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Scientific Fraud and International Research

Groote Schuur Hospital and University of Cape Town, Cape Town
Sandton Oncology Clinic, Johannesburg
University of Free State, Bloemfontein
Medical Oncology Centre, Rosebank, Johannesburg
University of Witwatersrand, Johannesburg
University of Pretoria, Pretoria, South Africa

To the Editor:Clinical studies are conducted with human subjects and have the aim of increasing and developing generalizable knowledge. The interests of the human subjects participating in clinical studies, who are also patients, need to be protected by ensuring that studies comply with ethical codes such as the Helsinki Declaration of the World Medical Association. This code, as revised in Edinburgh in 2000, requires, inter alia, that research conforms to scientific principles (section 11), that subjects be informed of the methods of the research study (section 22), and that in reporting, the investigators are obliged to preserve the accuracy of the results (section 27). The ethical conduct of clinical trials also has important implications for patients outside of studies. Clinicians use the knowledge gathered from these studies to treat future patients and to plan further clinical trials.

Misconduct and misrepresentation of data have been reported in an influential study, following a scientific audit.¹ We, on behalf of the South African Society of Medical Oncology (SASMO), express the strongest condemnation of such practices and take a position of "zero tolerance" toward scientific fraud. SASMO looks forward to working with the report of the American Society of Clinical Oncology’s Task Force on Oversight of Clinical Studies and welcomes the suggestion that audits assume their proper role in clinical studies everywhere.²

There is a concern that some may wish to cut back on the internationalization of clinical research, even though there is no reason to believe that there are regions that are exempt from the occurrence of fraud. It would be timely, therefore, to briefly discuss the reasons for the maintenance and expansion of international research, provided high scientific and ethical standards are maintained.

The global conduct of clinical research increases the opportunity for the generation of novel hypotheses. Karl Popper, a pre-eminent philosopher of science, has pointed out that new knowledge is unpredictable—otherwise it would not be new.³ One cannot prescribe how to develop new insights and hypotheses, which merit evaluation. This process is, however, optimized through a broad-based openness and interaction among scientists. This environment also facilitates the critical review of accepted knowledge and exposure of inconsistencies. This will call for further evaluation or for new hypotheses to more fully explain the worldwide experience.

Internationalization of clinical research will increase the benefits that follow from clinical studies. The scientific knowledge that ensues reaches across national boundaries but will be applied differently in different countries and communities. Clinicians involved with the research may develop a deep understanding of results so that they may contribute to the interpretation of the findings and implement them with a full knowledge of local conditions.

There are also indirect benefits from clinical research. Important lessons have been carried over from the conduct of clinical trials into clinical practice. These include the adherence to written treatment protocols, so that administered treatments are consistent and do not follow transient inclinations. The use of a common terminology, for example, the assessment of tumor response to treatment or the grading of complications, facilitates the ability of physicians to assess clinical findings and maintain continuity in care between clinicians.

Furthermore, clinical research assists in the maintenance of standards of medicine, which is particularly relevant from an international perspective. The Declaration of Helsinki, as revised in 2000, requires that the control arm in prospective randomized studies should be the best current therapeutic method (section 29). This might not always be attainable outside of trials, as all medicine is subject to cost considerations. The insistence upon a high standard of care within research, irrespective of the patent’s financial background, is a strong challenge to the disparities in service medicine provided to different communities. In addition, funding organizations, such as governmental health authorities or medical insurance societies, should be held globally accountable to scientific findings.

There are ethical reasons for the internationalization of research in accordance with a move toward a principle of greater inclusiveness within clinical studies. Underrepresentation of minority groups in studies is, for example, regarded as a cause for concern in clinical studies, and this representation is now frequently audited. This principle is reflected also in the development of the ethical codes, which govern the conduct of clinical research, such as the Nuremberg Code of 1947, the Helsinki Declaration of 1964, and the Council of International Organization for Medical Science of 1993. The committees producing these codes have become more globally representative and have increasingly included considerations for the global conduct of ethical research.

"The condition for liberty is vigilance" (John Philpot Curran, 1790). The scientific basis of our ability to care for patients will progress best when our clinical studies are as open and broad-based as is compatible with the maintenance of scientific and ethical standards.

REFERENCES

1. Weiss RW, Gill GG, Hudis CA: An on-site audit of the South African trial of high-dose chemotherapy for metastatic breast cancer and associated publications. J Clin Oncol 19: 2771-2777, 2001[Abstract/Free Full Text]

2. Norton L: High-dose chemotherapy for breast cancer: "How do you know?" J Clin Oncol 19: 2769-2770, 2001 (editorial)[Free Full Text]

3. Magee B: Popper. Glasgow, United Kingdom, William Collins Sons and Company Ltd, 1973

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This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Abratt, R. P. Articles by Slabber, C. F. Search for Related Content PubMed PubMed Citation Articles by Abratt, R. P. Articles by Slabber, C. F. Social Bookmarking                            What's this?