the American Heart Association in Dallas, Texas. In subsequent years, APOR continued to actively promote clinical research in several venues. APOR is a major patient-centric clinical research organization that is international in character, and its members have been pivotal in advising and supporting the development of clinical research at sites in Europe, Asia, and South America. APOR's efforts are described primarily through its newsletter, which can also be viewed on the APOR Web site. Over its 11 years of existence, APOR has sought to periodically re-examine its history, its mission, and the strategies needed to achieve its goals. The Board of Directors has discussed in depth the status of patient-oriented research and how the association can contribute to its continued resurgence and impact on medicine. At its most recent retreat in November 2008, the board reaffirmed APOR's mission statement and adjusted slightly its objective and strategy because the inception of CTSAs represents another sea change in the clinical research environment. The APOR Board of Directors recently approved the following objective and strategy as indicators of our direction for the next few years: Our objective is to establish ready communication and common enterprise among physicians and other scientists who recognize the importance and challenge of patient-oriented research and who wish to make it a major element of their professional activities. This objective will be achieved by: Holding an annual forum that features the presentation of outstanding new contributions to patient-oriented research and includes networking opportunities for those who are engaged in this category of clinical research. Fostering activities that promote and recognize successful careers in patient-oriented research, thus ensuring that these clinical scientists are appropriately recognized for their activities in their own institutions and by academic medicine at large. Enhancing the development of effective training programs for careers in patient-oriented science. Advocating adequate funding for patient-oriented research by providing appropriate information to the public and to federal, state, and local governments as well as foundations and industry. From its inception, APOR has emphasized the preservation of certain traditional views while adapting to ever changing features of the medical and economic world around us. The glory days of the past, as exemplified by the annual spring meeting in Atlantic City, cannot be resurrected in the same form. The challenge is to build on these past strengths and spearhead a new agenda for the future of patient-oriented research. The founders of APOR recognized that the infrastructure for clinical research is more easily supported than the individuals who perform the research. This imbalance has challenged the GCRCs for years and is now being addressed by the CTSAs. APOR has been involved in a number of advocacy successes over the years, beginning with the Clinical Research Enhancement Act and continuing through the past year during which APOR and other members of the National Alliance of Societies for Clinical Research Resources moved the clinical research agenda forward at the governmental level. This cooperative group championed the needs for appropriate budgetary allocations to meet the promise and demands of CTSAs and increased funding for health and education programs through the House and Senate Labor-Health and Human Services-Education Appropriations Subcommittees. We are indebted to Dr. Williams and his advocacy committee members for leading this effort for APOR. At the same time, APOR must balance its efforts as an advocacy group for clinical research with its role as a facilitator for the clinical researcher. This will require recognition of several features of the current clinical research landscape. First, the clinical research community is a mosaic of individuals with diverse approaches, each focused on a common goal. APOR was prescient in including clinical investigators of all stripes in its initial mission and pointedly encouraging the inclusion of the many non-MD investigators involved in the study of human subjects. A key challenge remains how to achieve this integration in a meaningful way. One approach maybe to sculpt the patient-oriented method more clearly toward individual clinical subspecialties, in effect identifying distinct patient-oriented research challenges within different medical fields. APOR membership is multidisciplinary, and many members have focused medical interests. New strategic initiatives based on individual disciplines are now being crafted, and will appear in future issues of Clinical and Translational Science (CTS). In addition, the advent of CTSAs will likely increase the number of individuals carrying out clinical research at institutions without an NIH-sponsored program. Therefore, there will be a major need for a multidisciplinary organization that can serve as a "home" for these investigators. APOR provided this opportunity for researchers focused on humans and human diseases during the GCRC era and must strive to continue this role in the CTSA era. Moreover, APOR must continue to support the resurgence of an annual clinical research meeting. With the help of Marie Gelato, at SUNY, Stony Brook, (New York), APOR partnered again with the ACRT and the CTSA K-12 awardees in the organization of the 2009 National Clinical & Translational Research Education Annual Meeting, which was held in Washington, D.C in April 2009. In addition, APORs annual Ahrens Award, which is bestowed on a senior investigator who has made major strides and contributions in patient-oriented research, was presented at the meeting in Washington, D.C. to Dr. Williams for his pioneering work in endocrinology and hypertension. Additionally, APOR must enhance its communication with its members as well as the clinical research community at large. In this regard, we are delighted by the affiliation with CTS, which came about through the efforts and cooperation of CTS's editor-in-chief Arthur Feldman, MD, PhD, Department of Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania, and publisher Wiley-Blackwell with our new CTS APOR Editor, Charles Flexner, of Johns Hopkins University, Baltimore, Maryland. APORs affiliation with CTS will bring electronic access to the journal for 2009 and 2010, free of charge to all members. In addition, APOR will periodically provide views and comments about areas of importance to patient-centric research through this CTS column, thereby augmenting the APOR newsletter sent to all members regularly throughout the year. Finally, the current economic turmoil will very likely lead to alterations in the nature and delivery of health care, in which the patient-physician relationship is a cornerstone. The fiscal urgencies and demand for health care could act to loosen the patient-physician bond and thrust the physician into the role of a medical technologist. The value of maintaining clinical science as a special discipline that engages the curiosity and professional scholarship of the clinical investigator is of inestimable value. This discipline has always been and is likely to remain a major source of discovery in medicine and biology. APOR holds the distinction of being uniquely dedicated to the continued development of science at the bedside. This orientation has been eroded, and its restoration to a place of prominence in medical research is crucial to APORs mission. The association is committed to providing the necessary support and advocacy to make this possibility a reality. Patient-oriented research is greatly empowered by the environment of contemporary clinical and translational science as embodied in the CTSAs. The tools now available through the Human Genome Project, massive gene expression interrogations of individual genomes linked increasingly to anonymized patient records, etc., greatly magnify what can be done by medical scientists. However, ultimately, given human diversity, the output of this enterprise will express itself in the real world one patient at a time. I thank J Freireich, Jules Hirsch, David Robertson, and Gordon Williams. Their discussions of the ideology behind the creation of APOR, theirhelp in obtaining documents describing the discussions leading up its creation, and their critical review and participation in this manuscript have been invaluable.