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Ann Thorac Surg 2004;77:1874-1875
© 2004 The Society of Thoracic Surgeons
a Division of Thoracic Surgery, Massachusetts General Hospital, Boston, Massachusetts, USA
b Geisinger Heart Institute, Geisinger Wyoming Valley Heart Hospital, Wilkes-Barre, PA, USA
c Division of Cardiothoracic Surgery, University of Mississippi Medical Center, Jackson, Mississippi, USA
d Louisiana State University Health Sciences Center, Louisiana State University Cardiovascular Outcomes Research Group, New Orleans, Louisiana, USA
e Division of Cardiothoracic Surgery, University of Colorado Health Sciences Center, Denver, Colorado, USA
f Cardiothoracic Surgery, University of Iowa Hospital and Clinics, Iowa City, Iowa, USA
g University of Washington Medical Center, Seattle, Washington, USA
h University of Texas Southwestern Medical Center, Dallas, Texas, USA
i Department of Thoracic and Cardiovascular Surgery, University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA
* Address reprint requests to Workforce on Clinical Trials, The Society of Thoracic Surgeons Headquarters, 633 N Saint Clair St, Suite 2320, Chicago, IL 60611-3658, USA
e-mail: hgaissert{at}partners.org
There exists today a critical need to stimulate clinical and translational research, in thoracic and cardiovascular diseases and beyond our field [1]. The Society of Thoracic Surgeons (STS) is acutely aware of the challenges facing our patients over the next decade. These include a preserved access to specialty care and a more efficient use of health-care resources. Within these constraints, cardiothoracic surgeons are asked to improve outcomes and to respond with rapid translation of improved therapies, from basic science research and clinical investigations, to better the care of the individual patient. Collaborative multi-institutional research is a critical component of an effective response to this challenge.
Members of the STS demonstrate their commitment to research daily by participating in virtually every regional and national cardiothoracic trial. The success of the National Cardiac Surgery Database and a growing national and international membership offer the STS new options to support collaborative research and a network to conduct trials. The existing site management, at more than 480 institutions participating in the STS database, provides a structure for future clinical investigations. Using the national database to facilitate collaborative research among its members would introduce new activities to the Society; such efforts should therefore be planned and defined with care. Certain considerations are intuitive. The STS itself should not conduct clinical trials, but should serve to identify thoracic surgeons (individually or in groups) with interest and skill in the investigation of the clinical problem at hand. The STS can assist interested parties, such as surgeons and institutions, and public or private trial management groups. The STS should not seek to duplicate efforts or compete for trial design, but rather should support clinical investigations in ways that are compatible with the objectives of the STS, "... to improve the quality and practice of thoracic surgery as a specialty; and to promote the professional and educational development of those surgeons" [2]. The Workforce on Clinical Trials, a component of the Council on Quality Assurance and Patient Advocacy, was formed under the new STS governance to establish evidence-based support for thoracic surgery, to educate and assist members interested in clinical trials, and to expand clinical investigations in all aspects of our specialty.
We understand "mentoring" as any support enabling the conduct of research without assuming the role of investigator, financial sponsor, or trial manager. The STS, through its Workforce in Clinical Trials, can assist in educating surgeons in clinical trials design and conduct, facilitate surgeon (and patient) participation in such trials through its National Database efforts, expand the clinical questions to be investigated, further enhance education and accrual of patients, and link these efforts together on a national and international platform. The Workforce will identify these opportunities and propose an appropriate role for the Society.
Various opportunities already exist. The National Cardiac Surgery Database, launched as an instrument for quality improvement and quantification of physician work-effort, stores data on more than 1.7 million patients. Similar data collection efforts are being implemented for general thoracic surgery and congenital cardiac surgery. The Society hosts the largest collection of perioperative data in the entire field of cardiothoracic intervention. The use of these data should reflect our responsibility to the public and to the members' practice of medicine. What better purpose than placing the National Databases into the service of research focused on the best interest of our patients? The accumulated information on clinical interests, patient populations, and the particular expertise of individual surgeons or institutions preserved within the database will allow thoracic surgeon-investigators to solve questions which were previously inaccessible to study. Trial management entities may seek to identify participants in clinical trials with the assistance of the STS. Joint investigations may be facilitated between surgeons, health-care institutions, and public or private enterprises. Topics for clinical investigation may include evaluation of specific surgical procedures, the epidemiologic background of surgical intervention, the utilization of surgical services, and outcomes of interventions. Such investigations will expand the topics for investigation, increase the number of participating institutions, and contribute to improving health-care quality.
