Originally published as JCO Early Release 10.1200/JCO.2003.04.025 on April 29 2003
Journal of Clinical Oncology, Vol 21, Issue 12
(June), 2003: 2387-2393
© 2003 American Society for Clinical Oncology
American Society of Clinical Oncology: Background for Update of Conflict of Interest Policy
The American Society Of Clinical Oncology*
From the American Society of Clinical Oncology, Alexandria, VA.
Address reprint requests to Suanna S. Bruinooge, American Society of Clinical Oncology, Cancer Policy and Clinical Affairs, 1900 Duke Street, Suite 200, Alexandria, VA 22314; email: bruinoos{at}asco.org.
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INTRODUCTION
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CONTINUED PROGRESS against cancer depends on the integrity of the clinical research enterprise. If physicians, patients, and the general public are to maintain confidence in the outcomes of clinical cancer research, the highest standards should be required of those conducting the research. It is for this reason that the American Society of Clinical Oncology (ASCO) has undertaken a process of review and reform of its existing conflict-of-interest policy.
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Background: Arguments for Stronger Policy
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ASCO’s current policy on conflicts of interest, adopted in 1996, is a strong one, as discussed below. However, in the ensuing years, clinical research has become increasingly dominated by private rather than public investment, presenting many more opportunities for questions and concerns about the financial interests of the physician investigators conducting the trial. While biomedical research funding through the National Institutes of Health (NIH) has increased substantially during the last decade, the overwhelming majority of NIH-funded research is not clinical, or patient-oriented. During the same time frame, the pharmaceutical and biotechnology industries have invested many billions of dollars in clinical research.
The increase in industry funding may be particularly pronounced in cancer therapies, where the industry trade association now reports more than 400 new products in various stages of development. Thus, industry is necessarily more involved in the clinical cancer research effort than ever before. At the same time, there is heightened awareness among both physicians and patients of the important role played by clinical trials in the comprehensive treatment of many cancer patients. A situation is created in which the influence of industry seems almost unavoidable in the arena of quality cancer care. In such a setting, every effort should be made to ensure the integrity of the research without imposing undue burdens. Therefore, ASCO determined that review of its already stringent policy was timely and necessary, with an intention to make that policy even stronger in the interest of enhancing public confidence in clinical cancer research.
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A Multiplicity of Conflicts Policies
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In the interim between ASCO’s first adoption of a conflict of interest policy in 1996 and the present, a number of different public and private institutions have articulated their own conflicts policies. Unfortunately, these policies are uncoordinated and inconsistent with one another. Although each institution is expected to establish its own policies, the variety of approaches and stringency is confusing, both to regulated persons and to the public at large, and does little to build public confidence. For example, components of the United States Department of Health and Human Services (HHS), such as the Food and Drug Administration (FDA) and the Public Health Service (PHS), including NIH, have dramatically different requirements for disclosure of financial interests.
As found in research conducted informally by ASCO staff, the range of requirements among different institutions, private and public, is impressive. Among private entities, the threshold for disclosing financial interests can vary from "any amount" no matter how small to substantial amounts, such as $100,000 at one institution. Governmental regulations include FDA requirements to disclose payments from a sponsor in excess of $25,000 during a clinical trial and 1 year after, and holdings of more than $50,000 equity interest in the sponsor, as well as NIH requirements for disclosure of payments in excess of $10,000 per year or of equity holdings in the sponsor in excess of $10,000 per year. Aside from these inconsistent requirements, an investigator may be subject to additional variations in mandates from his or her own institution or from regulations imposed by the state in which the research is conducted. Finally, some trade associations and medical societies have developed their own, differing, conflict-of-interest policies.
In the face of this inconsistency and recognizing its special responsibility as the leading medical society for physicians involved in clinical cancer research, ASCO has undertaken development of an enhanced conflict-of-interest policy designed to meet the needs of oncology in a research environment increasingly oriented toward private sector initiatives.
