SEARCH

SEARCH BY CITATION

The publication of original research is the cornerstone of scientific inquiry and the advancement of new ideas and knowledge. Indeed, one of the reasons for the amazing progress in biomedicine in the past century is the openness of science and the ever-increasing speed with which information can be disseminated to other investigators who can confirm, extend, and sometimes refute the earlier findings in a self-cleansing and self-correcting process. Scientific resea rch does not occur in a vacuum, however, as many advances have broad impact for society as well as for individuals. Critical decisions about patient care, health care spending, public policy, national research priorities, and individual career choices can all be strongly influenced by scientific publication. In view of the wide ramifications of scientific research, data must therefore be collected, interpreted, and reported as objectively and accurately as possible.

In the past, biomedical research was typically performed by independent investigators or small groups of investigators at academic centers with funding from sources that did not have a direct interest in the specific outcome of any study. With the explosive growth of “big science” and the pressure for the rapid development of new treatments, the conduct of research has changed and its complexity has increased. In various and sometimes unexpected ways, investigators, their institutions, and funding sources may all have a stake in the success of a study in a manner that transcends the acquisition of new knowledge (1–3). While the potential for conflicts of interest may exist at multiple levels, financial gain is an area of major concern (4), especially in cases where authors or sponsors of studies may benefit significantly from patents or from the approval of new therapies or technologies.

Clinical trials that are sponsored by industry have raised the most serious and vexing questions about the potential for conflict of interest. These trials are essential to drug development and approval. Although the goal of such studies is improved patient care, the gains associated with a particular outcome are potentially great, and can accrue to the investigators performing the study as well as to the sponsoring company. For investigators, in addition to the satisfaction of contributing to important research, more tangible benefits may be realized. These benefits may include financial remuneration, enhanced reputation, increased referrals, and academic promotion. For the company, the outcome of the study can determine profitability and survival.

For trials on new drugs, the economic and logistical realities make pharmaceutical firms almost the only funding source. To demonstrate clear results and improvement over existing agents (in either increased efficacy or reduced toxicity), clinical trials often include very large patient numbers and organizational structures of daunting size and complexity. Multiple investigators, teams, and centers must cooperate in a matrix structure that incorporates a broad array of talents and skills and operates quickly and efficiently. In this type of structure, the role of investigators, in either academia or practice, can be limited and concerned predominantly with patient recruitment and evaluation. Correspondingly, companies often play a major role in the assembly and analysis of data for presentation in journals and at meetings. Thus, authors from outside the company may play a very different role from that in a traditional scientific article, where they are decisive in study design, data analysis, and manuscript preparation.

In 2001, the International Committee of Medical Journal Editors (ICMJE) published a document outlining emerging concerns related to conflict of interest in biomedical manuscripts (1, 5). These concerns went beyond the well-known issues pertaining to pharmaceutical company funding of studies and financial conflicts of interest. The ICMJE extended its concerns to the respective role of authors and sponsors in study design and data acquisition and analysis, focusing on the extent to which all of the authors had access to data, contributed to data analysis, and made decisions on which results to report. Importantly, the editorial stated that the members of the ICMJE “oppose contractual agreements that deny investigators the right to examine the data independently or to submit a manuscript for publication without first obtaining the consent of the sponsor” (1). It was their opinion that “such arrangements not only erode the fabric of intellectual inquiry that has fostered so much high-quality clinical research, but also make medical journals party to potential misrepresentation, since the published manuscript may not reveal the extent to which the authors were powerless to control the conduct of a study that bears their names” (1). The ICMJE recommended that all biomedical journals implement policies and procedures to address these types of concerns.

The Committee on Journal Publications (CJP) of the American College of Rheumatology (ACR) has discussed the problem of disclosure of potential conflicts of interest on several occasions in an effort to develop policies that promote fair and unbiased publication in its journals, Arthritis & Rheumatism and Arthritis Care & Research. In addition to their concerns about clinical research, the CJP and journal editors recognized that conflicts of interest can exist throughout the publication process, including review, and that conflicts of interest may occur with basic science as well as clinical science, whatever the funding source. The CJP and journal editors therefore felt that any policy needs to be encompassing of all manuscripts, given the primacy of the issue of authorship.

