The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives

2003 ◽  
Vol 31 (3) ◽  
pp. 398-418 ◽  
Author(s):  
Trudo Lemmens ◽  
Paul B. Miller

Over the past 5 years, a series of articles in leading American newspapers has revealed the extent to which the conduct of clinical trials may be affected by inducements offered by corporate research sponsors and accepted by some unscrupulous physicians. The cases described were disturbing. They involved physicians engaged in excessive “enrollment activities” in exchange for money. Some of these physicians perpetrated fraud, falsifying their recruitment records in order to increase their profits. Others ignored exclusion criteria designed to ensure the safety of subjects and the validity of research results, referring their patients to research investigating treatments for conditions from which they did not suffer. One of the articles reports that physicians focusing exclusively on commercial research regularly divulge annual incomes upwards of $1,000,000 with profits in excess of $300,000. Two physicians accumulated well over $10,000,000 through clinical trials activities in less than a decade.

2021 ◽  
Author(s):  
Paulo Cesar Morales Mayer ◽  
Caroline Amélia Gonçalves ◽  
Franz Porzsolt

Abstract Background: Evidence-Based healthcare deals basically with published clinical trials to guide the decision making on what treatment to use for any specific conditions.Aims: The present paper assessed the inclusion and exclusion criteria used in clinical trials of cervical cancer aiming at establishing a clear distinction between each criterion.Methods: We performed a bibliographical search in pubmed with the terms cervical cancer and treatment or therapy filtered for clinical trials with human subjects for the last ten years. A total of 30 papers were used extracting and classifying the inclusion and exclusion category according to the characteristic they described. Results: We found no clear parameter to establish which criteria could exclusively serve as inclusion or exclusion across the papers, about 56% of the categories identified were found either listed as inclusion or exclusion criteria or even as both in some cases.Conclusions: The key issue of selection criteria is not in its form but in its function, the first point to consider is if the trial is experimental (focused on efficacy and proof of principle) or observational (pragmatic trials, focused on effectiveness and real world conditions). We suggest, inclusion criteria should be broad, focused on the investigated condition; exclusion criteria should apply only to the subset of this “included” population, and do not take part in observational studies. These conclusions do not serve only for researchers but should affect practitioners and policy makers to correctly compare the results of investigated treatment.


Author(s):  
Kevin Verde ◽  
Lauren Johnson ◽  
Alex Clancy ◽  
Ashley Goldberg ◽  
Aleia Monden ◽  
...  

In the year 2015, it is estimated that the number of new cases of invasive melanoma will be 42,670 in males and 31,200 in females.1 Melanoma is treatable with early diagnosis; however, more advanced disease has devastating outcomes. For the past decade, two chemotherapy agents, dacarbazine and temozolomide, have been the treatment of choice for advanced stage III or IV melanoma requiring systemic treatment. Interleukin-2 (IL-2) therapy has been used but with serious side effects. More recently, the focus has shifted to monoclonal antibodies and enzyme inhibitors as the main systemic treatment for advanced cutaneous melanoma. This literature review gathered several studies which looked at the use of monoclonal antibodies, and compared monoclonal antibodies to conventional chemotherapy to assess whether there is a significant difference in tumor response, sustained remissions and side effect profile. An extensive medical literature review was conducted with PubMed and Cochrane databases using the keywords: “monoclonal antibody,” “melanoma,” and “treatment.” This list of articles was further narrowed by specific inclusion and exclusion criteria as well as reviewed for validity and quality using the GRADE system. Seven clinical trials were included in this literature review. One observational study evaluated the overall safety and efficacy of monoclonal antibodies, while another compared monoclonal antibodies versus placebo under the same variables. Three of the research studies were randomized clinical trials evaluating the safety and efficacy of monoclonal antibodies in comparison to chemotherapy. Two retrospective studies assessed patients from expanded access programs who did not meet criteria to participate in a clinical trial. All seven studies had similar inclusion and exclusion criteria and the patients were prognostically similar before starting treatment. Six out of the seven studies demonstrated superiority of monoclonal antibodies advanced-stage melanoma treatment. One study failed to demonstrate a statistically significant survival advantage over traditional chemotherapy. The use of monoclonal antibodies has been demonstrated to be a more specific and effective treatment approach than other therapies tried in the past. While monoclonal antibodies have demonstrated efficacy in first line treatment for advanced stage melanoma, further research is necessary to determine which combination of medications is most beneficial for these patients.


Author(s):  
Murugan Panchatcharam ◽  
Sravanthi Lakshmi Mukku

Clinical research involves working with human subjects to answer questions relevant to their well-being in an ethical manner. The current scenario from the past one year has drastically changed the face of the clinical trials. The present COVID prevalence and simultaneously conducting the research with all the regulations and the precautions has been the difficult task for the contract research organisations (CRO).


2011 ◽  
Vol 20 (1) ◽  
pp. 30-45 ◽  
Author(s):  
MAXWELL J. MEHLMAN ◽  
JESSICA W. BERG ◽  
ERIC T. JUENGST ◽  
ERIC KODISH

The United States, along with other nations and international organizations, has developed an elaborate system of ethical norms and legal rules to govern biomedical research using human subjects. These policies govern research that might provide direct health benefits to participants and research in which there is no prospect for participant health benefits. There has been little discussion, however, about how well these rules would apply to research designed to improve participants’ capabilities or characteristics beyond the goal of good health. When mentioned at all in the literature, this so-called enhancement research, as opposed to research aimed at diagnosing, preventing, curing, or treating illnesses or medical conditions, is usually dismissed without explanation.


2011 ◽  
Vol 35 (10) ◽  
pp. 361-363 ◽  
Author(s):  
Philippe Wuyts ◽  
Matthew Broome ◽  
Philip McGuire

SummaryBlogs have become increasingly popular over the past 15 years, especially with young people. In this editorial we discuss how the blogosphere is reshaping information exchange in healthcare. More specifically, blogs may change the doctor–patient relationship and provide clinically relevant information to mental health practitioners. However, the use of blogs as a source of clinical material raises ethical and legal issues.


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