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 ClinicalTrials.gov 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).

Get 20% Discount on This Paper
Pages (550 words)
Approximate price: -

Try it now!

Get 20% Discount on This Paper

We'll send you the first draft for approval by at
Total price:
$0.00

How it works?

Follow these simple steps to get your paper done

Place your order

Fill in the order form and provide all details of your assignment.

Proceed with the payment

Choose the payment system that suits you most.

Receive the final file

Once your paper is ready, we will email it to you.

Our Services

Quality Custom Writers has assembled a team of highly skilled writers with diverse experience in the online writing circles. Our aim is to become a one stop shop for all your Academic/ online writing. Check out below our amazing service!

Essays

Essay Writing Services

At Quality Custom Writers, we prioritize on all aspects that creates a good grade such as impeccable grammar, proper structure, zero-plagiarism, and conformance to guidelines. The principal purpose of essay writing is to present the author's evaluation concerning a singular subject about which they have made. Since Professionalism is the mother of every success, try our team of experienced writers in helping you complete your essays and other assignments.

Admissions

Admission Papers

You have been trying to join that prestigious institution you long yearned for, but the hurdle of an admission essay has become a stumbling block. We have your back, with our proven team that has gained invaluable experience over time, your chance of joining that institution is now! Just let us work on that essay.How do you write an admission essay? How do you begin the essay? For answers, try Quality Custom Writers Now!

Editing

Editing and Proofreading

Regardless of whether you're pleased with your composing abilities, it's never an impractical notion to have a second eye go through your work. The best editing services leaves no mistake untouched. We recognize the stuff needed to polish up a writing; as a component of our editing and proofreading, we'll change and refine your write up to guarantee it's amazing, and blunder free. Our group of expert editors will examine your work, giving an impeccable touch of English while ensuring your punctuation and sentence structures are top-notch.

Coursework

Technical papers

We pride ourselves in having a team of clinical writers. The stringent and rigorous vetting process ensures that only the best persons for job. We hire qualified PhD and MA writers only. We equally offer our team of writers bonuses and incentives to motivate their working spirit in terms of delivering original, unique, and informative content. They are our resources drawn from diverse fields. Therefore your technical paper is in the right hands. Every paper is assessed and only the writers with the technical know-how in that field get to work on it.

Coursework

College Essay Writing

If all along you have been looking for a trustworthy college essay service provider that provides superb academic papers at reasonable prices, then be glad that you search has ended with us. We are your best choice! Get high-quality college essay writing from our magnificent team of knowledgeable and dedicated writers right now!

Coursework

Quality Assignment/Homework Help

We give the students premium quality assignments, without alarming them with plagiarism and referencing issues. We ensure that the assignments stick to the rules given by the tutors. We are specific about the deadlines you give us. We assure you that you will get your papers well in advance, knowing that you will review and return it if there are any changes, which should be incorporated.

× How can I help you?