Diverse methodologies in cardiothoracic research require individualized support. Device-oriented investigators may seek to identify the three or four most active surgeons or hospitals to maximize enrollment and reproducibility of results. In contrast, oncologic cooperative trials enroll patients from many institutions to control the influence of individual practice on outcome. All these investigators share the time-sensitive nature of their research. The potential efficiencies of an STS-mentored study design must therefore be convincingly realized.
The promise and the challenge of these new ideas can be shown in two examples. Currently the STS is involved in a clinical trial by using the Adult Cardiac Database infrastructure to identify participating surgeons and institutions. The trial will recruit 3,000 coronary artery bypass patients from 92 US hospitals. The time from initial planning to first patient enrollment August 2002 measured less than 1 year. The accrual as of July 20, 2003, was 2,052 patients. This model will hopefully be repeated many times in the very near future.
In the second example, conducting successful, large-scale collaborative trials in thoracic oncology has proved a difficult enterprise. Participation in lung cancer studies by patients and physicians alike remains poor, despite the disappointing long-term results of curative therapy. The STS can become an agent of change, by acknowledging the inconsistent outcome of current treatment, and assisting our members and our patients by promoting well-founded clinical trials. We must publicly declare participation in multi-institutional, peer-reviewed (National Institutes of Health, National Cancer Institute, American Heart Association, and so forth) prospective trials as the standard of care—at and above that of currently accepted conventional therapy. The best possible current treatment is not necessarily good enough. A standard-of-care declaration in support of prospective trials will encourage important clinical investigations and help to increase the number of eligible and informed patients who enroll in cooperative thoracic trials, without mandating participation in trials. An NCI-designated cooperative group, the American College of Surgeons Oncology Group (ACOSOG) was created in 1998 under the auspices of the American College of Surgeons to answer questions critical to surgical oncology within a multidisciplinary framework. Membership and participation in ACOSOG is open to all members of the STS. Through participation in ACOSOG, other NCI cooperative groups, or other local, regional, or national clinical trials groups, thoracic surgeons can develop protocols to answer specific clinical questions. Correlative basic science studies can be integrated within the clinical trial for tissue, molecular, and proteomic analysis. Their web site (available at: www.acosog.org) reviews currently active trials and describes similar mission areas as the STS. Closer relationships between the STS and the ACOSOG will enhance our mutual goals of surgeon education in clinical trials, and enhanced participation of both surgeons and patients in these trials.
There are risks inherent in this new role. The STS should not become entangled in the details of clinical trials management or design, and should carefully consider its responsibilities for mentoring individual studies. "STS-mentored" must not mean "STS-endorsed." The name of the STS should not become attached to any given study outcome. If financial and organizational interests overlap, the Society should adhere to its wisely enacted policies of disclosure.
By educating ourselves and the next generation of thoracic and cardiovascular surgeons, we exert the greatest influence on the role and direction of research in our specialty, and improvements in care for our patients. We anticipate that thoracic residents who participate in successful clinical trials during their training will be more inclined to contribute to studies once they enter practice. The Workforce will create specific resident education modules as part of the Thoracic Surgery Directors Association on-line residency core curriculum. Excellent educational opportunities will become increasingly important to attract the best cardiothoracic surgeons of the future. The Workforce will also conduct an educational program for members of the STS. A clinical trials course, modeled upon the American College of Surgeons Clinical Trials Methods course, is being planned. This course will teach essentials of clinical trial design and clinical trial management, including access to such trials and the ethics of clinical research.
The Workforce on Clinical Trials looks forward to an expansion of this kind of STS mentorship to improve care and access to care, and to advance knowledge in the specialty through innovative, timely, and relevant clinical trials. The public expects that patients participating in trials are guided by physicians who are responsible and accountable. The Workforce on Clinical Trials welcomes all comments and suggestions on its efforts as we work together to achieve these goals.
Acknowledgments
The authors, all members of the Workforce on Clinical Trials, acknowledge the excellent technical assistance of Mary Eiken in the preparation of this manuscript.
Footnotes
Doctor Ferguson is Chair, Council on Quality Assurance and Patient Advocacy; Dr Putnam is Chair, Workforce on Clinical Trials.
References
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