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Emphasis on Disclosure as Governing Principle
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ASCO’s new policy is dependent on an aggressive disclosure policy to facilitate transparency and accountability in clinical cancer research. The ASCO policy requires disclosure of any financial interest, with the sole exception of de minimus payments totaling less than $100. This policy cuts through the wide variety of different financial thresholds requiring disclosure in policies enforced by many different government and private research entities, and establishes a principal that any financial interest except the most minimal should be disclosed publicly.
Such disclosure will be required in connection with any ASCO activity, including publications, scientific or educational presentations at ASCO-sponsored meetings, and participation in the work of ASCO boards and committees. Through full disclosure of financial interests, ASCO seeks to enhance the ability of ASCO members and others taking advantage of the Society’s scientific and educational programs to assess fully the quality of presentations, including the objectivity of those involved. The goal is a more open process designed to facilitate the exchange of information and opinion regarding clinical cancer research.
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Prohibitions for Defined Investigators
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ASCO recognizes that, in the current clinical research environment, it would be counterproductive to institute a conflict of interest policy that resulted in the routine exclusion of significant numbers of investigators from various research activities. An overly regulatory approach to the management of potential conflicts might discourage participation either in ASCO-sponsored activities or in vital industry-funded research. In general, qualified physician investigators should be permitted to do both. Under both the existing ASCO conflicts policy and the new policy, physician investigators may do so except in very limited circumstances.
Specifically, ASCO believes that certain practices involving financial inducements to particular clinical trial results should be barred. These include finders’ fees and bonuses for accrual, making payments contingent on particular results, or suppressing unfavorable results from publication. Such practices are considered inconsistent with the integrity of the clinical trials process and will be precluded under the new policy.
In addition, individuals holding leadership positions—principal investigators (PIs), members of the trial’s executive committee, and members of the data safety and monitoring board (DSMB) for the trial—will not be permitted to receive certain specified payments or benefits from the private-sector trial sponsor during the course of the trial and before publication of trial results. Such restrictions are in no way meant to question the ethics of these individuals in leadership roles, but rather are intended to ensure public confidence in their objectivity as they undertake important management and review functions in the clinical trial. Moreover, the policy anticipates that exceptions to these restrictions may be granted by ASCO’s Ethics Committee and Board of Directors in certain defined situations calling for a more flexible approach. For instance, when the inventor of a new technology is translating it into clinical research, establishing a data safety monitoring board that ensures integrity of the data and safety of research participants may be the appropriate safeguard. Similarly, the restrictions on principal investigators or members of a trial’s executive committee are not applicable to trials sponsored by the NIH.
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Differences Between Old and New Policies
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ASCO’s first conflict of interest policy in 1996 was an important step forward, implemented at a time when many medical groups had not yet addressed the issue. Like the new policy, the 1996 policy depended primarily on disclosure as a means of managing potential conflicts. It was specific and comprehensive in its disclosure thresholds, requiring disclosure of ownership interest of $1,000 or more in a publicly traded company, as well as honoraria in excess of $2,000 per year or $5,000 over a 5-year period. Disclosure was required of any ownership interest in a privately held company and of any paid expert testimony. The policy recognized, without identifying them specifically, that there might be some financial interests so problematic that disclosure alone might not suffice and disqualification might be required. In those rare undefined circumstances, it was contemplated that the ASCO Board of Directors could take corrective action, but such action was left in the complete discretion of the Board without any articulated standards. Board action was specifically authorized against members failing to make the required disclosures.
The 1996 policy has worked well. Disclosure of financial interests is built into board and committee activities, and is very specifically mandated in connection with ASCO publications and presentations. However, in an era of heightened scrutiny of relations between physician investigators and industry sponsors, the Society determined that the existing disclosure thresholds were too generous and that an argument could be made that virtually all financial interests should be disclosed. In addition, the absence of a specific process for identifying situations where disclosure alone was inadequate made enforcement unlikely, and in fact no such situation has been identified under the 1996 policy. To meet these perceived shortfalls, the new policy will require expansive disclosure, and will make clear the circumstances in which disclosure alone will be insufficient and where prohibitions may be imposed.