As a result of these discussions, the CJP recommended a new policy that has been approved by the ACR Board of Directors. The two ACR journals already have existing policies whereby authors disclose potential financial conflicts of interest and sources of funding, and this information has been published with articles. Under the new policy, we will request additional information regarding the specific role of authors in the conduct of the study, data analysis, and preparation of the manuscript for submission. Feedback on this policy has been obtained from physicians conducting clinical and basic research, from the journal editorial offices, and from the ACR's legal counsel. In the new process, the corresponding author will complete the disclosure form at the revision stage of manuscript preparation. The journals will test the new form for a 6-month trial period effective April 1, 2003. During that period, only financial disclosures and grant support information will be published with the article, according to current practice. The trial period will allow the journals to determine if any parts of the form are confusing or otherwise problematic to authors and make revisions accordingly. The decision as to which aspects of the disclosures will ultimately be published with the article will be made at the end of the trial period upon further deliberations of the CJP. A sample of the disclosure form may be viewed online at http://www.rheumatology.org/ar/disc/html or http://www.rheumatology.org/acnr/disc/html.

The determination of authorship has always been an ambiguous and sometimes fractious process. The rules have not always been clear and, indeed, have varied by institution, affiliation, and country. Contributions meriting authorship can range from the development of ideas, to performance of experiments, to analysis of data, to input into manuscript preparation and composition. Criteria for authorship have been outlined in the ICMJE Uniform Requirements for Manuscripts Submitted to Biomedical Journals (5).

The conduct of scientific research is a large enterprise that demands participation by individuals of diverse and highly specialized skills. Given the size of certain studies, it is impossible for one individual to perform all tasks and, in clinical studies, there may be functions that are appropriately performed by a funding company. Since authors are expected to differ in their contributions to a study, the specification of their various roles does not preclude or prejudice review or publication. Rather, the policy of authorship is intended to empower authors in their responsibilities and to provide a mechanism to assure that the science presented is a product of their work and reflection of their views.

While many journals publish information on authorship in the context of articles, delineation of the role of authors has value whatever the venue for the recording or dissemination of this information. In this regard, there is concern that greater disclosure of information on authorship could be divisive and jeopardize the enormous cooperation that currently exists between clinical investigators in practice and academia, industry, and the government. The success of this type of cooperation is evidenced in the approval of many important drugs for rheumatology in the past decade. This cooperation is based on trust among participants and a willingness to function as part of a team in which roles can be highly diverse. Delineating authorship should not be a force to discourage teams. Rather, it should be a force to assure that all members of a team fulfill their respective roles, including authorship. The critique of a manuscript should focus on the data, which should be widely available and subjected to careful analysis and scrutiny.

Modern biomedicine is a large, complicated world in which potentials for conflicts of interest abound. While these conflicts cannot be eliminated, they can be identified to prevent the uncertainties that can result when they go unrecognized. The new policy on disclosure will hopefully provide greater clarity in this realm, with benefits that translate into more effective therapy and improved patient outcome.

REFERENCES

  1. Top of page
  2. REFERENCES
  • 1
    Davidoff F, DeAngelis CD, Drazen JM, Hoey J, Højgaard L, Horton R, et al. Sponsorship, authorship, and accountability [editorial]. JAMA 2001; 286: 12324.
  • 2
    Drazen JM, Curfman GD. Financial association of authors [editorial]. N Engl J Med 2002; 346: 19012.
  • 3
    Nathan DG, Weatherall DJ. Academic freedom in clinical research. N Engl J Med 2002; 347: 136870.
  • 4
    Association of American Medical Colleges Task Force on Financial Conflicts of Interest in Clinical Research. Protecting subjects, preserving trust, promoting progress: policy and guidelines for the oversight of individual financial interests in human subjects research. Accessed Jan. 15, 2003. URL: http://www.aamc.org/members/coitf/firstreport.
  • 5
    International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. Accessed Jan. 15, 2003. URL: http://www.icmje.org/.