Secrecy and Integrity in Clinical Trials

Wells, Robert J.

doi:10.1200/jco.2007.15.5234

Cited by 5 publications

(3 citation statements)

References 12 publications

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“…The key strength of this study design is its robust ability to reduce potential bias that may lead to inaccurate results. Proponents of RCTs tend to praise both the statistical and ethical virtues of this approach (Piantadosi, 2008), while critics have concerns that relate primarily to what they perceive to be ethical flaws (Wells, 2008). Although some may disagree, the fundamental ethical requirement for the conduct of RCTs is generally considered to be that current evidence supports a condition of equipoise: i.e., there is no clear evidence which exists with respect to the superiority of the two treatment options within an RCT (Freedman, 1987; Gifford, 2007; Miller & Brody, 2003).…”

Section: The Randomized Clinical Trialmentioning

confidence: 99%

Both Sides of the Coin: Randomization from the Perspectives of Physician-Investigators and Patient-Subjects

2010

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Randomization is the "gold standard" design for clinical research trials, and is accepted as the best way to reduce bias. Although some controversy remains over this matter, we believe equipoise is the fundamental ethical requirement for conducting a randomized clinical trial. Despite much attention to the ethics of randomization, the moral psychology of this study design has not been explored. This paper analyzes the ethical tensions that arise from conducting these studies, and examines the moral psychology of this design from the perspectives of physician-investigators and patient-subjects. We conclude with a discussion of the practical implications of this analysis.

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Section: The Randomized Clinical Trialmentioning

confidence: 99%

Both Sides of the Coin: Randomization from the Perspectives of Physician-Investigators and Patient-Subjects

2010

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“…Potential conflicts of interest are common in our field of clinical cancer research, 9 , 10 with complex financial relationships and conflicts of interest that may exist between the pharmaceutical industry and individual physicians, 9 , 11 ‐ 14 academic institutions 7 ‐ 9 , 11 ‐ 15 and consumers, 16 ‐ 18 and the potentially adverse effect that these relationships can have on individual patient care and public health. One author has gone as far as saying that, “We are compromising our integrity and the safety of research subjects, while engaging in unethical research practices and undermining ethical standards of research” 19 …”

Section: The Impact Of Duality Of Interestmentioning

confidence: 99%

“…One author has gone as far as saying that, "We are compromising our integrity and the safety of research subjects, while engaging in unethical research practices and undermining ethical standards of research". 19 Several studies in oncology have found a positive association between pharmaceutical industry sponsorship and the reporting of positive outcomes (even if not clinically significant), 20,21 manipulation of clinical trials, 22 hiding of "preliminary data sets" 19 and leaking of preliminary results to the investment industry by clinical researchers. 23 All such activities cast doubt on the trial results and the judgements involved in producing guidelines, when potential conflicts of interest are declared.…”

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confidence: 99%

Are self‐regulation and declaration of conflict of interest still the benchmark for relationships between physicians and industry?

Haines

Olver

2008

Medical Journal of Australia

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Potential conflicts of interest do not imply wrongdoing, but can create bias, distort decision making, and create a perception that practitioners are being “bought “or “bribed” by industry. Transparency alone may not be sufficient to erase the doubts created when authors of clinical practice guidelines or editorials declare potential conflicts of interest. Can the subconscious obligation for reciprocation that exists when gifts are offered and accepted be fully negated? Analyses of published clinical cancer research studies have found a positive association between pharmaceutical industry sponsorship and reporting of positive outcomes, manipulation of clinical trials, and hiding of “preliminary data sets”. More problematic is the issue of clinical researchers leaking preliminary results to the investment industry. Influential literature reviews and treatment guidelines have been associated with widespread declarations of conflict of interest. Some potential solutions are: regulating pharmaceutical companies to declare all gifts to clinicians, or ban such gifts; for clinicians to carefully declare potential conflicts of interest or to provide pro bono advice without accepting industry sponsorship; and for all gifts and payments from industry to academic physicians to be coordinated by an independent review committee. Journals should only allow reviews, editorials, guidelines and opinion pieces to be written by those without significant conflicts of interest.

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Rigor in Monitoring Clinical Trials Is Ethical

Piantadosi¹

2008

JCO

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Secrecy and Integrity in Clinical Trials

Cited by 5 publications

References 12 publications

Both Sides of the Coin: Randomization from the Perspectives of Physician-Investigators and Patient-Subjects

Both Sides of the Coin: Randomization from the Perspectives of Physician-Investigators and Patient-Subjects

Are self‐regulation and declaration of conflict of interest still the benchmark for relationships between physicians and industry?

Rigor in Monitoring Clinical Trials Is Ethical

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