This document discusses conflict of interest issues related to a clinical drug trial called Coughgone. It provides definitions and examples of conflict of interest, noting that conflicts can arise when secondary interests like financial gain influence professional judgments meant to primarily serve patients or scientific knowledge. The document analyzes potential conflicts in the Coughgone trial, including issues with the scientific credibility of the researchers, oversight and monitoring by the review board, and financial compensation structures. It concludes by discussing ways to minimize conflicts, such as disclosure and external review processes, as well as broader issues like potential bias and reliability of publications regarding drug effectiveness.
Call Girls Aurangabad Just Call 9907093804 Top Class Call Girl Service Available
Dr. Obumneke Amadi-Onuoha Scripts- 4_ crit analysis_case study
1. Dr. Obumneke Amadi-Onuoha_scripts_ 4
Critical Analysis
Critical research Trial case study
Conflict of Interests and Drug Development Issues of Coughone
What are examples of conflict of interest?
A conflict of interest(COI), are described as a set of conditions in which professional judgment
concerning a primary interest have a tendency to be disproportionately influenced by a secondary
interest, e.g. In the clinical context the physicians is primarily obligated to their patients, while in
the research context the primary interest is the scientific knowledge. On the other hand, a
secondary interest may consist of personal status, financial nature, academic credit and
promotion (Field & Lo, 2009, p.46). According to Lemmens & Singer (1998) having a COI is
an objective situation that is not dependent on fundamental motives. ( p.961). However, the
point of regulating a COI is to ensure that the secondary interest do not undermine researchers
and providers decisions and actions regarding those primary interest nor undermine trust in
clinical or scientific judgment(Field & Lo, 2009, p.46). Furthermore, the primary interest that
the COI seeks is based on the professional activity that include promoting and protecting the
integrity of research, the welfare of patients, and the quality of medical education. The
secondary interest include financial gain, desire for professional advancement, recognition for
personal achievement, favors’ to patients, associate , etc.( Field & Lo, 2009,p.46- 47). With
these descriptions and example regarding COI, from the clinical research trail case study of
coughgone, the examples of COI sprouts from the questionable Integrity of the these researcher,
the organization towards approving this drug based on assured compliance of the ethical
principles guiding conducting clinical trials research, most importantly towards the safety of the
consumer population from the outcome effect of the drug trial with reflection on the following
points:
1). The scientific credibility of the researcher, with the knowledge the that researcher “DR.
Smith was on probation because of fraudulently fabricating data while treating patients, thereby
violating with the ethical standards and regulation of data collection process or integrity that do
not measure up with adherence to good clinical practice
2). The review board protocol adherence and monitoring/review may have been faulted because
the organization are not validly ensured that the trial followed sound ethical practices, e.g. the
company identified problems with the doctors conducting the study and failed to report, that may
result to poor or wrongful judgment of their research report on review.
3). Financial constitution and exploitation, the compensation received by the researchers and the
company’s profitability projected for the product may have attributed to overseeing the drug
approval without proper consideration of the ethical regulation and adherence of the conducting
2. the study e.g. after the approval. The researchers examines 2500 people and were paid a total of
$450 for each and the product brought in revenues of $200million.
How could they be minimized?
1).The foremost measure to minimize COI is to disclosure the conflicts. COI can also be
minimized through a form of external assessment, incorporating laws and regulations using
formal review control systems, e.g. Research ethics boards included in the protocol mandates to
determine possible confused COI in the proper conduct of clinical trials, participant’s protection,
trail result and judgment (Lemmens & Singer, 1998, p.964)
2). It would be appropriate to investigate complaints, call for applicable action and report openly
that would help to promote transparency and accountability (Ruff, 2015, p.6).
Other Clinical ResearchIssues
1). The issue of bias may have played into this case study because, the drug producing company
is a widely prominent and rich organization that have the capability to protect and save the
companies integrity from the predicted damage towards their companies scientific validity in
drug trial results, protection to participants in study and real life consumer effect outcome.
2). Publication reliability e.g. the problem of publication reliability for the adverse health reports
from taking the drug (coughgone) in comparison with the drug real world effectiveness
research/trial result. According to Pierce (2008) reliability is the extent we can consistently
depend on the source of the data (p.83).
Reference
Field, M. J., & Lo, B. (Eds.). (2009). Conflict of interest in medical research, education, and
practice. National Academies Press.
Lemmens, T., & Singer, P. A. (1998). Bioethics for clinicians: 17. Conflict of interest in
research, education and patient care. Cmaj, 159(8), 960-965.
Pierce, R. (2008). Evaluating information: Validity, reliability, accuracy, triangulation. Research
Methods in Politics: A Practical Guide. Sage Publications, Canada.
Ruff, K. (2015). Scientific journals and conflict of interest disclosure: what progress has been
made?. Environmental Health, 14(1), 45.