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Process for Development of New Policy
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Review and possible revision of ASCO conflict of interest policy was undertaken by a task force under the jurisdiction of ASCO’s Public Issues Committee. Members of the task force, assisted by ASCO staff, considered the current conflicts policies of a variety of entities involved in clinical cancer research, including cooperative groups, major cancer centers, and other academic health centers. Conflicts policies of several medical societies, other professional organizations, and federal government agencies were also reviewed.
With the fairly stringent requirements of the existing 1996 policy as a starting point, the task force drafted a new policy with much greater disclosure requirements and much more specificity as to the rare circumstances in which disqualification rather than mere disclosure will apply. Enforcement mechanisms and an exceptions process were also added. (Table 1 compares the old and new ASCO policies with those of the Association of American Medical Colleges, the FDA, and PHS.)
The draft of the new policy was reviewed on a number of occasions by the Public Issues Committee and in three different meetings of the Board of Directors. The Board of Directors also took the unprecedented step of placing the draft policy on the ASCO Web site to solicit comment from members. After numerous refinements to address concerns of those submitting comments (both the general membership and the Board of Directors), the draft policy was adopted unanimously by the Board.
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Scope of New Policy
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The new policy applies specifically only to ASCO members, employees, or staff, and those who seek to participate in ASCO activities, such as ASCO scientific or education programs, or submit articles for publication in the Journal of Clinical Oncology. Thus, those who fail to comply with the terms of the new policy could be foreclosed from participation in those activities or even from membership in ASCO. The policy specifically recognizes that ASCO has no enforcement authority over the conduct of clinical trials generally, over the process of informed consent for trial participants, or over management within other institutions, such as cancer centers, of trial-related activities. Nevertheless, the hope is that the new ASCO policy will become a model for adoption of similar policies in other clinical cancer research settings.
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Implementation Issues
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Some may regard the adoption of the new conflict-of-interest policy as a cause for concern with the potential to disrupt ongoing relationships. It is important to reiterate that the overwhelming majority of actions required under the new policy involve no more than full disclosure of financial interests. Significant disclosure is already required under the current ASCO conflicts policy, and additional disclosure should impose no meaningful new burdens. For those in leadership positions in clinical trials, attention must be given to ensuring that financial interests are divested before the effective date of the new policy.
Recognizing that such adjustments may be required, the new policy provides generous time for implementation. The new policy does not become effective until 12 months after this publication in the Journal of Clinical Oncology and will apply only prospectively after the effective date. In addition, restrictions on financial interests held by those in clinical trials leadership positions will apply prospectively only to trials beginning accrual subsequent to the effective date.
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CONCLUSION
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ASCO takes very seriously its leadership role in clinical cancer research. With the adoption of the new conflict-of-interest policy, ASCO has enhanced its already strong position on conflicts as they may arise in the context of ASCO activities. However, perhaps equally important, ASCO has in effect issued a challenge to all other entities in clinical research to match the rigor and intensity of ASCO’s own policy as those organizations issue guidance on issues of disclosure and disqualification. It is hoped that such policies will encourage participation in clinical trials and eventually progress against cancer by bolstering public confidence in the integrity of clinical cancer research.
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NOTES
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* ASCO sincerely appreciates the contributions of the following individuals who devoted much time and effort to this project: Paul Bunn, MD (University of Colorado Cancer Center, Denver, CO), Ezekiel Emanuel, MD, PhD (National Institutes of Health, Bethesda, MD), Lowell E. Schnipper, MD (Beth Israel Deaconess Medical Center, Boston, MA), and Sam Turner, Esq. (Ropes & Gray, Washington, DC). 
Submitted April 3, 2003;
accepted April 4, 2003.
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J. Clin. Oncol.,
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24(3):
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INTRODUCTION
Background: Arguments for...
