medical ethics,regulations and clinical trials

Section B: Case Study

The following case study is an interventional clinical study. Read the following case study.
Answer all questions and justify your answers with your knowledge of national and international
ethical frameworks and guidelines. Do not include personal opinions.

[50 marks]

Case Study: Research Biopsies
Clinical biopsies are performed to diagnose pathological conditions and inform patient care.
Research biopsies, on the other hand, are collected for scientific reasons to understand
fundamental biological processes and/or disease progressions with the aim to improve diagnosis
and treatment. However, they may not offer direct benefit to participants despite having known
associated risks. Research biopsies can involve easily accessible tissues (e.g. skin, bone marrow),
which is considered low risk; or invasive procedures involving potentially serious complications
(e.g. bleeding, pneumothorax, infection, death).
Cancer clinical trials very often involve invasive biopsies solely for research purposes. Many
protocols include research biopsies as mandatory condition for trial participation (e.g. study
participants selection, treatment regulation, determining dosing). It has become the norm to
perform biopsies to evaluate biomarkers in clinical trials. These biomarkers are thought to
contribute to the development of new drugs and improve patient selection for precision therapy,
without direct benefit to the participant.
These so called non-integral biomarkers are used to address secondary or exploratory objectives,
which do not pre-identify specific biomarkers and/or statistical analysis plans. These study
results do not need to be reported on and often are not published.
Furthermore, the scientific value of exploratory analyses is variable and questionable.
Between 2005-2010, 57 cancer clinical trials were identified, of which 67% involved at least one
mandatory biopsy per patient. The analysis of the research biopsy tissue was a study end point in
95% of trials. The primary indication for a research biopsy was for nonintegral biomarkers in
68% of trials. A statistical analysis plan for these was not described as exploratory in 51%, and
not mentioned in 23% of trials. In >70% of cases mandatory biopsies were an eligibility criterion
for trials. Research biopsy–related risks were discussed in five consents.

1. Which ethical principles of the latest amendment of the Declaration of Helsinki should
apply when research biopsies are taken?

[10 marks]
2. Critically evaluate whether the use of research biopsies in clinical trials between 2005-
2010 adhered to ethical principles set out in the Declaration of Helsinki (indicative word
limit: 250 words).

[5 marks]

3. Informed consent.
Among all cancer clinical trials, research biopsies were also taken from five participants who
suffered from mental health problems and two primary school children.

a. What does the Oviedo Convention state about informed consent?

[5 marks]

b. Has fully informed consent been given by all study participants who took part in
the trials between 2005-2010 to provide research biopsies? Justify your answer.
[3 marks]
4. During one of the clinical trials, a study participant experienced severe complications
after a research biopsy was taken. The participant required long-term hospitalisation and
ultimately passed away due to the complications.
a) Who was responsible for the participant’s well-being and safety? Justify your answer
using ethical guidelines and documentation.

[4 marks]

b) Should the study have been terminated and current policies regarding
experimentation with human subjects been assessed? Justify your answer.
[3 marks]

c) Design a fictional clinical trial which includes research biopsies as endpoint measure.
Consider Good Clinical Practice (GCP) guidelines, national and international ethical
frameworks, and guidelines as well as clinical standards. Consider key aspects of
clinical trial design (indicative word limit: 500 words).

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